The main purpose of this paper is to share the Mentoring for INnovative Design Solutions (MINDS) Scholars Program developed by Alpha Eta Mu Beta, the International Biomedical Engineering Honor Society. The program’s goals are to (1) introduce biomedical engineering students to an open-ended design experience as part of interuniversity teams with industry and faculty mentors, and (2) develop the ability to create designs considering clinical translatability on teams with different backgrounds and areas of expertise. MINDS uses an experiential learning approach to (1) enrich student curricular experiences through inter-institutional collaboration, (2) build engineering design skills, including three key design considerations for clinical/commercial success: intellectual property protection, regulatory strategy, and market identification; and (3) emphasize the importance of end-user considerations. From 2015 to 2022, MINDS has involved 131 students from 50 universities and 22 faculty and industry mentors. Pre- and post-program surveys show statistically significant improvements in understanding of the design process, regulatory strategy, intellectual property protection, market definition, and key product requirements and features. Students also improved communication and teamwork skills. Many students indicated that MINDS participation made them more likely to choose careers that involve product development and/or entrepreneurship. Students attained a working ability to integrate market needs, regulatory strategy, and intellectual property considerations into the design process. They also further developed soft skills, such as conflict resolution, time management, and effective communication through the challenges of inter-institutional collaboration. Additionally, the program heightened their awareness of how biomedical devices and technologies can benefit society. EL activities have been incorporated as early as first year introduction into biomedical engineering courses,4 as well as courses later in the curriculum, and in capstone design.5 For such experiences, the emphasis tends to focus on technical problem solving, as well as critical elements of the engineering design process, including problem and needs identification.Experiential learning (EL) enhances the depth to which engineering students grasp technical concepts and their ability to apply learned concepts to solve new real-world problems.6 Also, additional important professional skills that are recommended as areas of emphasis in BME curricula are communication, presentation, and teamwork skills, and there is a recognized need to expand coverage of these skills beyond senior level capstone courses.7 Finally, the historic lack of consensus of the BME identity has led to inconsistent student perceptions of what it means to be a biomedical engineer, particularly in the context of becoming employed.8 Potential solutions for covering BME curricular gaps can involve student and professional organizations.Considering the impacts of EL, opportunities exist to apply EL to advanced-level engineering skills to address gaps in BME curricula that often challenge student preparedness. First, student design experiences may or may not provide students with the opportunity to learn about important elements of commercializing medical device solutions. Yet there continues to be demand in industry for undergraduates who understand basic principles of medical device regulation, intellectual property, and market considerations for medical devices.1 These findings further support the opportunity for filling in BME curricula gaps through organizationally-initiated EL experiences. Student organizations provide an extra-curricular context for experiential learning to contribute to professional development, including leadership, communications, and professional identity.9 Additionally, involvement in professional engineering organizations improves rates of persistence and identity development of underrepresented and minority students in engineering curricula by providing networking opportunities, access to professional resources, and reduction of perceptions of isolation based on gender or race/ethnicity.10 A next leading approach would be for organizations to integrate EL programs to further enhance student preparedness.In a recent review of EL in undergraduate engineering education, Jamison et al. noted a specific gap in research on impacts of experiential learning models in co-curricular and extra-curricular learning contexts, noting that the majority of work in this area has been on topics addressed in the classroom.Recognizing the benefits of extra-curricular EL programs, as well as the potential for such programs to develop professional skills of value for BME students, Alpha Eta Mu Beta (AHMB) developed the Mentoring for INnovative Design Solutions (MINDS) Scholar Program in 2015. AHMB is the international biomedical engineering honor society. It was founded in 1979 and now oversees student chapters at more than fifty universities. Over the past seven years, AHMB has evolved the program to introduce BME students to advanced engineering skills by guiding collaboration across different universities during an open-ended design experience. Guided by mentors from academia and industry, students work in teams to identify a problem in healthcare, formulate stakeholder needs for a potential solution, and develop a conceptual solution while considering the market, intellectual property potential, and regulatory requirements for the product. Teams work using virtual communications over the course of up to 6 months to complete a series of deliverables culminating in a final presentation of their design concept. This paper describes the objectives, logistics, outcomes, and lessons learned from the MINDS program between 2015 and 2022.The MINDS program EL environment is used to (1) enrich student curricular experiences through inter-institutional collaboration, (2) build engineering design skills, including extensive integration of three key considerations into their design which are often not as well-developed in coursework: intellectual property protection, regulatory strategy, and market identification; and (3) emphasize the importance of end-user considerations in a successful design. Students also build communication skills and are exposed to additional career pathways. Participants are selected based on a competitive application process and they are placed into diverse teams  with 2 mentors per team. Teams meet and begin working together during an initial guided workshop. After this meeting, they continue to collaborate virtually for up to 6 months to refine their designs, with support from mentors and outreach to other experts. Incremental “mini-deliverables” guide students from a basic problem description, through increasingly detailed specifications and design choices, to the final design and project report. Students and mentors are surveyed at the beginning and end of the program under an IRB-approved protocol. The information is utilized for continuous improvement of the program by the MINDS Steering Committee which is composed of AHMB officers and Board members.Program objectives Table  were desThe philosophy of the program is fundamentally experiential and focused on how learning can take place outside the classroom in a guided, structured but at the same time open, adaptive manner. Students are provided with a framework that allows them to learn by doing and that pushes them to explore different areas that are mostly unfamiliar to them. Mentors guide and mold this discovery journey to maximize learning, while allowing students to figure out their own path. Teams are given a general prompt for a design idea that allows them a considerable degree of freedom to choose their topic area, and then they are provided with checkpoints along the way to promote accountability and steady progress. The program strives to achieve a balance between supporting students and allowing them to be responsible for their learning. Projects are student-driven, and each team collaboratively decides on a project topic of their choosing. They refine and define a problem statement based on their chosen topic, with input and guidance from their mentors. Problem ideas are usually based on the ideas written in their program application, but this is not a requirement. An important note is that teams are primarily formed based on the integration of students across universities and academic levels versus ideas.Students are selected in a nationally competitive process. Beginning in late summer, emails that describe the MINDS Scholars Program and the application process are sent to Biomedical Engineering and Bioengineering department chairs across the US and to AHMB chapter advisors. A FAQ sheet is also sent for posting where students will see the information.Students must complete an application for consideration. Membership in AHMB is not a requirement for acceptance. In their applications, students identify an unmet need for a biomedical device or technology (innovation) and its potential impact. The general theme for the MINDS Program is “Biomedical Engineering Design for Unmet Health Care Needs”, which provides ample freedom for students to select a topic area of their interest. Applicants are judged on the quality and novelty of the design idea and their potential impact statement. They also write a brief essay describing their interest in participating in the MINDS program and their related experiences, if any. Scholars are evaluated independently by three MINDS Steering Committee members who use a rubric to assign scores to each application. Students with the highest average scores are considered for the program. The statements on related experiences, if any, are used to ensure that teams have at least two students with some project/design experience that can be peer mentors to those with little or no such experience. The students’ design ideas are used to group students with related interests into teams of three to four students who are then matched with two mentors. Gender, institutional, and geographical diversity are also established when assigning students to teams.One of the key aspects of the MINDS program is working with peers and mentors from different institutions, and this has been emphasized in the most recent cohorts of the program. Introducing students to inter-institutional collaboration provides repeated experiences for students to improve their communications skills and discipline to adhere to schedules, especially when members are in two or more time zones. Each team has two mentors. The primary mentor helps the students navigate the ideation process and the key design considerations. This mentor also provides a point of accountability for students to stay on their timeline for deliverables. The secondary mentor complements the primary mentor’s perspective and background during the ideation and refinement processes, increasing the resources for students, and ensuring that at least one mentor is available during team meetings. Sometimes, students need specialized expertise. Mentors use their professional networks to help students connect with experts.Conference grants from the US National Science Foundation have provided the funding required to provide travel grants for students to attend the initial MINDS Workshop as well as defray a portion of the costs for hosting the event. The Workshops have been funded in this manner from 2016 to the present.An overview of the components of the MINDS program is illustrated in Fig. The MINDS workshop that initiates the MINDS program is typically timed with the Biomedical Engineering Society (BMES) Annual Meetings. Due to the COVID-19 pandemic, the workshop was offered virtually in 2020 and 2021, and was coupled with virtual registration for the BMES Annual Meeting. The Scholars’ educational and professional development is further enriched by attending poster sessions and oral presentations as well as the conference’s networking events.Each annual workshop lasts approximately 2 hours and begins with a brief welcome and an overview of the program, including timelines, expected deliverables, incorporation of the three key considerations into the design process, and use of the program’s online resources and team collaboration sites. Since 2018, there is also a short presentation from a previous MINDS Scholar who talks about their experience and gives some general tips about how to succeed in the program. Next, the group breaks into their preassigned teams of mentors and students to share schedules, communication preferences, interests, and plans for the program. The final portion of the team meeting is spent with mentors guiding an initial ideation process and discussions of the three key considerations for two or three of the design ideas. This process is not intended to result in a decision to proceed with a specific design. Rather, it is for students to immediately begin using some of the processes and tools that they will use and refine throughout the program.During the team meetings, one or two facilitators circulate between teams ensuring that participants stay on schedule, helping them navigate online resources, and reporting back to the workshop leaders on the teams’ progress. At the conclusion of the workshop, a facilitator summarizes the progress made by teams, reminds participants where to find post-workshop resources, reviews the due dates of future deliverables, and provides a survey link. The survey assesses the knowledge gained from the workshop, its ability to stimulate ideas, and requests comments to improve the workshop. In this survey, participants