- Email: [email protected]
Educating Innovators of Medical Technologies
CHAPTER 20
Educating Innovators of Medical Technologies William K. Durfee1 and Paul A. Iaizzo2 1
Department of Mechanical Engineering, University of Minnesota, Minneapolis, MN, United States Department of Surgery, Institute for Engineering in Medicine, University of Minnesota, Minneapolis, MN, United States
2
20.1 INTRODUCTION Learning to be an innovator in medical technologies has many similarities to innovating in other technology areas. At the same time, medical technology has unique features that can make it more challenging to transfer what is learned about innovation into another space, such as consumer electronics. For example, medical technologies are highly regulated, so a strong knowledge of continually changing regulatory pathways is needed. Some medical devices are expensive and sales of such devices will only occur if the cost is reimbursed by third party payers; therefore, knowledge of effective reimbursement strategies is also required. Because successful medical devices must have clear evidence of outcome effectiveness, the innovator must know how to conduct a clinical trial and perform post-market surveillance. Further, a medical technology must be adopted by practicing clinicians, so the innovator must understand the clinical environment, knowledge that cannot be gained from only reading, but rather by immersion in the clinic. This chapter describes various methods for educating the next generation of medical technology innovators and for continuing the education of current innovators who wish to stay up-to-date. Some of these opportunities occur within undergraduate and graduate programs at universities around the world and thus are targeted toward degree-seeking students. Other education programs are developed for working professionals who are looking to transition into the medical technology sector from an associated or completely unrelated field. Still other methods focus on clinicians who wish to become clinician innovators and become substantially involved in developing new medical devices that solve the problems they experience every day within their practices. Still other programs occur in large medical device companies that are seeking to keep their employees up-to-date. The medical device education programs described in this chapter are only part of what it takes to educate an ultimately successful innovator, as much of the responsibility rests with the lifelong learner. To start, one must become familiar with relevant Engineering in Medicine DOI: https://doi.org/10.1016/B978-0-12-813068-1.00020-8
r 2019 Elsevier Inc. All rights reserved.
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medical literature, first studying textbooks, then adding literature reviews and specific journal articles that cover the anatomy, physiology, diseases, and therapies related to the area of interest. The expert innovator must have skills in searching PubMed for relevant articles as well as the United States Patent and Trademark Office site for patents.
20.2 UNIVERSITY COURSES AND DEGREE PROGRAMS For many engineering and business students, an introduction to the medical technology development process comes through undergraduate or graduate design or business analysis courses. Others choose to learn these processes through a postgraduate professional degree program that covers one or more specific areas of medical technology. This section provides a few examples of potential courses and programs.
20.2.1 Engineering design courses Worldwide, nearly all accredited undergraduate engineering programs culminate in a required capstone course, where students apply what they have learned in classes. In the typical capstone course, a team of students works on a design project for a client over the course of a 15-week semester. While most of the course consists of project work, the didactic portions of such training typically cover the design process, and many include lectures on needs finding, ideation, prototyping, patents, writing and presenting, and project management, among other topics. A typical example is ME4054 Design Projects, the capstone course for students in the Department of Mechanical Engineering at the University of Minnesota, where many of the projects are medically related. A few examples of previous projects in this course include an adjustable length tracheostomy tube for Smiths Medical, a cable-driven hand orthosis for Abilitech Medical, and an intracranial targeting guide for the Department of Neurosurgery, University of Minnesota. Typically, project mentors from the client organization also participate to provide students with real-world training in the relevant aspects of medical technology development. Several universities also have developed design courses that focus exclusively on medical technologies, with the didactic portion guiding students through a condensed need finding, concept creation, and prototype build and test process. Examples include BMEN 4001/4002, the two-semester capstone design sequence in the Department of Biomedical Engineering at the University of Minnesota, 2.75 Medical Device Design at Massachusetts Institute of Technology, MENG/BENG 404 Medical Device Design & Innovation at Yale University, BME 4050C Medical Device Design at the University of Cincinnati, ME 294 Medical Device Design at Stanford, and BIOE 451/452 at Rice University, among many others.
Educating Innovators of Medical Technologies
20.2.2 Business analysis courses Still other university programs available for the beginning innovator focus on analyzing the associated business opportunity for medical technologies. An example is the Medical Industry Valuation Lab, part of the Medical Industry Leadership Institute within the Carlson School of Management at the University of Minnesota.1 The Valuation Lab provides industry innovators with a rapid, comprehensive business analysis of their proposed medical innovation and its prospects in current and projected markets. Teams of graduate students from the Carlson School of Management, College of Liberal Arts, College of Science and Engineering, Law School, and the Academic Health Center conduct these analyses, taking on three projects over the semester. Each project is a rapid, 5-week market assessment that examines intellectual property, market size, regulatory path, reimbursement strategy, and financial return. Importantly, the students and faculty mentors sign a nondisclosure agreement with companies, so that confidential information about the innovation can be freely exchanged. Typically, the analytical results are provided to the client in a 15-page business analysis document as well as an in-person presentation, where the critical findings are delivered and discussed. Importantly for the success of this training program, clients come from large and small companies from Minnesota and around the world. In addition, the Valuation Lab routinely assesses the potential commercial viability of medical technologies created in various University of Minnesota research labs. Recently, the Valuation Lab examined a new way of measuring muscle strength and fatigue in children with muscular dystrophy. University on Minnesota investigators had developed a novel, low-cost prototype device that allowed for accurate measurements while motivating the user to exert maximal voluntary muscle force. The Valuation Lab team studied clinical literature related to muscular dystrophy, interviewed neurologists, physical therapists, and clinical care coordinators, examined regulatory and reimbursement paths, conducted a preliminary patent search to establish freedom-to-operate, determined market size, and created pro forma financials with probable income and expenses should a business be formed around the product. Importantly, the team ultimately recommended against further investment in the innovation due to the small market, yet pointed out a possible avenue for licensing the associated technology and/or associated testing procedures.
