Preparing Students for Medical Device Innovation: Notes from BME-IDEA 2018

On Wednesday, October 17, 2018, I attended the BME-IDEA (Biomedical Engineering Innovation, Design, and Entrepreneurship Alliance) meeting in Atlanta, GA, USA. It was the 12th convening of this meeting which was first held in 2003 and precedes the annual BME Society meeting on alternate years. BME-IDEA provides a forum for faculty teaching BME design, innovation, and entrepreneurship to share best practices in training inventors and innovators, discuss common challenges, and create new initiatives in BME design education. The goals of the meeting were to:

  • review the experiences of the diverse community of university programs involved in innovation, design, technology transfer, and entrepreneurship in BME education;
  • discuss objectives, challenges, and opportunities for further development of these programs, including industry and academic perspectives;
  • explore the potential for sharing resources and facilitate the creation of community-wide resources and tools.

This year’s meeting included sessions on industry–academia partnerships, healthcare economics, expanding teams beyond BME, diversity in BME innovation education, global innovation education, and several large and small group breakout sessions covering a variety of topics such as reimagining the future of BME design competitions and BME clinical immersion programs for design teams. The following is a summary of a selection of these sessions along with some helpful ideas for how to better prepare students to become medical device innovators.

Strengthening academic partnerships in developing high potential talent and solutions

In this session, panelists from Johnson & Johnson, Avanos Medical, Abbott Laboratories, and Medtronic provided an industry perspective on what faculty can do to better prepare students for careers in industry. Recommendations included helping students develop an understanding of: 1) hospital reimbursement for medical devices; 2) hospital purchasing procedures; and 3) other business aspects of the medical device industry. It was suggested that case studies be created, with participation from industry stakeholders, and used to present these topics to students. Another novel suggestion was to create “field travel days” that would be used for a sales immersion experience to help students understand how medical devices are marketed and sold and the challenges in understanding customer needs in the field.

When asked about the importance of additional education in preparing students for employment with device companies, panel members felt that experience was more important than an advanced degree. To maintain a relevant curriculum, they suggested that faculty speak with their alumni and ask entry-level engineers what would have been helpful for them to have learned during their undergraduate (or graduate) programs to better prepare them for careers in industry.

Essentially complicated: Making sense of healthcare economics

Healthcare economics play an important role in the design and adoption of new medical technologies. Engineers need to understand how financial and economic issues can impact medical device design and innovation. In this session, academic economists and industry decision makers provided their perspectives on what our students (as future inventors and innovators) should know about healthcare economics.

Panelists agreed that in the current economic environment, there is more of a focus on value and less on cost. They shared a few observations that reflected this current focus.

  • Many new technologies do not decrease cost, nor do they increase the quality of care.
  • Current slower growth rates of Medicare spending are related to a decrease in medical technology innovation.
  • There is a connection between clinical outcomes and Medicare payments; value-based contracts tie reimbursement to outcomes and this is increasingly influencing decisions and choices in the entire continuum of care.
  • Products that can improve compliance, prevent readmissions, and keep patients out of the hospital are important to increase value and can lower costs. Hospitals may be resistant to these new technologies due to the potential impact on revenue presenting a quandary for innovators.
  • Products that reduce adverse events can reduce costs. Students should be trained to calculate these costs and to determine the economic impact of fewer adverse events and lower hospital readmission rates on design decisions.

The panelists suggested that students need to become familiar with: 1) Medicare reimbursement; 2) the value of products that can save time, improve safety, improve compliance, and reduce adverse events to customers; and 3) how to determine and communicate a product’s value proposition.

Clinically connected: BME immersion programs for design teams

In this session, faculty from eight universities shared challenges, strategies and best practices, and helpful resources related to clinical immersion experiences.

Challenges

  • Scaling up from a small number of students to a larger group so that all students can benefit from clinical experiences. This can present a significant challenge due to required student paperwork (proof of immunizations, medical test results, and other required documentation), conflicts with student class schedules, and transportation issues.
  • Assessing course or clinical immersion program outcomes.
  • Obtaining “buy-in” from clinical personnel. Finding cooperative clinicians willing to sponsor students and provide shadowing experiences was identified as an issue for schools without a local medical school.
  • Using unmet needs identified during clinical immersion experiences to create senior design projects. Screening for appropriate scope and avoiding “surgeon bias” toward a specific design solution are necessary to ensure meaningful design project experiences.

One session participant stated that it is a privilege for students to be able to observe procedures in the clinical environment and that not all students are deserving or mature enough to earn this privilege. He suggested screening students to ensure that only deserving and mature students participate in clinical immersion experiences.

Strategies and best practices

  • Goals of clinical immersion/observation courses included needs finding, understanding clinician and stakeholder perspectives, finding clinical mentors and advisors for design projects, and developing clinical literacy through observing procedures in a variety of diverse clinical settings.
  • Assessment strategies/criteria included using pre/post surveys, determining the quality of identified needs, evaluating project pitches by reviewers from industry, determining the quantity of needs that result in actual design projects, and using clinical experience reports to record and report what was observed and document potential unmet needs.
  • Clinical orientation and student preparation strategies involved several approaches. First, interviewing students to assess and predict required level of maturity and appropriate behavior in the clinical environment was found to be helpful. Second, requiring students to attend a clinical orientation session that discusses topics such as operating room (OR) etiquette, patient privacy, roles of OR personnel, where to stand in the OR, what OR visitors can/ cannot do, and what to do if a student feels faint or nauseated is helpful in preparing students for a safe, productive, and beneficial clinical experience. Third, teaching students how to observe, listen, ask thoughtful questions, and document what they see and hear has been done through guest speakers from industry who discussed ethnographic methods used by engineers in the design of new medical devices. Finally, to help students understand the terms they may hear while in the clinical environment, exams on medical and anatomical terminology have been used successfully.

Other best practices included use of guest speakers to provide diverse perspectives of: 1) medical technologies from various medical personnel (surgeons, physicians, nurses, physical therapists, dentists, clinical engineers, etc.) and 2) unmet needs of various client groups (developing nations, people with disabilities, home healthcare patients, etc.). Setting expectations among students and clinical collaborators that not all unmet needs identified will result in design projects was recommended to avoid jeopardizing collaborative relationships with clinicians.

Helpful resources

These include the creation and/or sharing of:

  • videos illustrating how to identify an unmet need;
  • exams on medical terminology;
  • clinical orientation presentations.

Several participants discussed the value of using simulation labs to allow students to experience performing procedures involving medical devices (such as a Foley catheter insertion) on simulation mannequins or virtual simulators. These can be very helpful to students in understanding problems with medical devices but would be a difficult resource to share among students from different institutions.

The BME-IDEA meeting provided a forum for more than 100 attendees from industry and academia to share perspectives and ideas for how to improve BME design and innovation. For additional opportunities to learn more about design, innovation, and entrepreneurship, see the accompanying sidebar for information on the upcoming VentureWell OPEN conference from 28–30 March 2019 in Washington, DC, USA. Attendees from across the innovation and entrepreneurship spectrum will meet to share knowledge, start new collaborations, and learn emerging best practices in the rapidly evolving field of technology entrepreneurship education.

Acknowledgments

Thank you to Dr. Sarah Rooney of the University of Delaware for sharing her notes on the clinical immersion breakout session.

Reference

  1. BME-IDEA Program Book, Atlanta, GA, USA, 2018.