are asked to write at least one main concept for each of the three key design considerations. Mentors are given a survey to evaluate the performance of the students and their apparent level of understanding of key concepts, the ability of the workshop to stimulate ideas, and to suggest improvements. All surveys and dissemination of the results have been approved as exempt by the Institutional Review Board of  Nova Southeastern University.Information on the Food and Drug Administration (FDA) regulatory requirements, intellectual property protection, and basic marketing procedures are provided to participants and mentors to assist teams to more effectively develop their plans to address the program’s three key design considerations. This information is available in an online repository and includes tutorials, websites, and links to webinars; and is updated yearly as needed or as new resources become available. Students are also encouraged to attend any other BMES annual meeting sessions that may be related to their topic or to design considerations. In addition, the MINDS Steering Committee has produced and recorded topical webinars and in-person BMES conference sessions featuring experts in the fields of regulatory strategy, intellectual property protection, and marketing of medical devices to provide detailed information that is specific to the medical device and diagnostics field.Initially, webinars on a specific topic, such as regulatory strategy or IP strategy, occurred after the BMES meeting during the first six weeks after the initial workshop. Students and mentors participated from their home institutions. Since participants could view the recorded sessions asynchronously, relatively few participated during the live event. In subsequent years, live workshops were held during the BMES Annual Meeting the day after the MINDS workshop. These sessions were open to all BMES Annual Meeting attendees, which more than doubled the number of students exposed to the content.Live sessions and webinar speakers included industry professionals in regulatory affairs and intellectual property (IP) consultants and lawyers, and speakers with marketing and entrepreneurial experience. Each live session and webinar provided ample time for students to ask questions. All events were recorded so that students could review the content, as needed during the design process. The talks on regulatory strategy and IP protection were especially valuable. Together, they highlighted the challenges of striving to show the novelties of a medical device to obtain patents while satisfying the need to show substantial equivalence to an existing medical device to streamline the FDA approval process. Due to the implementation of COVID-19 restrictions in 2020 and 2021, the live session was canceled but students had access to recordings from previous years.After the workshop at the BMES conference, students and mentors meet virtually for up to 6 months to finish the ideation process, choose a design, and then refine it. During these processes, Scholars use the three key considerations to produce a marketable product design that has the potential for FDA approval, patent protection, and a positive impact on the people it is intended to help. Based on early experiences with the program, it is recommended that teams meet twice per month; however, teams are allowed freedom to plan their schedule and project timeline. Scholars are encouraged to find subject matter experts to provide them with specialized knowledge in areas such as market evaluation, patenting devices, and determining regulatory pathways for their device. Sometimes, advice from an expert in a particular field of manufacturing or medicine will help a team improve its design or make it more relevant for a particular patient population. If needed, mentors provide direction on where students can find experts and how to ask for assistance.Teams are given a set of mini-deliverables with deadlines. Mentors remind students about deliverables, if warranted. Students are responsible for submitting each deliverable to the project’s online repository. Originally, larger components (milestones) were achieved over several weeks or months. Student and mentor feedback suggested that this long-term model could become overwhelming for the teams. The mini-deliverables reduce large project components into smaller, more easily achieved tasks which are due more frequently. Examples of deliverables include prompts such as “describe your problem” , “the three key design considerations” , or “virtual prototype” . Students have 3 or 4 weeks to complete each of the tasks and submit them.At the conclusion of the program, each team has a refined product design. Scholars create a report which can range from a traditional written report with tables and figures to a mock website or video promotion. All reports must show how Scholars used the key design considerations in their design process, how they have considered end-user needs, and their reflection on the learning process. Students are provided with report guidelines at the beginning of the program, which include all the sections that must be covered in the report and some guiding prompts for each section. This ensures that teams have a clear set of expectations of what they need to accomplish by the end of the program. At a minimum, the report must include: (1) Introduction, (2) Description of the design process, (3) Description of how the three design considerations  impacted the design, (4) Description of the proposed device or solution, including benefits and comparisons with existing technology, (5) End-user considerations, (6) Reflection, and (7) References.For the 2020–2021 cohort, a closing event/virtual design showcase was added after the due date of the final report which was held in April 2021. Prior to this cohort, project reports were shared online but there was no final interaction or discussion of the different projects between teams. Student feedback uniformly suggested that they would like to actively learn more about what other teams had done. The first closing event in 2021 was simply an informal gathering with opportunity for discussion, and no formal expectations were placed on the teams. Although this was meant to avoid putting additional pressure on participants after having turned in their final report, it also meant that there was high variability in attendance, as well as in the quality of what each team shared. For the 2021–2022 cohort, more structure was added in order to fully realize the vision of the closing event. Each team had ten minutes to describe their design with appropriate drawings, tables, and other visuals, followed by some time for questions and comments from peers and mentors. Students were very receptive to this format and excited about attending this event, sharing their work with others, and “graduating” from the program.Besides the initial survey completed after the workshop, which focuses more on initial logistics, demographics, and the level of knowledge of incoming participants in terms of the design considerations, Scholars and mentors also complete an exit survey which is open for up to 3 weeks after submission of the final report. In this exit survey, students are asked to rate the perceived impact of the MINDS program on the key skills that are defined by the program learning objectives, including collaboration, design requirements, evaluation of market needs, evaluation of intellectual property considerations, development of a regulatory strategy, and communication of technical information. Questions on some of these items are broken down into more granular sub-skills when necessary, in order to refine survey data and allow for its use in continuous program improvement. For instance, students were asked about objective 2, “formulate a list of key design requirements” not as an overall question but rather as part of several survey items. These included, for example, ability to apply the 3 key design considerations, articulate key features of a product, or articulate key benefits and impact of a product. The wording of specific questions included in the survey is detailed in the results section along with the response analysis. Students were also asked to provide open-ended comments about program logistics, what they liked or disliked about the program, whether it had impacted their engineering skills or their career plans, and any other comments they wanted to make on their experience. Similarly, mentors were asked to rate student skills in the key areas, and to provide feedback on the program.Data from surveys was imported into Excel for de-identification and to aggregate all cohorts. Quantitative data was then processed in SPSS 28  to create frequency tables and to compare pre-and post-program perceived knowledge in key areas. Comparison was done using Wilcoxon signed-rank tests due to the ordinal nature of the data. Multiple comparisons were accounted for with a Bonferroni correction .Qualitative data analysis followed an inductive approach, where open-ended comments in the exit surveys were systematically analyzed using the constant comparative method. The analysis was guided by specific learning objectives as well as the characteristic components of experiential learning. Briefly, comments were extracted from the surveys and placed into categories determined by the key content of the comment in relation to learning objectives, target outcome skills, or the lived experience of experiential learning. Categories were cross-compared to determine connections into core categories and patterns, which were then built into major themes that summarized the overall intent of the related categories. Two initial rounds of coding were completed, with participation from all 4 authors to refine core categories, analyze overlaps, and build themes. A third round of discussion was utilized to ensure theoretical data saturation and finalize themes.A total of 131 students successfully completed the MINDS program between 2015 and 2022. Collectively, they worked on 34 projects that spanned a multitude of areas chosen by the teams. Topic areas for projects from 2020 to 2021 and 2021–2022 are provided as a sample in Table Demographic information on MINDS participants is shown in Table A total of 22 different mentors have participated in the MINDS program between 2015 and 2022, from a total of 18 different institutions. The majority of them (72.7%) have mentored multiple cohorts, which contributes to continuity and consistency of the program. Of these mentors, 4 (18.2%) have their primary job position in industry, and 18 (81.8%) have their primary job position in academia; all mentors except for one have doctorate degrees (the remaining mentor has a master’s degree). Mentors came primarily from the Southeast and Midwest regions of the U.S. In the initial years, groups had one mentor each, but starting with the 2017–2018 cohort, a two-mentor model was implemented in response to student and mentor feedback that recommended having two mentors available to help with group logistics, as well as to expose students to a variety of backgrounds and expertise.Student outcome surveys demonstrated that student self-reported knowledge increased significantly in all key content areas that are targeted by the program, including design process, regulatory strategy, intellectual property protection, the patent process, and marketing considerations Table . As expeIn the exit survey, students were also asked to evaluate the impact of the MINDS program on their skills in several areas related to the program learning outcomes, including not only specific design-related skills but also soft skills, such as communication or teamwork. The results are shown in Table Mentors who have served in different cohorts report being pleased to see how the program has grown and been refined over the years, and have provided feedback for continuous improvement as part of their surveys and through discussions with the MINDS Steering Committee. In general, mentor-reported outcomes matched the improvements perceived by the students. Although mentors tended to rate student knowledge a little lower on average than the students themselves (both pre- and post-MINDS), they did agree that their teams had improved their knowledge in all key areas, and that they had enhanced their engineering and soft skills. Like students, mentors had different experiences in different teams. Mentors reported enjoying the brainstorming process with the students and the opportunity to guide them through the different ideas and options for their design, as well as connecting them with experts in the field. Mentors reported that one of the main challenges was pushing students past the idea generation stage into making a definite choice, as well as keeping the team motivated for several months in the face of academic and personal competing interests. Overall, the mentors agreed that the MINDS program was a stimulating platform in which new ideas could be born and nurtured to maturation.Table Students also provided many open-ended comments in their exit surveys. The question prompts were: “What aspect of your MINDS Scholar experience did you enjoy the most?”, “What aspect of your MINDS Scholar experience was the most challenging?”, “Do you have any comments on how the MINDS workshop has impacted your engineering skills?”, “Do you have any comments on how the MINDS workshop has impacted your career goals?”, and “Please provide any additional comments”. Yearly, the survey comments from both students and mentors were reviewed and utilized for continuous improvement. For instance, the inclusion of periodic