20.2.3 Degree programs Along with individual courses, some universities offer degree programs specifically related to medical technology innovation. One example, targeted at working professionals, is the Master of Science in Medical Device Innovation, a 14-month program led by professionals from medical technology industry, and part of the Technological
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Leadership Institute at the University of Minnesota. Other examples include the Regulatory Affairs and Services Masters program at St. Cloud State University in Minnesota, and the PhD and Masters programs offered by the Department of Regulatory and Quality Sciences at the University of Southern California. The number of these programs is growing, thus medical device innovators who want to hone their skills should identify locally available degree programs, some that can even be completed through remote learning.
20.2.4 Medical device design and development courses While some courses in medical device innovation have an engineering design focus and others emphasize business development, a few universities have uniquely developed comprehensive courses that combine both elements. One example is the graduate-level, two-semester New Product Design and Business Development (NPDBD) course offered by the College of Science and Engineering and the Carlson School of Management at the University of Minnesota.2,3 For over 20 years, this multidisciplinary, experiential course has engaged students in the product development and entrepreneurial process. NPDBD connects leading medical device companies with University of Minnesota graduate students from different disciplines to develop valuable new products. Throughout a 9-month project cycle, each client company sponsors a team of engineering and business students in connection with a specific product. Drawing on guidance from their client, faculty coaches, industry advisors, and student teams works independently to conduct background research and to develop a working prototype and accompanying business plan, which the client then carries forward to launch. The primary aim of the course is to educate graduate students in the knowledge and skills required to commercialize a new product, including new medical devices. A secondary aim is to return value to the client company by moving their new product closer to launch. The learning objectives for students include the ability to work with engineering or science specialists and business management teams, the ability to define and achieve both short- and long-term technical and business goals, understanding the steps necessary to produce a viable product, and appreciating the difference between a plan on paper and the reality of a rapidly evolving technical product market. Each team consists of approximately six students (half engineering, half business), along with a faculty coach and various client company representatives, all working together over 9 months to develop a working prototype product and business plan for the client company. Products are real and are taken through launch by the sponsoring company. Each project addresses market feasibility (What is the need? Do customers want the product?), technical feasibility (engineering design, prototyping, and
Educating Innovators of Medical Technologies
manufacture), and financial feasibility (how much money the company will make). The overall NPDBD process can be summarized as follows: 1. Discover: Understand the context and explore the opportunity space. 2. Define: Define the customer need and state the problem. 3. Create: Create a solution to the need. 4. Deliver: Deliver on the solution. During the first semester, the team is focused on discovery, which includes these components: 1. Understand the context: Research the disease state, existing solutions, competing products, and relevant technology. Use secondary market research to define market trends. 2. Discover needs: Conduct customer interviews and develop a needs statement. Initiate a product requirements document. 3. Ideate: Create one or more concepts that satisfy the need. Execute a rough working prototype of each concept. 4. Assess: Conduct initial screen for market, technical, and financial feasibility. In the second semester, the team turns its attention to execution, including these steps: 1. Validate the concept: Gather customer reactions to the concept. Conduct preliminary engineering bench tests of the prototypes. Select the concept to execute. 2. Develop the concept: Finalize the detailed product requirements and engineering design. Fabricate, assemble, and bench test an alpha prototype. Gather customer reactions to the prototype. Create a manufacturing plan. Protect intellectual property. 3. Develop the business plan: Use the Canvas model to solidify the value proposition, customer segment, distribution channel, cost structure, and revenue stream. 4. Assess: Conduct final screen for market, technical, and financial feasibility. 5. Create hand-off plan for the client to continue execution. The NPDBD course meets once a week (attendance is required and expected) for lectures that cover the basics of the product development process. For example, students receive instruction in sketching, low-resolution prototyping, and patent searching, as well as how to define and research markets, how to gather primary market data through voice-of-the-customer observations and interviews, and how to financially value a new product or business. In addition, each team schedules two weekly team meetings. One team meeting includes the faculty coach and company representative (when available), with the purpose being to make decisions and set high-level direction. The second team meeting includes students only, with the intent to discuss results, work on documents, report progress, and create detailed plans. Each year, the course hosts six or seven projects; clients are often well-established companies that pay a sponsorship fee of $25,000. In some cases, clients are start-up
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companies or solo entrepreneurs that pay a lesser fee of $10,000. These fees support the extra administrative and instructional costs of running the course, as well as expenses for prototyping, supplies, and technical support. The clients and projects vary from year to year, depending on the companies involved and their specific product needs. A list of projects is provided to students on the first day of class, and team assignments are based on preference and an attempt to balance teams for equal business and engineering representation. The student team is a self-directed work group with leadership selected by the team, while the faculty coach is there to guide and mentor the team. Projects are completed in collaboration with the client, so the company representatives play an important role; it is essential that the goals and direction taken by the student team align with those of the company. Typically, this occurs through regular and thorough communication between students and company sponsors. One of the consequences of working on real projects for clients is that company sponsors have an interest in controlling the flow of information about the project and in determining who has ownership of new ideas. Therefore, all students and faculty in the course sign nondisclosure and intellectual property agreements with each of the sponsoring clients. The nondisclosure agreement enables the client to share confidential information with the student team, and the intellectual property agreement assigns patent ownership to the client for any inventions created by the students or faculty. One of the implications of the NPDBD nondisclosure and intellectual property agreements is that students cannot reveal any details about their project to friends, family members, or university experts outside the course from whom they seek advice. Also, while students will not own the patent on any invention resulting from the course, they will be named inventors on the patent. The language of these agreements used in NPDBD was the result of negotiations early in the course history between the Office of the General Counsel at the University of Minnesota and several early client companies. Because students sign agreements with all companies sponsoring a project in that year, information can be freely exchanged among teams during class lectures and presentations. Students have successfully worked on dozens of projects over the history of the NPDBD course; Table 20.1 lists projects for the past 5 years of the course.