mini-deliverables, the progression to a two-mentor model, as well as the introduction of a closing event where the different projects were showcased so all students could learn more about each other’s projects were all results of this continuous feedback process. Students were generally very grateful to have participated in the program and very vocal about how it is a unique opportunity, with comments such as “This program is fabulous!! It needs more recognition and promotion around the BME community. I think it would be a fun idea to have these presentations/reports be accessible to more BME students.” Comments from 2015 to 2022 were analyzed for overall themes. There were 7 main themes: learning by doing , learning outside the classroom (where students commented on how the experience was different from their regular curricular activities), learning from challenges (where students spoke about how they encountered barriers and how they overcame them), teamwork and networking (where students discussed team dynamics and the connections they established within and beyond teams), communication (where students expressed how the program had impacted their ability to disseminate information or to communicate with others), value of mentorship (where students emphasized how mentorship impacted their experience), and impact on career/carryover to professional skills . Supporting illustrative quotes are provided in Table The major contribution of this paper is the introduction of the MINDS program as an extra-curricular design program that connects students and faculty across biomedical engineering departments. The interuniversity experience uniquely exposes students to different learning environments  and serves to build confidence by expanding advanced engineering skill sets. The diversity of the learning environment is supported by the number of student host universities. Student participants create a novel product idea, describe how they used the key translational design considerations in the product design process, and will be able to state the features, benefits, and impacts of their products through production of a promotional presentation for their product. In addition, MINDS introduces students to project management and engineering soft skills through a unique real-life experience. The MINDS program expands the breadth of extracurricular EL models with an innovative approach highlighted by the inter-university student teams, interaction of students across freshman, sophomore, junior, and senior levels, and the involvement of academic and industry mentors. The peer-to-peer active learning model promotes the sharing of environments and may in turn help build confidence. This speculation is supported by the observed learning impacts on the students regardless of their level and motivates exploration of similar types of peer-to-peer interactions. Additionally, mentors identify the opportunity to interact with students and with other mentors from different universities as a valuable aspect of MINDS. A clear student benefit of the program outside of experiencing the design process is forming relationships with the mentors that they would not otherwise have had, being at different universities. These relationships often result in requests for recommendation letters, additional mentoring, and direct impacts on student careers.The MINDS program was a first team-based design experience for many of the students and further supports the value of EL which was recognized by student appreciation of learning by doing, learning from challenges, teamwork and networking, communication, value of mentorship, and the program’s impact on their career. Although our thematic analysis is limited by its purely qualitative approach, there are clear connections between identified themes from student comments and acquired skills, as demonstrated by the quantitative portion of the analysis. Comparisons of pre- and post-experience surveys support student learning in knowledge of key areas: product development, regulatory strategy, intellectual property protection, the patent process, and marketing considerations. There were significant increases (p < 0.001) in perceived knowledge in all key areas targeted by the program. In addition, our results support an impact of experiential learning on self-reported skills including a variety of product design-related requirements and the ability to collaborate and communicate effectively. Only two out of thirteen skills fell below 90% for responses of agreed or highly agreed. These were related to resolution of conflicts (67.5%) and the roles of personnel in product development (69.1%). Regarding the roles of personnel in product development, this was not generally emphasized in the program, and exposure to this aspect depended highly on the outreach activities that were freely initiated by students and their mentors, thus varying from team to team. Regarding conflict, some students pointed out that they did not feel conflict resolution was a focus of their experience, because they did not have conflicts in their team, so they did not perceive that their skills in this area had necessarily changed. During the initial workshop, mentors emphasize the importance of communication and identify that conflicts are to be expected. The requirement of deliverables serves to hold students accountable and a focus on making design decisions based on data-supported rationale encourage discussion of known information rather than student opinions. This approach helps to minimize conflicts, yet conflicts of course do occur. The meeting formats complemented by the sharing of personal experiences by students and mentors (i.e. getting to know each other) encourage teamwork and communication when conflicts do arise. Most importantly, mentors use conflicts as a teaching moment, focus on solutions identified by the entire team, and ensure students that their experiences will be OK moving forward. Another thing mentors do is encourage constructive approaches to decision-making very early by recommending systematic approaches to selecting the project idea from the list proposed by the team. This sets a tone that teams tend to carry forward in making future decisions.The interuniversity interactions serve to build skills in long-distance collaboration. At the start of the MINDS program 7 years ago, this type of interaction was not common. In early year surveys, numerous students mentioned long-distance collaboration as an important professional development outcome from their participation in the program, but also as a skill with a steep learning curve. During and post pandemic, remote coordination has become common and a critical soft skill. Thus, the changing academic and professional environment has increased the impact of collaboration on professional skills. Recently increased exposure to online collaboration formats as part of regular curricula has improved the ability of the last two cohorts to work effectively in a remote environment, however, student challenges related to communication, time management and teamwork challenges still remain as students adapt to an environment where they must take initiative in their own learning.MINDS being an optional program means that, compared to the general student population, participants are generally more self-motivated to learn marketable skills, satisfy expectations of teammates and mentors, expand their professional network, and complete a professional activity for their portfolio. Still, sustaining motivation for an extracurricular project over the span of 6 months, while managing time in the face of competing school and personal responsibilities and conflicting schedules, continues to challenge teams over the years. Historically, 4 out of 135 total students who were initially selected for MINDS disengaged at some point in the process and did not complete the program. While we do not always know for sure the reasons, we speculate some of these students realize the extracurricular and long-term commitment and are unable to continue. However, the reasons are not always negative or easily predicted—for example, at least one of these students could no longer participate due to the starting of a full-time job. Overall, the high rate of program completion reflects an appreciation of the experiential value by the student participants. Team dynamics and team and program support are critical external factors that can impact a student’s ability to complete the program despite other challenges.One of the critical roles of MINDS mentors is guiding team dynamics and project management. These are especially important given the different experience levels of the students. As an example of how team meetings are guided to encourage peer to peer interactions and workload distribution, mentors emphasize the importance of deliverables. During each meeting, students distribute deliverables to be shared during the next meeting. These deliverables are typically PowerPoint slides and CAD files, and these represent information or tasks necessary for the next step in the design process. Another complementary strategy used by mentors is to review the timeline and upcoming milestones so that students recognize how their contributions build upon each other. With these strategies being noted, the challenge of workload distribution is not straightforward to address and common to most teams. However, the requirement of student assigned deliverables helps promote a feeling of accountability and peer interactions. While we do not explicitly list peer mentoring as an expectation at the start of the program, mentors look for ways to encourage peer to peer mentoring based on different backgrounds and knowledge on the team. As an example, one of the students in a recent cohort had taken a course on medical device commercialization, and she provided constructive advice and feedback to teammates who were working on regulation and marketing.As is the case for any EL program, student impact can be indeed appreciated through the challenges, and another consistent challenge for students is making decisions. In particular, teams often struggle with settling on a design topic during the first stages of the project. Mentors must guide students to make decisions through the design process by stimulating questions such as... What problem do we choose? What design concept should we select? How do we select design details? To provide adequate guidance without stifling student ownership of the learning process, a goal of the mentors is to push students along and emphasize rationale-based iterations Fig. . The MINAn interesting aspect to contemplate as the program continues to grow is that while students are exposed to patents and the role of intellectual property in commercialization of a product or starting a company, the current focus of the program does not formally address the students’ roles as inventors. Team mentors are coached to guide progression of the student teams through the design process rather than influence the idea generation. With this being noted, an opportunity moving forward is to leverage the experience to make students aware of their roles as inventors. Based on experiences at our universities, students own their ideas. So, we expect that the students in the program own their ideas and the universities do not have ownership. Going forward, a formal definition of student intellectual property needs to be developed in consultation with university technology transfer offices to explore how this design experience should be best handled.In summary, through participation in MINDS, students learn how to incorporate assessments of marketability, intellectual property protection, regulatory strategy, and end-user considerations into their design process since these are crucial to successful translation. As these topics are often not covered in rigorous detail in the standard engineering curriculum or not covered multiple times in a BME curriculum, the program supplements or reinforces classroom learning. The MINDS program also provides an opportunity for students to develop soft skills, such as conflict resolution, time management, and effective communication through the challenges of inter-institutional collaboration. After 7 years of offering the MINDS program, student feedback supports that the extra-curricular EL opportunity additionally has resulted in the discovery of new career options and improved communication skills. An additional positive aspect of the MINDS program that we look forward to leveraging more in future years is the ability to connect students from smaller or less-research active universities with students in larger departments, and to provide them with further exposure to people in the BME field and the many types of career tracks that are available. Our modular foundation allows for future program expansions to increase broader impact, and as the program continues to grow, there are opportunities for further exploring program outcomes across institution types  and/or specific participant demographics. Another aspect we would like to explore is longer-term curricular impact, in particular surveying graduates of the MINDS program 1 year after their experience in order to assess the effect of MINDS on curricular components such as the senior design course or other design-related courses. The success of the MINDS program demonstrates the value of innovative EL approaches and a role for national societies in enhancing student teaching. We hope that the MINDS program can inspire other curricular and extracurricular activities that maximize student involvement in experiential learning, collaboration, and discovery.


In this paper, we present a case study of Pakistan documenting the use of antimicrobial drugs in poultry flocks in the VetCAb-ID database. Unlike other databases, this system allows international users to upload their data directly. Based on expert interviews and a review of the latest publications on the topic, we provide an alternative approach to harmonizing data collection among countries. This paper will provide impetus to formulate joint requirement documentation for an AMU database on a global level that international users can adapt for their own purposes and projects. In recent years, Pakistan has upsurged its ambitions to combat the antimicrobial resistance (AMR) of bacterial pathogens. Monitoring antimicrobial drug usage (AMU) at the farm level is the first and indispensable step to achieving this goal. This case study presents how the international VetCAb-ID  database was used and adapted for the digital monitoring of AMU in Pakistan. Monitoring AMU in the database presented here involves the systematic documentation of data such as frequency, amount and active components of antibiotics, animal species treated, periods of harvesting and other additional data points. Bringing data together facilitates the analysis of metrics such as treatment incidence and daily dose of drugs used, providing benchmarking measures for farms, regions and countries with regard to AMU .Part of this study focuses on organizing the direct data input of VetCAb-ID users and thus follows a recent shift in perspective within the community. While analyzing AMU/AMR was used to develop corresponding policies for collective action, discussions are now moving towards elaborating how to generate a common digital infrastructure to collect data on a global scale  or the World Organisation for Animal Health (WOAH) global databases ,3,4,5). This study elaborates on this assumption and aims to share experiences of using the international VetCAb-ID database in Pakistan. For example, challenges, benefits, sketches from the database, user roles and examples of data from two farms in Pakistan are provided and discussed. To compare and contrast the findings of this case study with the results of previous case studies, a literature review was conducted. Here, we have found that VetCAb-ID is one of the few databases that allows users to collect primary data through direct entry. Hence, the challenges and solutions presented may be seen and discussed as an alternative data collection approach to consider for future shared global databases.The results of this study begin with findings from the literature review, which describe the types of shared databases and related challenges and benefits that have already been discussed in the literature. Subsequently, results from our case study, including the expert interview and descriptive analysis of the poultry data of Pakistan in VetCAb-ID, are provided.In general, publications evaluate databases for AMU/AMR at the farm  or natioA feasibility study of a data collection system in Germany was published at the national level. The system was considered adequate when the data allowed for comparisons among specific entities, the calculation of descriptive statistics and the analysis of how to generalize upon the results . HoweverSimilarly to the German study , the benAnother topic that is frequently discussed is the quality of the collected data. Lastein et al.  focus onWith regard to data quality, another aspect that is discussed is how illiteracy influences the data collection process, impacting both the ability to read and understand the importance of reporting certain details about the process or antibiotics administered for database documentation ,14. BesiIn a joint study by the University of Agriculture in Faisalabad (UAF) and the Department for Biometry, Epidemiology and Information Processing (IBEI), the feasibility of monitoring AMU using VetCAb-ID was assessed. This section begins with a description of the basic features of the database. In the next section, interview results regarding the documentation process, starting at the farm level, will be presented.VetCAb-ID is a database used at a global level that aims at providing a web-based infrastructure to users in the field of AMU in the veterinary field (see more context information in the “Methods” section). As one of the first steps, the administrators of the IBEI set up a domain for users to enter and analyze data jointly. A domain can be a project at a national, regional or university level and may or may not allow other domains to view or use the data within that domain. The database offers a set of basic forms to file farms , harvesting periods and treatments for these animals. To file treatments, animals and farms, the database offers predefined items that can be modified if they are incomplete for a domain. For each user, the database provides an overview of filed farms, veterinarians supervising the farms, animals and therapies (treatments) filed during a certain period see .Preparing the VetCAb-ID database for international users requires extensive translation and discussions about appropriate terminology and the extent to which data input is compulsory. Moreover, defining roles and distributing rights in the database for administrators, domain or data editors and readers of entries in the database is needed to establish data security issues.To overcome the common challenges faced by new users, three paper-based manuals and online training videos have been created and shared to explain how to use the VetCAb-ID database. The manuals address project norms, rights, legacies and data structures. They provide a checklist for what to consider when setting up the database and which user roles may be distributed. Roles include, for example, administrators , domain editors , data editors (who are project members and may enter therapy data for farms) and readers .Besides written manuals, learning videos are available to explain and demonstrate how to use VetCAb-ID and how to analyze and export data from the platform . Figure Once users are familiarized with VetCab-ID, the database supports correct data input through the use of automated and manual quality checks. These checks comprise the provision of lists for entries of drugs, animals, dose units and indications, among other prefilled entry fields . In cases of false entries, the user is informed see  and may In summary, the main challenge during the development of VetCAb-ID for international users was to balance adaptive and predefined entry functionalities needed to harmonize data across domains on the one hand, while being responsive to domain/country-specific needs on the other. Furthermore, a balance between the administrative leadership of the IBEI (as the provider of the platform), the data sovereignty of the domain leaders and the distribution of rights across domains had to be found.In the joint study by the UAF and IBEI, AMU documentation begins with field veterinarians in Pakistan (poultry consultants), who first take notes and record data on-site at farms. The objective of documenting data on-site at farms is to overcome the lack of antimicrobials sales data, a common challenge in low- and middle-income countries (LMICs) . The vetThe team at the UAF consists of several researchers. Two people enter the data from the forms into the VetCAb-ID database and the other people collect the information on antimicrobial product details from the retail market or through online searching. Since data can be entered into VetCAb-ID directly, the database is used as a project repository without the need for additional infrastructure or systems. The database allows for data to be exported in interchangeable formats so it can be further used in analysis systems.Due to the challenges that appeared during the use of VetCAb-ID in Pakistan, administrative aspects need to be mentioned. One example is IBEI’s decision to keep the right to edit or remove incorrect entries to maintain database consistency. The UAF considered not having the right to edit and remove incorrect entries in the VetCab-ID platform a challenge. Small typos could not be corrected independently. Instead, an email needed to be sent to ask the administrator to solve the issue.In general, the UAF indicated that additional, more predefined forms would be needed in order to standardize data monitoring in the field. One reason is that the required information for AMU/AMR is not readily available in Pakistan, and the more information that is filed at the farm level, the more complete the records that are filed online can be. A second reason is that a harmonized form would enable it to be shared across multiple projects if this approach were to be scaled on a national level. For example, duplications of entries  could be avoided.Concerning the documentation