20.3 WORKSHOPS AND SHORT COURSES There are also several workshops and short courses sponsored by universities, conferences, and trade organizations, targeting professionals who wish to become medical device innovators. Some have a relatively narrow focus. For example, each year the Institute for Engineering in Medicine (IEM) at the University of Minnesota offers two weeklong courses, one in advanced cardiac physiology and anatomy4 and the
Educating Innovators of Medical Technologies
Table 20.1 Sponsors and Projects of the New Product Design and Business Development Course, University of Minnesota (last 5 years) Year Sponsor Student team project
201617
201516
201415
201314
201213
IKC America Spinal Designs Agora Investment SelfEco 3VO Medical Medtronic Medtronic Medtronic Agora Investment Digital Design Studios IKC America University of Minnesota Medtronic Medtronic Borkon Shooting Lab YOXO CCEFP Medtronic EmbraSure Medical Tactile Medical Boread Medical Tech. Modiron Medical Devices Center GeneSegues Gromit & Bronk Medical Devices Center Medtronic Smiths Medical Smiths Medical Surgical Robotics Lab
Product to treat veterinary injuries Product to alleviate back pain New type of backpack Self-fertilizing planter for coffee beans Birthing aid Device for treating arterial lesions Device for transcatheter heart valve Sensor for cardiac ablation procedures New inline skate concept New way to treat bunions Product to treat athletic injuries New toothbrush Product for transcatheter aortic valve replacement Method to access heart for cath lab procedures Product related to women’s’ health Product for training basketball shooting skills New toy using recycled materials New applications for small hydraulics Monitoring system for cryoablation New way to tie the jaw shut Active compression garment Femoral artery access device Method for removing wrinkles from clothing Monitoring anesthesia motor block Skin patch for drug delivery Child stroller Ablation monitoring system iPad product information app Warming blanket Vascular access Surgical skills testing system
For complete project list, see www.npdbd.umn.edu. CCEFP, Center for Compact and Efficient Fluid Power.
other in the anatomy and physiology of the pelvis and urinary system. The cardiac course has been extremely popular for the past 19 years and was initially developed for cardiovascular device designers and managers, many of whom never had physiology or anatomy in college or graduate school. The course includes lectures on anatomy, cardiac performance, heart disease, surgical procedures, and cardiac devices, among other topics. The lectures are supplemented with hands-on cadaver gross anatomy labs in which students work in teams to dissect a human heart. Table 20.2 shows
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Table 20.2 Schedule for Cardiac Physiology and Anatomy Short Course (University of Minnesota) Monday
Welcome Course Introduction/General Review of the Cardiovascular System Cardiac Myocytes The Conduction System of the Heart 12-Lead ECG (Demonstration) LUNCH (provided) EKG Lab—Biopac Systems Control of Coronary Blood Flow during Normal and Disease States Thoracic Surface Anatomy and Great Vessels Gross Anatomy Lab 1: Thoracic Surface Anatomy, Subclavian Region and Great Vessels
Metzger Iaizzo
7:45 a.m. 8:00 a.m.
Barnett Iaizzo Howard
9:00 a.m. 10:00 a.m. 11:00 a.m. 121 p.m. 12:30 p.m.
VHL graduate students Katz Weinhaus Weinhaus/Cook/ Iaizzo
Keynote Presentation: “Resiliency: Excelling in a Tough Environment” Dr. Rosemary Kelly, Professor and Chief, Division of Cardiothoracic Surgery, University of Minnesota
1:30 p.m. 2:30 p.m. 3:00 p.m. 7:00 p.m.
Tuesday
Cardiac Development Mechanical Aspects of Cardiac Performance: Blood Pressure, Heart Tones, and Diagnoses Large Mammalian Comparative Cardiac Anatomy Cardiac Energy Metabolism LUNCH (provided) Use of Device-based Approaches to Treat Cardiovascular Diseases Associated with Increased Sympathetic Activity Congenital Cardiac Disease Surface Anatomy of Heart and Lungs Gross Anatomy Lab 2: Lungs, Great Vessels and Coronary Vessels
Martinsen Hutchins
8:00 a.m. 9:00 a.m.
Hill Iles
10:00 a.m. 11:00 a.m. 12:00 p.m. 1:00 p.m.
Osborn
MacIver Weinhaus Weinhaus/Cook/ Iaizzo
2:00 p.m. 3:00 p.m. 3:30 p.m.
Roukoz Laske Eggen Bateman
8:00 a.m. 9:00 a.m. 10:00 a.m. 11:00 a.m.
Raveendran
121 p.m. 1:00 p.m.
Wednesday
Catheter Ablation of Cardiac Arrhythmias 3D Electrophysiologic Cardiac Mapping Pacing and Defibrillation Valve Anatomy and Transcatheter Valves/ Minimally Invasive Valve Repair Procedures LUNCH (provided) Interventional Cardiology: Stents, Closure Devices, etc.
(Continued)
Educating Innovators of Medical Technologies
Table 20.2 (Continued)
The University of Minnesota: One of the Pioneering Institutions in the Field of Cardiovascular Surgery Internal Anatomy of the Heart and Posterior Mediastinum Gross Anatomy Lab 3: Internal Anatomy of the Heart and Posterior Mediastinum
Iaizzo
2:00 p.m.
Weinhaus
3:00 p.m.