process, another challenge for the UAF was explaining to farmers (and veterinarians) why information such as the brand and the total amount of active ingredients in an antimicrobial drug needed to be recorded in detail. Explaining why recording is significant touches upon the common understanding of the importance of how AMU is protecting both local and global health. Related to this point, the UAF indicated that a commitment to report in a timely manner was a challenge:“For field veterinarians the collection of antimicrobial usage data on our given preforms was not their main priority. Since data collection was voluntary, sometimes we faced difficulties in getting data timely as it was not compulsion. Furthermore, the COVID-19 outbreak also affected the logistics and slowed the data collection and entry”—Expert.To overcome the aforementioned challenges, the UAF suggested shifting from paper-based data gathering to a digital application to report data directly. The system would create entries in the local languages and farmers would be able to create entries themselves. Real-time, direct reporting is considered an incentive, which leads to increased commitment:“It helps farmers to keep the farm records and to compare among different flocks and months”—Expert.To increase support, urging the Government of Pakistan to devise legislation and to direct farmers to record and report the AMU data was considered a step to overcome these challenges.Regarding the VetCab-ID database, a simpler web-based database with a holistic approach  is the target. However, when asked about the benefits of using the platform, an expert summarized them as follows:“Earlier studies from our research group in Pakistan have studied antimicrobial usage data using treatment record and garbage-bins studies from food animals. Now our pilot VetCAb-ID project has provided us the first digital database of common antimicrobials brands, products and their indication in dairy and poultry farms in Pakistan. We are able to see descriptive results at the end of analysis.”—Expert.More information about entering and using specific data and their related benefits will be outlined in the next section.For the UAF, using the VetCAb-ID platform is their first time using an international platform for recording data on AMU. As outlined in the previous section, using the database presented a challenge because the requested data were not readily available and needed to be generated first:“We added more than 146 antibiotics brands, composition, and dosage forms in the database.”—Expert.On the other hand, having this data filed offers benefits due to the resulting depth of information and results over time. Moreover, the antibiotics filed can be shared across domains , which reduces the need to generate new data. Further reported benefits relate to descriptive outputs such as:“The number of therapies, treatment frequencies (TF) and indications (diseases/prophylaxis). As researchers, this helped us in better understanding of collecting and reporting AMU data and the very details to consider in implementing AMU surveillance at farm-level or national level.”—Expert.In previous papers, AMU data were estimated on the basis of import/export data from the Pakistan Customs Authority . As showA beneficial feature of the database that can be observed in this respect is that entries  are linked automatically to a corresponding identification number (ID) in the VetCAb-ID platform. Since the ID lists can be accessed, modified and exported with the domain database sheets, this documentation eases later data processing and analysis . Moreover, IDs such as the drug name are linked to other information in the VetCAb-ID database . Hence, based on the drug name, the database allows the user to analyze related information that has not yet been manually entered from a single data point entry.Here, we present a case study of VetCAb-ID being used for documenting poultry data in Pakistan. Although Pakistan uses the database for more than one animal species, and despite the fact that VetCAb-ID is used by several countries, we chose to begin with this focused and qualitative case study in order to highlight the process of data entry and specific system features. To avoid the risk of presenting incomparable results, we conducted a screening literature review to align our results with the findings in other projects. In this regard, we found that our case study provides one of the first user reviews of an international database for AMU documentation. While previous publications have focused on comparing the functionalities between databases across different countries or methods, this study elaborates on the feasibility of monitoring starting in stables. Future studies should provide systematic literature reviews and multiple case studies to increase the generalizability of the findings. Specific topics related to the discussion of our results are addressed in the following section.Regarding the documentation process, our study found that a paper-and-pen approach to recording data in stables is sufficient in Pakistan. Although commitment to submit related documents in a timely manner is an issue, data can be uploaded online regularly by the UAF team. In the future, current users in Pakistan aim to document AMU in stables with the help of digital systems. Since infrastructure may be a severe challenge to documentation as outlined in previous studies ,17 and sIn relation to the digital input of primary data, another surprising result of this study is that VetCAb-ID seems to be one of the few global databases that allows users to collect, save, export and use their data independently . Hence, regarding the discussions in the literature on whether to extend the harmonization of data records ,4,8, thiThis case study does not provide a discussion on how AMR or One Health data can be integrated and documented in a joint approach e.g., ,20). Fur. Fur20])This publication is embedded in the project “Veterinary Consumption of Antibiotics-International Documentation” (VetCAb-ID). The project runs under the umbrella of the WHO Collaboration Center for research and training on health at the Human–Animal–Environment Interface (WHO CC HAEI) at the IBEI of the University of Veterinary Medicine Hannover (TiHo). The long-term goal is to establish a concept for a One Health approach and to report AMU and AMR data jointly online. The database (VetCAb-ID) for this project is hosted by the IBEI. It was built in response to a sentinel approach of collecting antimicrobial usage data in German farms . CurrentThe data for this publication stems from a joint feasibility study of the UAF in Pakistan and Germany. The key research question is: What can we learn from using an internationally shared database for documenting the use of antimicrobial drugs across countries? The study design to answer this question is a mixed-method case study.A case study is a systematic compilation of entities bound, for example, by a project ,22. In tThe UAF in Pakistan has been one of the active partners using VetCAb-ID since the end of 2020. In LMICs, documenting the use of antimicrobial agents is rare. Pakistan has expanded its activities to address the overuse of antibiotics, especially since a significant part of the WHO-classified high-priority critically important antimicrobial (HPCIA) agents in human medicine are used in farm animals. In 2017, a National Action Plan  was lauTo consider the latest publications on the topic, a screening literature review was performed following Webster and Watson . KeywordTo provide an adequate account of the experiences with the VetCAb-ID database in particular, the UAF team acted as experts in an interview . A briefTo illustrate the functionalities of VetCAb-ID, extracts from the database and a descriptive analysis of the data in VetCAb-ID for poultry farms in Pakistan were generated. The study population stems from two large-scale commercial broiler farms with more than 25,000 chicken birds. The farms are providing AMU data on a voluntary basis. In total, two or three poultry production passages at each farm were documented. The type of poultry is defined as chickens (age: 0–42 days) raised for meat production. While the information about the farm, species and periods is filed in advance by the UAF, the data about therapies are filed by veterinarians, provided to the UAF, entered by UAF members in the database and cross-checked by IBEI members. The main calculations focus on the average treatment frequency (TF). The TF is calculated by adding up the number of recorded therapies, considering the active substance in drugs, and dividing by the population size :TF = ∑ nThis definition (1) is in line with treatment incidence, but it assumes UDD instead of DDD and body weight under therapy instead of average body weight .