Weinhaus/Cook/ Iaizzo
3:30 p.m.
Sivanandam Loushin Beilman Huddleston Weinhaus Weinhaus/Cook
8:00 a.m. 9:00 a.m. 10:00 a.m. 11:00 a.m. 121 p.m. 1:00 p.m. 1:30 p.m.
Iaizzo
1:30 p.m.
Metzger
8:00 a.m.
John Iaizzo
9:00 a.m. 10:00 a.m.
Liao
11:00 a.m.
Martin
121 p.m. 1:00 p.m.
Bateman
2:00 p.m.
Weinhaus/Cook/ Iaizzo
3:00 p.m.
Thursday
Introduction to Echocardiography Intro to Anesthesia for Cardiac Surgery Monitoring in the ICU Ex Vivo Perfusion of the Heart or Lungs LUNCH (provided) Clinical Anatomy (anatomy review) Gross Anatomy Lab 4: Clinical Anatomy (anatomy review) Small Group Demos: In vitro swine, fresh cadaver Friday
Experimental Gene Therapeutics for Heart and Muscle Ventricular Assist Device Therapy Novel Visualization of Functional Human Cardiac Anatomy Employing Visible Heart Methodologies Minimally Invasive Cardiac Surgery: Technique Overview LUNCH (provided) Patient Continuum of Care Following Cardiac Interventions Cardiac Anatomy Modeling, Virtual Reality, Virtual Prototyping and Atlas Website Tutorial Gross Anatomy Lab 5: Finish Dissections and “Grand Rounds”
a typical schedule for this course. This type of short course is an effective way to obtain academic training in a short, intense period. Other workshops cover the medical device innovation process. One example is the Academy of Innovation, a 1-day workshop held in conjunction with the annual International Conference for Innovations (ICI) meeting in Tel Aviv for interventional cardiologists and targeted to physicians who wish to become entrepreneurs and innovators. The workshop has three components: (1) didactic
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Figure 20.1 ICI Academy of Innovation. ICI, International Conference for Innovations.
lectures on medical technology innovation, including the innovation process, assessing needs, regulatory, patents, and other relevant topics; (2) war stories from seasoned medical technology entrepreneurs to contribute a real-world focus; and (3) hands-on ideation and prototyping so that, by the end of the day, every participant has invented a new medical device concept (Fig. 20.1, Table 20.3). The hands-on activities are a highlight of the workshop. In one activity, small groups are given a needs statement and asked to prototype a solution to the need, using only the limited supplies provided (paper clip, index card, tongue depressor, foil, clothes pin, and other similar items). The goal is to design a solution for a specific customer-based need and to experience the utility of low-resolution prototyping methods for communicating an idea. In another activity, the group comes up with a need, invents a medical technology that meets the need, and then builds a first prototype using a large “pile of junk” (miscellaneous) parts collected from surgery and procedure suites (catheters, tubes, syringes, valve delivery units, and surgical instruments) along with foam board, hot glue, and duct tape. ICI has hosted this workshop for 8 years and has trained hundreds of participants in the innovation process. A similar workshop was spun off and is offered as part of the annual Design of Medical Devices Conference in Minneapolis, Minnesota (http://www.dmd.umn.edu/).5,6 Additional workshops occur at the Transcatheter Cardiovascular Therapeutics (TCT) conference and other professional scientific sessions where innovation is emphasized. Still other workshops are organized by industry trade organizations. For example, Regulatory 101 is the most popular of many events hosted by Minnesota’s Medical Alley Association.7 This 1-day workshop provides a basic overview of the regulatory process then examines regulatory pathway topics such as pre-submission strategy, clinical trials under investigational device exemption, premarket approval submissions, and post-market surveillance. Invited speakers typically have real-world experience and come from regulatory consultancy firms and the regulatory divisions of medical technology companies.
Educating Innovators of Medical Technologies
Table 20.3 Agenda for the Academy of Innovation (1-day workshop on medical technology innovation, part of ICI meeting, Tel Aviv)
08:3008:50 08:5009:00 09:0009:20 09:2009:40 09:4010:00 10:0010:30 10:3011:00 11:0011:45 11:4512:05 12:0512:30 12:3013:10 13:1013:30 13:3013:50
13:5014:10 14:1014:30 14:3015:10 15:1015:30 15:3016:00 16:0016:20 16:2016:40 16:4017:15 17:15
Reshaping Medical Pipelines—How Clinicians are Becoming Innovators Perspective on Innovation Development within an Academic Medical Center How New Medical Products are Developed— Overview of New Product Development Process Essentials of Creativity—Sketching, Notebooks, and Documenting Brainstorming Warmup Testing Your Medical Device Idea: Bench Tests, Preclinical, Clinical Trials Networking Break Innovation Exercise 1: Generate Ideas Protecting your Intellectual Property through Patents Device Innovation: Role of Regulatory Requirements in the U.S. Lunch Inventing, Developing, and Commercializing New Medical Devices How to Determine if a New Device is Needed— Market Evaluation and Needs Assessment Methods The Corporate View of Technology Assessment and Acquisitions From an Idea to Exit—the Bumpy Road Today Innovation Exercise 2: Developing a New Cardiovascular Product Digital Health Revolution—A New Player in the Innovation Market Networking Break Team Presentations Fostering a Culture of Do-it-yourself Innovation Cardiovascular Medical Device Innovation: A Discussion Q&A Panel Adjourn
Lotan Beyar Durfee Iaizzo & Durfee Durfee Iaizzo
Durfee Oktay
Pardo Richardson
Laske Essinger
Fitzgerald
Cohn
20.4 INNOVATION FELLOWS PROGRAMS For early-career individuals who can commit to a year of full-time intensive training in medical technology innovation, fellowship programs offer a unique opportunity. Started by Stanford as part of their Biodesign program, there are now many variations of fellowships offered at universities around the world, including the University of