Microorganisms involved in food fermentation not only improve the aroma and taste of the food, but also enhance its preservation. Thus, they are added as starter cultures to boost the final product quality of commercial fermented foods. Although these microorganisms originate from fermented foods and have a long history of consumption, the European Union recently applied the concept of Qualified presumption of Safety (QPS), which is a safety evaluation system for microorganisms used in food or feed in Europe. The QPS system is a species-level safety system and shares results with the European Novel Food System, a strain-level safety evaluation system. In the United States, microorganisms added to fermented foods are considered as food additives or Generally Recognized as Safe substance. In Korea, food microbe lists are presented at the species level. Moreover, the nation has established a strain-oriented evaluation system that applies temporary safety evaluation methods for food raw materials as well as new raw materials. However, when it comes to microorganisms isolated from traditional fermented foods and other fermented food products, there is no definition of the term “species,” and there is a lack of an evaluation system at the species level. Therefore, such an evaluation system for microbial species used in Korean fermented foods is necessary. During fermentation, macromolecules such as proteins and starch are degraded into amino acids, monosaccharides, organic acids, and volatile compounds by enzymes produced by microorganisms. This contributes to the sensory characteristics of fermented foods, which have improved sensory properties compared with the raw materials . In addiFood fermentation can be divided into natural fermentation, back-sloping, and starter fermentation, depending on the origin of the microorganisms involved. Natural fermentation involves microorganisms that are present in the raw materials or the environment. Back-sloping is a method of adding some of the fermented product to the early stages of new fermentations. Starter fermentation is the isolation of pure microorganisms that have successfully led to fermentation and their subsequent use as single or mixed starter strains for new fermentation.Before the industrial revolution, natural food fermentation was used domestically in Korea, but, as industrialization progressed, mass production systems were introduced. Natural fermentation is unreliable for mass production and can lead to economic losses due to uncertain microbial growth and inconsistent products. To overcome these problems, back-sloping was introduced, although this method opens the possibility of introducing spoilage or harmful bacteria . In starThe safety of microorganisms involved in fermentation, including starters, has been considered based on the long history of fermented food consumption. In 2010, the European Food and Feed Cultures Association (EFFCA) proposed as a definition for starters the term “food culture,” and defined food cultures as safe, live bacteria, yeast, or fungi used in food production. Various terms such as starter culture, dairy starter, and yogurt starter, can also be applied. In Europe, food cultures are classified as food ingredients, and food cultures used in food must be supported with information in accordance with European Union (EU) regulation 1169/2011.The importance of evaluating the safety of the microbiota in food cultures has been highlighted. There are two representative safety assessment systems for food cultures: the Qualified Presumption of Safety (QPS) system in the EU, and the Generally Recognized as Safe (GRAS) system in the USA. The EFFCA’s definition of food cultures was announced after the EU introduced and established the QPS concept for microorganisms used in food and feed . SomewhaMicroorganisms that have traditionally been used in food production in Europe have long been used without regulations based on a history of safe consumption. However, microorganisms used as food cultures are intentionally added food raw materials , and thus the necessity of safety evaluation was raised. The Novel Food System, which is a safety assessment system for foods that have not previously been used at a significant level in Europe, was developed in 1997. However, it was unclear whether microorganisms that were consumed in conventional fermented foods were included within the scope of the Novel Food System when used as food cultures. In addition, it was undetermined whether microorganisms identified by advances in technology, technology or not, such as newly designated microorganisms of existing species, were included in the scope of the Novel Food System.Experts of the Scientific Committee on Animal Nutrition, the Scientific Committee on Food, and the Plant Science Council on Plants of the European Commission (EC) thus proposed the QPS system concept for the safety evaluation of microorganisms used in food and feed  6, 7]. , 7. 6, 7The safety evaluation of microorganisms identified at the species level for the QPS system has four aspects : taxonomBacillus species, yeast, and fungi related to fermented food and feed  panel performs the requested microbial safety assessments for the European Food Safety Authority (EFSA), in addition to updating the QPS list. From 2016 to 2019, there were 887 requests for safety assessment to BIOHAZ, of which 40 cases were requested by the NDA  in charge of Novel Food, and 30 cases were inspected .There are many claims that the QPS system is similar to the GRAS system used in the USA. However, the GRAS system is a safety assessment system at the strain level, while the QPS considers safety at the species level, so it is different from the GRAS system, and the Novel Food system bears more similarity to the GRAS system.The Novel Food System (EC) 258/97 regulation was established in 1997 with the introduction of the Novel Food System, a safety assessment system for food that has never been used at a significant level for human consumption in Europe. Subsequently, in 2015, improvement of the Novel Food Safety Assessment System (EU) 2015/2283 led to changes in clarity of the definition of Novel Foods, centralization of administrative procedures, a transition from individual recognition systems to notification type, and reduction of safety assessment for strains used in other countries.When an applicant submits a new microbial raw material or microorganism used in the production of new food ingredients, the NDA panel requests evaluation or review by the QPS, and the BIOHAZ panel determines whether the microorganism is on the QPS list or a QPS evaluation target, and informs the NDA panel. Safety assessment of the microorganism can be omitted if it is on the QPS list. If it is not, individual safety assessment should be performed in accordance with the Novel Food System regulations.Hyphomicrobium denitrificans strain CK-275 was evaluated as not having QPS status because of a lack of information about it, but the final food product was approved as a Novel Food [Between 2018 and 2020, a total of 46 cases were listed on the EU’s Novel food list, and eight involved microbial raw materials or foods using microorganisms . Three iAs such, if the QPS system is a species-level safety evaluation system based on abundant information and a long history of intake, the Novel Food System can be seen as a component-specific or strain-level safety evaluation system.In the US, a new food ingredient is recognized as a substance intentionally added to food and is regulated under the Federal Food, Drug and Cosmetics Act (FFDCA). Although new food ingredients must be preapproved by the FDA according to the FFDCA, new food ingredients that are generally considered safe because of a long history of use and evaluation by experts are managed via the GRAS system with manufacturers submitting safety-related data and experts evaluating and notifying them.S. cerevisiae for use as starters in alcohol fermentation.In 1958, a list of substances with a long history of intake in the US was published as a GRAS list under the FFDCA. In 1969, President Nixon ordered a review of the safety of GRAS substances and their safety was reviewed for about 10 years from 1972. For substances not on the GRAS list, the GRAS petition (affirmation) system, which involved safety evaluation by the FDA, was operated, but the shortcomings (the long time required and the costs of having the petition approved) were supplemented by converting to the GRAS notification system. The GRAS notification system has been applied since 1997. Notification occurs when the applicant prepares and submits all data and results on the safety of the substance are accepted. Since the system’s introduction, as of December 2020, 937 new food ingredients have been examined, of which 736 were added to the GRAS list. There were 209 newly notified items added to the GRAS list between 2016 and 2020, 26 of which were microorganisms . Of thesIn Korea, a positive list system (PLS) was introduced and operated from 2016 to provide a list of food ingredients permissible for consumption. A list of microbial raw materials available as food was provided with the introduction of the PLS. However, the list of microorganisms was based on lists of microorganisms used in other countries, so there is a lack of consideration of food microorganisms involved in traditional fermented foods of Korea.In Korea, common fermented foods include fermented vegetables such as kimchi, foods made with fermented beans such as soybean paste, and fermented fish , 20. MosEnterococcus, Staphylococcus, and Tetragenococcus halophilus have been reported, alongside members of the genus Bacillus [Bacillus [23B. subtilis. However, with the recent development of analytical techniques, B. subtilis has been divided into B. amyloliquefaciens subsp. amyloliquefaciens, B. velezensis, or B. siamensis [Research on microbial communities in traditional fermented foods has been particularly focused on kimchi, which is produced by the application of starter bacteria. Although the definition of a starter is not clear, a list of lactic acid bacteria involved in the fermentation of dairy products was included in the aforementioned PLS, so these microorganisms can be used as food raw materials. Research on fermented beans has also been conducted actively in recent years, and many results have been obtained from Korea, China, and Japan. Doenjang, soybean paste made using meju, is a high-salt fermented food and salt-resistant bacteria are often predominant in it. Based on recent microbial community analysis of soybean paste through culture-dependent and non-culture-dependent methods, the relationships to the fermentation of bacteria such as Bacillus -23. Unlicillus 23. A repreiamensis . B. siamTo be registered as a new food ingredient, relevant documents must be submitted according to the recognition standards for temporary food raw materials (Notification of the Ministry of Food and Drug Safety No. 2020-110). Toxicity test and intake evaluation data must be provided for evaluation; the former must be produced by a Good Laboratory Practice institution, and the experiments are expensive. In the evaluation for the European QPS system, toxicity evaluation data are not required because qualifying organisms have a long history of intake and there is also a large body of knowledge about them. Therefore, compared with the QPS system, the microbial safety evaluation system in Korea is burdened by difficult procedures and high costs.The dominant bacteria in traditional fermented foods have been documented scientifically on a continual basis, but the application of microorganisms to a species is not easily done. Kimchi is a fermented food produced by lactic acid bacteria, and many of the relevant lactic acid bacteria are registered in Korea as food raw materials. However, microorganisms that are not registered as food raw materials must be registered as temporary food raw materials after a high-cost toxicity evaluation has been conducted.Bacillus have been studied more as plant protection bacteria than as microbes involved in food fermentation. Despite this, in East Asian countries, including Korea, Bacillus species are microorganisms involved in fermenting soybean products such as soybean paste, and are valued as starter candidates. Therefore, simplified procedures are needed for commercial starter candidates that have long been consumed in fermented foods. Recently, a coagulase-negative Staphylococcus strain was isolated from traditional fermented food but its application is not allowed because it is not registered as a food raw material with the Ministry of Food and Drug Safety. Instead, the strain is a fermented meat species and has a history of overseas use, so it can be used only for fermented meat. In this way, if the use of Korea’s fermented food-derived microorganisms is not possible in Korea due to not having a record of use overseas, it will be difficult to develop or secure novel microbial materials. Therefore, it is necessary to systematically support the application of microorganisms involved in the industrial production of traditional fermented foods in Korea, to enable their broader use.Most of the registered microbes among Korea’s food raw materials are those that are also registered as safe in other countries. However, microorganisms involved in fermentation are diverse depending on the raw material and the manufacturing method of the food, so it is not appropriate to compare the microorganisms involved in the traditional fermented foods of Korea with those of other countries. In Europe, members of the genus It is desirable to establish a safety evaluation system in Korea in which food ingredients can be registered as safe if there is sufficient information regarding their long-term intake and use in fermented foods containing a dominant species. In addition, even if a microorganism cannot be registered as a food raw material at the species level, a safety system is required for use in for Korean-style food products. The safety evaluation system needs to approach the safety evaluation considering starter microorganisms, rather than direct ingestion of the microorganisms.The application of starters is necessary for the globalization of fermented foods and commercial production with uniform quality, and therefore, safety evaluation criteria for starters are required as is evaluation of their functional characteristics. In Europe, the QPS system is a species-level safety evaluation system, and the Novel Food System is a strain-level system. It is also necessary to establish a safety evaluation system in Korea in which species and strains are separated.