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Minnesota, Texas Medical Center and Rice University, Johns Hopkins University, Hebrew University, Indian Institute of Technology at Delhi, and others. One example is the Earl E. Bakken Medical Devices Center Innovation Fellows Program at the University of Minnesota, a full immersion education and product development program for medical device creation.6 Now in its 10thyear, the program has the primary goal of developing the next generation of entrepreneurial and intrapreneurial medical innovation leaders. Each year, eight fellows are selected in a competitive application process. Successful candidates are self-driven, motivated, embody an entrepreneurial spirit, and have an interest in medical devices. Preferred qualifications are an engineering or science PhD, a medical or health-related degree, a business degree, or substantial industry experiences. Typically, a fellowship class includes individuals that represent each of these categories. The program teaches fellows a disciplined innovation process of understanding clinical environments, finding and screening needs, and developing products and businesses that satisfy those needs. In Minnesota, there is a Phase 1 segment, which is an 8-week boot camp with intensive didactic lectures drawn from university and local medical technology community experts. Phase 2 of the fellowship program consists of 8 weeks of clinical immersion where fellows are inserted into local hospitals and clinics to directly observe procedures and interact with clinicians. The output of this phase is a set of filtered, significant need statements. Finally, there is Phase 3, product development, which is the bulk of the program where the fellows, working in small teams and on several projects, ideate concepts and take concepts through several cycles of buildinventvalidate, with the aim of creating new business opportunities that could be further pursued in a startup (for entrepreneurs) or within an established company (for intrapreneurs). Other fellows programs have similar goals and timelines. Across all of the fellows programs, many medical device startups have emerged, a testament to the effectiveness of this type of experiential education. A recent Minnesota fellows success story is Minne Ties, an innovative way of achieving maxilla-mandibular fixation to heal a jaw fracture (Fig. 20.2). The conventional method is to use metal wires which patients find uncomfortable; they additionally present a safety hazard for surgeons who must take care not to injure themselves or the patient with the sharp edges of cut wires. Alan Johnson, a 2012 Minnesota Innovation Fellow, saw the need while observing jaw fracture repair during the clinical immersion phase of the program. Johnson invented what is essentially a medical form of plastic tie wrap that contractors use to secure cable bundles. After many stages of prototyping and testing, Minne Ties emerged as a safe, simple, and efficient means of fixing the jaw. In 2017, the technology was licensed by Summit Medical (now Innovia Medical, St. Paul, MN, USA) and, around the same time, Minne Ties Agile MMF received clearance from the FDA for marketing.
Educating Innovators of Medical Technologies
Figure 20.2 Rendering of the Minne Ties Agile MMF device. Image from https://www.minneties.com/.
20.5 CLINICAL IMMERSION Needs finding is the critical first step in the medical device innovation process, and it is widely recognized that immersion in the clinic is an essential part of educating and/ or reeducating the device designer who is not a clinician. Almost all medical device education programs include a period where participants immerse themselves in the clinic which, broadly interpreted, can include procedure suites, operating rooms (including hybrid ORs), imaging centers (X-ray, CT, PET, and MRI), patient rooms, waiting areas, outpatient facilities, assisted living centers, nursing homes, or any other healthcare setting. For example, the IEM at the University of Minnesota offers a clinical immersion program for nonclinicians, targeted at professionals in a medical technology company who may never have observed a live procedure that uses the category of technology they are developing.6 The purpose of each immersion program is for participants to develop a more in-depth understanding of the environment in which medical devices are used. Regarding program outcomes, it is expected that participants are able to design devices that better meet the needs of patients and clinicians and are able to develop relationships with physicians that could facilitate future collaborations, including future clinical trials. Participants in the program undertake focused (day or weeklong) courses and receive formal training in a clinical setting on processes, policies, and procedures relating to a variety of healthcare situations. Because the course setting is clinics in the University of Minnesota hospitals, groups are deliberately kept small so as not to interfere with normal clinic operations; this has the added advantage of maximizing the learning experience for students. Participants are charged a fee, with the majority of course revenues going to the clinical specialties hosting the program as partial compensation for their time, and many of the services use the revenue to support their resident research programs.
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One of the weeklong clinical immersion programs offered by IEM is focused on general surgery. Enrolled students include medical device designers, quality control individuals, clinical trial and regulatory specialists, marketing professionals, product line managers, and/or senior executives. The surgery week draws upon many of the specialties in the Department of Surgery at the University of Minnesota and includes observations of procedures, guidance by residents, pre- and postsurgical rounds, grand rounds, and tours of relevant research and surgical services laboratories. The program is intensive, lasting five full days from 6:30 a.m. to at least 4:00 p.m. Surgeries observed could include cardiothoracic, colon and rectal, gastrointestinal and bariatric, pediatric, pediatric cardiac, plastic and reconstructive, surgical oncology, and transplantation. Participants are trained in OR policies, procedures, and etiquette, including scrubbing in for surgery. Midday students attend lunch and a Q&A session with surgical residents, where they discuss the case they just observed and preview the case for the following day. IEM encourages participants to observe and study all types of surgeries, because the skilled innovator may be able to connect the dots and use what they observe in one surgical specialty to invent the next innovative device for another specialty.
20.6 CONFERENCES The lifelong student of medical device innovation should regularly attend scientific, engineering, and clinical conferences, both domestic and international, that focus on aspects of medical devices and the medical device design process. For example, the Design of Medical Devices conferences in Minnesota, Europe, and China have offered sessions on device innovation. Likewise, the following list represents just a small sample of the conferences that provide similar sessions: Transcatheter Cardiovascular Therapeutics (TCT), International Conference for Innovations in Cardiovascular Systems (ICI), Catheter Interventions in Congenital and Structural Heart Disease (CSI), Heart Rhythm Society (HRS), European Society of Cardiology (ESC), MedTech Conference (AdvaMed), International Engineering in Medicine and Biology Conference (IEEE EMBC), and Biomedical Engineering Society Annual Meeting (BMES).