Vocational rehabilitation may affect the frequency of health care use by improving the access or reducing the need for health care. We examined whether participation in rehabilitation effects the healthcare services use. Register-based data was utilized on all individuals aged 15–60 living in the city of Oulu, Finland, who started vocational rehabilitation in 2014–2015 (N = 784). We examined the use of outpatient health care services from 1.5 years before to 1.5 years after the start of rehabilitation and 1.5 years after the end of rehabilitation, and compared it to the propensity score matched controls. Rehabilitees had on average 1.5 visits to outpatient health care services in the 6th quarter before the start of rehabilitation. In the 4th quarter before the start of rehabilitation, that number increased to 1.8. After the rehabilitation period, the quarterly number of visits returned to the same level as at the beginning of the follow-up. The biggest changes were in the use of occupational health services. Compared to the propensity score matched controls, vocational rehabilitation did not appear to affect the use of health care services. Vocational rehabilitation seems to replace need for other services but not to affect the need to receive treatment for the underlying disease. The main target of vocational rehabilitation is the promotion of employment . There iIn addition to official goals such as promoting return to work , it is vAlthough a separate service from health care, vocational rehabilitation can affect the use of health services as a by-product of rehabilitation. On one hand, vocational rehabilitation can increase the use of health services in the long run. Work ability problems are often indicative of health problems, and vocational rehabilitation could improve access to health care. This may be due for example to guidance or increased awareness of services. On the other hand, vocational rehabilitation can reduce the use of health services during rehabilitation if it is employed as an alternative to efforts aimed at solving existing work capacity problems through health services. This indirect reducing effect may also appear over the long term if vocational rehabilitation helps to reduce the need for health service use. These possible effects can be viewed as positive if they reflect increased early support for individuals or lower burden on service capacity. To our knowledge, there is no previous research on the relationship between vocational rehabilitation and the use of health services.To study the effect of rehabilitation, a proper control group for rehabilitees is needed. Because rehabilitees are a highly selected group, it is not useful to compare them to the general population . Due to The aim of vocational rehabilitation is to improve the ability to work or study and to prevent prolonged disability or transition to disability pension. It is targeted to those who have an illness or impairment limiting work or study and who are assessed as likely to benefit from rehabilitation, both to those in and outside of working life.Vocational rehabilitation is based on an individual plan with a set of defined goals. It consists of various types of rehabilitation such as work and training tryouts, guidance and counselling, education, and training. The duration of rehabilitation may vary from a rehabilitation assessment lasting just a few days to a course of education lasting several years. The most common diagnostic groups causing occupational disability are musculoskeletal and mental disorders, which account for almost 80% of the cases ,8. Most There are two main organizers of vocational rehabilitation in Finland: the earnings-related pension system and the national pensions system administered by the Social Insurance Institution of Finland (Kela). Vocational rehabilitation available through the earnings-related pension system is targeted to those who are integrated into working life. Kela provides vocational rehabilitation for people who have been outside working life for a long time or have just recently or not yet entered the labour market.Among employees, undergoing vocational rehabilitation has been more common among women, older age groups, and persons with a lower socioeconomic position, as well as those with previous sickness absence ,10. LoweFinland has a three-sector health care system, where employment status affects the availability of health care . IndividAdditionally, factors related to individual characteristics, for example health and personal barriers such as perceptions of need, attitudes, beliefs and previous experiences with health services, are associated with the use of health care services . Thus, mVocational rehabilitation is a separate service from health services and is therefore not always seamlessly connected to them. This study examines the transition phase between rehabilitation and health services. To our knowledge, no prior study of that topic exists.The aims of the study are to examinetime after the start of the rehabilitationtime after the end of the rehabilitationHow the frequency of health care services use develops from time before the vocational rehabilitation toWhether vocational rehabilitation has an effect on the use of health care servicesWe used a large individual-level register-based dataset of all inhabitants living in Oulu, Finland, in the years 2013–2018 .Our intervention group included all those who started a vocational rehabilitation period organized by the national pensions or earnings-related pension system between July 2014 and December 2015. We selected the first rehabilitation period and combined successive episodes.n = 111).We restricted our analysis to persons 15–60 years old at the end of the year preceding their first spell of vocational rehabilitation. Persons 16 years old are entitled to occupational rehabilitation. The upper age limit was set so that the rehabilitees would not reach the lowest limit of old-age pension in Finland (63 years) during the follow-up. Over 98% of rehabilitees belonged to 15–60 age span. We excluded individuals whose health care use could not be followed for the whole 18-month period after rehabilitation  for 3 separate 18-month (1.5 years) periods: 6 quarters before rehabilitation, 6 quarters after the start of rehabilitation, and 6 quarters after the end of rehabilitation. Because it was not possible to count reliably the number of visits during the same day, we calculated the number of attendance days for each subject as a proxy for the number of visits.The outpatient health care services included visits in public primary health care (source of data: registers of the city of Oulu), in occupational health care , in private health care , in public specialized care , and emergency visits (registers of the city of Oulu and Hilmo). We examined them separately and in the aggregate.Individuals’ background factors before vocational rehabilitation were used for matching. These factors were obtained from the registers of Statistics Finland, the Finnish Centre for Pensions and the Social Insurance Institution of Finland. We included sex, age in 5-year age groups, education , main type of activity  and marital status  at the end of the previous year, and income quintiles from the previous year. Employment, unemployment and sickness absence days were calculated 0–6, 6–12 and 12–18 months before the start of rehabilitation. Dummy variables (yes/no) for permanent or temporary disability pension and for entitlement to special reimbursement for medicine expenses were counted 0–12 months before the start of rehabilitation. Data on special reimbursements is available for medicines used in the treatment of severe and long-term diseases, indicating a chronic disease .We used propensity score matching ,24,25,26In descriptive analysis, we examined the average number of visits in outpatient health care services quarterly in each three-month period between (1) 18 months before and after the start of rehabilitation and (2) 18 months before the start of rehabilitation and 18 months after the end of rehabilitation. We analysed rehabilitees separately for outpatient visits in public primary care, occupational health care, private health care, specialized care, emergency, and all outpatient visits combined.We also compared the use of combined outpatient health care services between rehabilitees and their matched and unmatched controls.After matching, we used difference in difference (DID) analysis to measure the differences, between the rehabilitees and their matched controls, in the temporal changes that occur in the use of outpatient health care over time. We modelled the number of outpatient visits with a regression model and compared the average number of visits in quarters 1–2, 1–4 and 1–6 before and after the rehabilitation to study the effect of rehabilitation on the use of health care.The background factors of rehabilitees, their matched controls and unmatched controls are described in After matching, the distribution of background factors was more similar between rehabilitees and their matched controls. Almost all variables reached the required level of similarity (the standardized difference being <10%). Still, some differences remained. Compared to their matched controls, rehabilitees were more often employed and had more employment days before rehabilitation and more sickness absence days 0–6 months before rehabilitation.The quarterly numbers of visits in different health care services before rehabilitation compared to (a) after the start of rehabilitation and (b) after the end of rehabilitation among those who participated in vocational rehabilitation are represented in The biggest changes took place in the use of occupational health services. The number of occupational health care visits increased steadily before the start of rehabilitation. After the start of rehabilitation (a), the number of visits temporarily decreased. At the end of the rehabilitation (b), the number of visits was first slightly higher but decreased then to the same level as at the beginning of the follow-up. Changes were modest in public health care services. In other services changes were minimal.After the start of rehabilitation (a), the number of visits among rehabilitees decreased slightly faster than among matched controls, but rose to a higher level than among the controls in quarters 5–6. After the end of rehabilitation (b), rehabilitees had slightly more visits than the controls. The quarterly number of visits returned to the same level as at the beginning of the follow-up.The use of health services remained clearly higher than in the rest of the population throughout the follow-up period.Comparing the numbers in the first and second quarters before and after rehabilitation, the average number of visits in outpatient health care services was greater before than after rehabilitation for both rehabilitees and their controls . The difIn sensitivity analysis, controlling for the starting year of rehabilitation and the employment days before rehabilitation, which we could not properly match, did not change the DIDs. Only the confidence intervals narrowed slightly.The pattern of health care service use changed over the course of vocational rehabilitation. The use of health care services was most common before rehabilitation. The changes were mainly due to visits in occupational health care services. However, compared to the propensity score matched controls, vocational rehabilitation did not appear to have an effect on the use of health care services.Among rehabilitees, the use of health care services was most common during the year preceding vocational rehabilitation. An injury or illness that requires vocational rehabilitation often also causes a need to use health services. In addition, a doctor’s statement describing a need for rehabilitation because of an illness or impairment is required in order to be admitted into rehabilitation. This requirement may increase the number of visits. The use of health care services dropped to its lowest level during the year after the rehabilitation started, indicating that rehabilitation may replace need for health services.After the end of the rehabilitation, the use remained at a relatively steady level, the same level as at the beginning of the follow-up. Overall, the number of visits was at a clearly higher level than in the entire population. The reason may be follow-up visits related to rehabilitation, e.g., in occupational health