20.7 BOOKS Finally, books and handbooks are excellent resources to start with for the student of medical device innovation. While there are many textbooks on product and engineering design, a more modest selection is available with a focus on medical technology innovation and development. Some of the more popular texts include: • Medical Device Innovation Handbook (WK Durfee and PA Iaizzo). • Biodesign: the Process of Innovating Medical Technologies (P Yock, S Zenios, J Makower, T Brinton, U Kumar, J Watkins, L Denend, T Krummel, and C Kurihara).
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• Medical Instrumentation: Application and Design (JG Webster). • Design of Biomedical Devices and Systems (PH King, RC Fries, and AT Johnson). • Contextual Inquiry for Medical Device Design (MB Privitera). • Medical Device Design (P Ogrodnik). The medical instrumentation text by Webster8 has long been used in biomedical engineering instrumentation and electronics courses but does not cover the innovation process. The short text by Privitera9 is a detailed description of needs finding via observations and interviews but is restricted to that portion of the innovation process. The King10 text provides complete coverage of the engineering design process of medical devices, with less coverage on finding needs or developing a business case for a product. The Ogrodnik11 text describes most of the medical device design process with an emphasis on what is needed to navigate the regulatory path. The most comprehensive reference is the 952-page Biodesign textbook from the Stanford group,12 a step-by-step guide to all aspects of the medical technology innovation process with many case studies. The text follows the IdentifyInventImplement process popularized by the Stanford group and is one of the few resources that covers the complete process including building a business case for a product. It is one of the few resources that covers reimbursement strategy, which is critical to medical device development. Finally, there is the Medical Device Innovation Handbook from the University of Minnesota,13 which covers much of the same material, but in a more compact format. This handbook originated in the innovation workshops described elsewhere in the chapter and is available as a no-cost download (z.umn.edu/mdih) for anyone wanting to learn about the medical technology innovation process.
20.8 SUMMARY Medical device innovation is an exciting and rewarding endeavor or career path. It is not for the weak of heart, for it requires much study, hands-on training, skill, continued lifelong learning, and the ability to bounce back from many failures. The common advice from serial, highly experienced entrepreneurs is to (1) surround yourself with a great team with vast knowledge in all associated areas; (2) be passionate about your ideas and be a champion of the technology; (3) fail fast and learn from these failures; (4) plan on working incredibly hard; and above all (5) enjoy the process.
REFERENCES 1. Medical Industry Leadership Institute, Carlson School of Management, University of Minnesota. hhttps://carlsonschool.umn.edu/faculty-research/medical-industry-leadership-institutei [accessed 18.03.25]. 2. New Product Design and Business Development Program, University of Minnesota. hwww.npdbd.umn.edui [accessed 18.03.25].
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3. Carlson School of Management, University of Minnesota. Executive Education. hhttps://carlsonschool.umn. edu/executive-educationi [accessed 18.03.25]. 4. Advanced Cardiac Physiology and Anatomy Short Course, University of Minnesota. hhttps://www.physiology.umn.edu/degrees-and-programs/industry-professionals/phsl-5510-cardiac-short-coursei [accessed 18.03.25]. 5. Institute for Engineering in Medicine, University of Minnesota. Design of Medical Devices Conference. hhttp://www.iem.umn.edu/events/index.htmli [accessed 18.03.25]. 6. Institute for Engineering in Medicine, University of Minnesota. Education and Outreach. hhttp://www.iem. umn.edu/education/index.htmli [accessed 18.03.25]. 7. Medical Alley Association. hhttps://www.medicalalley.org/i [accessed 18.03.25]. 8. Webster JG, editor. Medical instrumentation: application and design. 4th ed. New York, NY: Wiley; 2009. 9. Privitera MB, editor. Contextual inquiry for medical device design. Waltham, MA: Academic Press; 2015. 10. King PH, Fries RC, Johnson AT, editors. Design of biomedical devices and systems. 3rd ed. Boca Raton, FL: CRC Press; 2014. 11. Ogrodnik PJ, editor. Medical device design: innovation from concept to market. London: Academic Press; 2012. 12. Yock PG, Zenios S, Makower J, Brinton TJ, Kumar UN, Watkins FTJ, et al., editors. Biodesign: the process of innovating medical technologies. 2nd ed. Cambridge: Cambridge University Press; 2015. 13. Durfee W, Iaizzo P, editors. Medical device innovation handbook. 6.0 ed. University of Minnesota Medical Devices Center; 2017. hz.umn.edu/mdihi [accessed 18.03.25].
Educating Innovators of Medical Technologies William K. Durfee1 and Paul A. Iaizzo2 1
Department of Mechanical Engineering, University of Minnesota, Minneapolis, MN, United States Department of Surgery, Institute for Engineering in Medicine, University of Minnesota, Minneapolis, MN, United States
2
20.1 INTRODUCTION Learning to be an innovator in medical technologies has many similarities to innovating in other technology areas. At the same time, medical technology has unique features that can make it more challenging to transfer what is learned about innovation into another space, such as consumer electronics. For example, medical technologies are highly regulated, so a strong knowledge of continually changing regulatory pathways is needed. Some medical devices are expensive and sales of such devices will only occur if the cost is reimbursed by third party payers; therefore, knowledge of effective reimbursement strategies is also required. Because successful medical devices must have clear evidence of outcome effectiveness, the innovator must know how to conduct a clinical trial and perform post-market surveillance. Further, a medical technology must be adopted by practicing clinicians, so the innovator must understand the clinical environment, knowledge that cannot be gained from only reading, but rather by immersion in the clinic. This chapter describes various methods for educating the next generation of medical technology innovators and for continuing the education of current innovators who wish to stay up-to-date. Some of these opportunities occur within undergraduate and graduate programs at universities around the world and thus are targeted toward degree-seeking students. Other education programs are developed for working professionals who are looking to transition into the medical technology sector from an associated or completely unrelated field. Still other methods focus on clinicians who wish to become clinician innovators and become substantially involved in developing new medical devices that solve the problems they experience every day within their practices. Still other programs occur in large medical device companies that are seeking to keep their employees up-to-date. The medical device education programs described in this chapter are only part of what it takes to educate an ultimately successful innovator, as much of the responsibility rests with the lifelong learner. To start, one must become familiar with relevant Engineering in Medicine DOI: https://doi.org/10.1016/B978-0-12-813068-1.00020-8
r 2019 Elsevier Inc. All rights reserved.
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medical literature, first studying textbooks, then adding literature reviews and specific journal articles that cover the anatomy, physiology, diseases, and therapies related to the area of interest. The expert innovator must have skills in searching PubMed for relevant articles as well as the United States Patent and Trademark Office site for patents.
20.2 UNIVERSITY COURSES AND DEGREE PROGRAMS For many engineering and business students, an introduction to the medical technology development process comes through undergraduate or graduate design or business analysis courses. Others choose to learn these processes through a postgraduate professional degree program that covers one or more specific areas of medical technology. This section provides a few examples of potential courses and programs.
20.2.1 Engineering design courses Worldwide, nearly all accredited undergraduate engineering programs culminate in a required capstone course, where students apply what they have learned in classes. In the typical capstone course, a team of students works on a design project for a client over the course of a 15-week semester. While most of the course consists of project work, the didactic portions of such training typically cover the design process, and many include lectures on needs finding, ideation, prototyping, patents, writing and presenting, and project management, among other topics. A typical example is ME4054 Design Projects, the capstone course for students in the Department of Mechanical Engineering at the University of Minnesota, where many of the projects are medically related. A few examples of previous projects in this course include an adjustable length tracheostomy tube for Smiths Medical, a cable-driven hand orthosis for Abilitech Medical, and an intracranial targeting guide for the Department of Neurosurgery, University of Minnesota. Typically, project mentors from the client organization also participate to provide students with real-world training in the relevant aspects of medical technology development. Several universities also have developed design courses that focus exclusively on medical technologies, with the didactic portion guiding students through a condensed need finding, concept creation, and prototype build and test process. Examples include BMEN 4001/4002, the two-semester capstone design sequence in the Department of Biomedical Engineering at the University of Minnesota, 2.75 Medical Device Design at Massachusetts Institute of Technology, MENG/BENG 404 Medical Device Design & Innovation at Yale University, BME 4050C Medical Device Design at the University of Cincinnati, ME 294 Medical Device Design at Stanford, and BIOE 451/452 at Rice University, among many others.
Educating Innovators of Medical Technologies
20.2.2 Business analysis courses Still other university programs available for the beginning innovator focus on analyzing the associated business opportunity for medical technologies. An example is the Medical Industry Valuation Lab, part of the Medical Industry Leadership Institute within the Carlson School of Management at the University of Minnesota.1 The Valuation Lab provides industry innovators with a rapid, comprehensive business analysis of their proposed medical innovation and its prospects in current and projected markets. Teams of graduate students from the Carlson School of Management, College of Liberal Arts, College of Science and Engineering, Law School, and the Academic Health Center conduct these analyses, taking on three projects over the semester. Each project is a rapid, 5-week market assessment that examines intellectual property, market size, regulatory path, reimbursement strategy, and financial return. Importantly, the students and faculty mentors sign a nondisclosure agreement with companies, so that confidential information about the innovation can be freely exchanged. Typically, the analytical results are provided to the client in a 15-page business analysis document as well as an in-person presentation, where the critical findings are delivered and discussed. Importantly for the success of this training program, clients come from large and small companies from Minnesota and around the world. In addition, the Valuation Lab routinely assesses the potential commercial viability of medical technologies created in various University of Minnesota research labs. Recently, the Valuation Lab examined a new way of measuring muscle strength and fatigue in children with muscular dystrophy. University on Minnesota investigators had developed a novel, low-cost prototype device that allowed for accurate measurements while motivating the user to exert maximal voluntary muscle force. The Valuation Lab team studied clinical literature related to muscular dystrophy, interviewed neurologists, physical therapists, and clinical care coordinators, examined regulatory and reimbursement paths, conducted a preliminary patent search to establish freedom-to-operate, determined market size, and created pro forma financials with probable income and expenses should a business be formed around the product. Importantly, the team ultimately recommended against further investment in the innovation due to the small market, yet pointed out a possible avenue for licensing the associated technology and/or associated testing procedures.
20.2.3 Degree programs Along with individual courses, some universities offer degree programs specifically related to medical technology innovation. One example, targeted at working professionals, is the Master of Science in Medical Device Innovation, a 14-month program led by professionals from medical technology industry, and part of the Technological
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Leadership Institute at the University of Minnesota. Other examples include the Regulatory Affairs and Services Masters program at St. Cloud State University in Minnesota, and the PhD and Masters programs offered by the Department of Regulatory and Quality Sciences at the University of Southern California. The number of these programs is growing, thus medical device innovators who want to hone their skills should identify locally available degree programs, some that can even be completed through remote learning.