care, or the fact that rehabilitees are unhealthier overall or that they know how to use health services. The purpose of vocational rehabilitation is to improve work ability and the employment outlook, not rehabilitate the illness per se. Thus, the underlying disease causing a need for rehabilitation may remain and require visits to health care even after vocational rehabilitation. In other words, vocational rehabilitation does not necessarily eliminate the illness or impairment that causes work incapacity, but it can reduce its detrimental effects.Finland’s three-sector health care system also affects the use of health care services over the course of the rehabilitation process. Among the services examined in this study, the biggest changes in the number of visits was seen in occupational health care services. Occupational health care plays a key role in maintaining and promoting employees’ work ability. The most important tasks of occupational health care in relation to rehabilitation are finding out the need for rehabilitation, providing timely guidance for treatment and rehabilitation, and monitoring the ability to cope at work after rehabilitation. The Occupational Health Care Act directs the relevant actors to support work ability at the early stages and to work in close cooperation between the workplace and the occupational health care provider. Unemployed persons and others outside the working life mostly do not have access to occupational health care services, or health services of similar quality and accessibility. Thus, the use of public health services plays a particularly large role among the unemployed . The tasRehabilitees had a smaller decrease in the number of visits than their matched controls when we compared the total number of visits before and after rehabilitation. The smaller decrease among rehabilitees may be due to the fact that rehabilitees have been able to learn to use health care services during the rehabilitation process. This may even be desirable, as unmet need of health services, which is common in certain groups , may leaThe consistent finding of previous studies is that rehabilitees have a higher incidence of illness than the rest of the population, which is natural considering whom the rehabilitation is intended for ,10. In FOur study is one of the first to examine occupational rehabilitations’ possible effect on health care use. The main strength of our study was the individual-level register-based data with total population coverage in one city. We were able to cover the whole vocational rehabilitation system, including both the national pension and the earnings-related pension scheme. Previous studies have included only one of these. Our data contained detailed information on the use of health care services. We even had the data for occupational health care services, which is usually not covered by registers. Previous studies on health care services use have mainly used survey data, which is less reliable than register-based data. We also had several background variables for propensity score matching, especially socioeconomic factors and the level of health care use. We managed to find controls for rehabilitees with propensity score matching, with the exception of employment days. However, controlling for employment days in regression models did not affect the results. Because the right to vocational rehabilitation is statutory under the national pensions system, a randomized controlled trial is usually not possible. People cannot be divided into two groups, one of which would receive rehabilitation and the other would not.A limitation was that the slightly small number of rehabilitees (N = 784), despite that we had all rehabilitees in one city, did not allow any detailed analysis, such as by sex, age group or employment status. However, we were able to consider these in matching. There may also be variation in the need for health care services depending on the diagnosis of rehabilitation. Similarly because of a limited sample size, we had to summarize all different types of vocational rehabilitation, such as work and training tryouts, guidance and counselling, education, or training. However, there may be overlap in the different types of vocational rehabilitation, and it may be random as to which vocational rehabilitation an individual is directed to. In addition, the duration of rehabilitation varied widely, and we could not control for that effect. However, the effect of rehabilitation is not necessarily related to its length. Even short-term rehabilitation can be effective. Further, our data did not include the reasons for outpatient health care visits, which may have differed between the rehabilitees and the controls. Better nationwide registers of health care services use would enable analysis that is more detailed. Because of the data limitations, we excluded individuals whose health care use could not be followed for the whole period after rehabilitation. This might have resulted in an underrepresentation of long rehabilitation periods. We do not assume that it affected the results. It is difficult to compare our findings on the distribution of participants in rehabilitation with previous studies, because they only examined rehabilitation organized by one of the parties, either the national pension or the earnings-related pension scheme ,10. FutuThe pattern of health care service use changes over the course of vocational rehabilitation. The changes are mainly due to visits in occupational health care services. The use of health care services is most common around a year before rehabilitation. However, vocational rehabilitation does not appear to have an effect on the use of outpatient health care services. Vocational rehabilitation does not seem to affect the need for treatment of the disease underlying the rehabilitation, at least not yet in this time frame.Occupational health care seems to be the only service that is connected with the vocational rehabilitation process. For those that do not have access to occupational health care, and rely on public health services, the follow-up in health care services before and after vocational rehabilitation does not seem to be as good.Since the effects of rehabilitation on health care use may be different in different groups, further studies should examine services separately for different age groups and for those employed and those outside the working life, and should distinguish between different types of rehabilitation and diagnoses. That is possible only with proper register-based data. Policies should focus on providing better health care services for the non-employed and improving co-operation between different services.


Food is an integral part of human culture. Aside from its nutritional role, it connects us on a daily basis through the act of sitting and eating together, it contributes to feelings of shared identity in populations, it is an essential component of many formative events in our lives, and is a gateway to experiencing new cultures.While the influence of food in defining human culture is well-understood, there is a growing appreciation of the role of microbial cultures in defining the properties of food. Archaeological evidence points to the use of fermentation over many thousands of years for the production of a range of foods and beverages. Fermentation serves to make foods more digestible, longer-lasting, safer, and more palatable. For our species, the role of fermentation in food production has arguably been as influential as the role of fire for cooking food.For much of our history, these fermentation processes have been carried out by complex assemblages of organisms, with the use of single strains for fermentation of bread, beer, wine, etc. being a relatively recent development. We have however been seeing a growing interest in the use of microbial communities in food production. In the western world, this revival has been driven in part by the popularity of craft beer, natural wine, fermented non-alcoholic beverages , and sourdough bread. In other parts of the world, complex cultures in fermentation represent continuation of tradition rather than revival.This Research Topic from Frontiers in Microbiology aims to highlight the beneficial role of microbial complexity in driving fermentation processes and influencing food quality. The issue features ten articles describing investigations into complex microbial fermentation for the production of food, feed, and beverages. Contributions were received from Africa, Asia, Australia, Europe, and South America—highlighting the global importance of fermentation. Demonstrated benefits of particular communities during fermentation include improved flavor and color, greater safety, increased nutritional value, faster fermentation rates, reduced alcohol content, and better industrial applicability.Elhalis et al., who show improved sensory properties of coffee after fermentation with the yeast Pichia Kudriavzevii. Likewise, Köhler et al. note how specific yeast and bacteria combinations can improve the flavor of water kefir. Liu et al. describe the relationship between bacterial composition and flavor profile of Xifeng liquor (a spirit prepared from fermented sorghum).One of the most direct impacts of fermentation is the creation of specific flavor profiles. We see this in the work of Su et al. for example, note how fermentation of corn by-products with Saccharomyces yeast and lactic acid bacteria can improve their suitability for use as feed. Dahunsi et al. provide a comprehensive account of how the presence of lactic acid bacteria within fermentative microbial consortia have a critical role in ensuring the safety and shelf-life of many fermented African foods. Likewise, Huang et al. describe the metabolites produced by the yeast Debaryomyces hansenii can prevent the growth of contaminant molds during Danish cheese production.Palatability of foods is not the only factor influenced by fermentation. Benefits extend also to improved digestibility and safety. Martinez et al. who describe how coffee fermentation is influenced by altitude, and how this is associated with changes in the natural microbiota. Substrate also influences the development of populations, as illustrated by Liu et al. who show how different microbial communities develop depending on the type of sorghum used in Xifeng liquour production. Su et al. likewise show how communities develop differently in different by-products of the corn starch industry. These, and other studies described in this Research Topic, demonstrate the power of high-throughput sequencing in studying microbial communities. This is particularly important for dynamic, complex or under-researched communities. This is exemplified in the studies on dark tea fermentation by Yan et al. or the work of Atter et al. on Ghanian cereal fermentation.The composition of species in a fermenting culture is strongly impacted by the environment, a fact that must be considered when trying to control or direct fermentation processes. The effect of environment is clearly seen in the study of Huang et al. coffee fermentation by Elhalis et al. and water kefir production by Köhler et al.Despite the advantages of complex fermentations with respect to product quality, it should be noted that industrial application of such cultures is not without complications. More complexity may lead to less consistency in fermentation processes. The controlled use of cultures, e.g., supplementing natural microbial consortia with specific species, or rationalizing consortia so that they contain only the keystone species, represents a compromise in this respect. Examples are seen here in the work on cheese production by Complex fermentations demonstrate great potential for improving food process efficiency, enhancing food quality, and increasing diversity of available foods and beverages. It is clear however that our ability to fully exploit such fermentations is limited by insufficient knowledge of how individuals in mixed populations interact to influence each other and their environment. It is our hope that this Research Topic represents a step forward in our understanding of these complex systems, and will to some extent facilitate the efficient production of a range of high quality food products in the future.All authors listed have made a substantial, direct, and intellectual contribution to the work and approved it for publication.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.