20.2.4 Medical device design and development courses While some courses in medical device innovation have an engineering design focus and others emphasize business development, a few universities have uniquely developed comprehensive courses that combine both elements. One example is the graduate-level, two-semester New Product Design and Business Development (NPDBD) course offered by the College of Science and Engineering and the Carlson School of Management at the University of Minnesota.2,3 For over 20 years, this multidisciplinary, experiential course has engaged students in the product development and entrepreneurial process. NPDBD connects leading medical device companies with University of Minnesota graduate students from different disciplines to develop valuable new products. Throughout a 9-month project cycle, each client company sponsors a team of engineering and business students in connection with a specific product. Drawing on guidance from their client, faculty coaches, industry advisors, and student teams works independently to conduct background research and to develop a working prototype and accompanying business plan, which the client then carries forward to launch. The primary aim of the course is to educate graduate students in the knowledge and skills required to commercialize a new product, including new medical devices. A secondary aim is to return value to the client company by moving their new product closer to launch. The learning objectives for students include the ability to work with engineering or science specialists and business management teams, the ability to define and achieve both short- and long-term technical and business goals, understanding the steps necessary to produce a viable product, and appreciating the difference between a plan on paper and the reality of a rapidly evolving technical product market. Each team consists of approximately six students (half engineering, half business), along with a faculty coach and various client company representatives, all working together over 9 months to develop a working prototype product and business plan for the client company. Products are real and are taken through launch by the sponsoring company. Each project addresses market feasibility (What is the need? Do customers want the product?), technical feasibility (engineering design, prototyping, and
Educating Innovators of Medical Technologies
manufacture), and financial feasibility (how much money the company will make). The overall NPDBD process can be summarized as follows: 1. Discover: Understand the context and explore the opportunity space. 2. Define: Define the customer need and state the problem. 3. Create: Create a solution to the need. 4. Deliver: Deliver on the solution. During the first semester, the team is focused on discovery, which includes these components: 1. Understand the context: Research the disease state, existing solutions, competing products, and relevant technology. Use secondary market research to define market trends. 2. Discover needs: Conduct customer interviews and develop a needs statement. Initiate a product requirements document. 3. Ideate: Create one or more concepts that satisfy the need. Execute a rough working prototype of each concept. 4. Assess: Conduct initial screen for market, technical, and financial feasibility. In the second semester, the team turns its attention to execution, including these steps: 1. Validate the concept: Gather customer reactions to the concept. Conduct preliminary engineering bench tests of the prototypes. Select the concept to execute. 2. Develop the concept: Finalize the detailed product requirements and engineering design. Fabricate, assemble, and bench test an alpha prototype. Gather customer reactions to the prototype. Create a manufacturing plan. Protect intellectual property. 3. Develop the business plan: Use the Canvas model to solidify the value proposition, customer segment, distribution channel, cost structure, and revenue stream. 4. Assess: Conduct final screen for market, technical, and financial feasibility. 5. Create hand-off plan for the client to continue execution. The NPDBD course meets once a week (attendance is required and expected) for lectures that cover the basics of the product development process. For example, students receive instruction in sketching, low-resolution prototyping, and patent searching, as well as how to define and research markets, how to gather primary market data through voice-of-the-customer observations and interviews, and how to financially value a new product or business. In addition, each team schedules two weekly team meetings. One team meeting includes the faculty coach and company representative (when available), with the purpose being to make decisions and set high-level direction. The second team meeting includes students only, with the intent to discuss results, work on documents, report progress, and create detailed plans. Each year, the course hosts six or seven projects; clients are often well-established companies that pay a sponsorship fee of $25,000. In some cases, clients are start-up
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companies or solo entrepreneurs that pay a lesser fee of $10,000. These fees support the extra administrative and instructional costs of running the course, as well as expenses for prototyping, supplies, and technical support. The clients and projects vary from year to year, depending on the companies involved and their specific product needs. A list of projects is provided to students on the first day of class, and team assignments are based on preference and an attempt to balance teams for equal business and engineering representation. The student team is a self-directed work group with leadership selected by the team, while the faculty coach is there to guide and mentor the team. Projects are completed in collaboration with the client, so the company representatives play an important role; it is essential that the goals and direction taken by the student team align with those of the company. Typically, this occurs through regular and thorough communication between students and company sponsors. One of the consequences of working on real projects for clients is that company sponsors have an interest in controlling the flow of information about the project and in determining who has ownership of new ideas. Therefore, all students and faculty in the course sign nondisclosure and intellectual property agreements with each of the sponsoring clients. The nondisclosure agreement enables the client to share confidential information with the student team, and the intellectual property agreement assigns patent ownership to the client for any inventions created by the students or faculty. One of the implications of the NPDBD nondisclosure and intellectual property agreements is that students cannot reveal any details about their project to friends, family members, or university experts outside the course from whom they seek advice. Also, while students will not own the patent on any invention resulting from the course, they will be named inventors on the patent. The language of these agreements used in NPDBD was the result of negotiations early in the course history between the Office of the General Counsel at the University of Minnesota and several early client companies. Because students sign agreements with all companies sponsoring a project in that year, information can be freely exchanged among teams during class lectures and presentations. Students have successfully worked on dozens of projects over the history of the NPDBD course; Table 20.1 lists projects for the past 5 years of the course.
20.3 WORKSHOPS AND SHORT COURSES There are also several workshops and short courses sponsored by universities, conferences, and trade organizations, targeting professionals who wish to become medical device innovators. Some have a relatively narrow focus. For example, each year the Institute for Engineering in Medicine (IEM) at the University of Minnesota offers two weeklong courses, one in advanced cardiac physiology and anatomy4 and the
Educating Innovators of Medical Technologies
Table 20.1 Sponsors and Projects of the New Product Design and Business Development Course, University of Minnesota (last 5 years) Year Sponsor Student team project
201617
201516
201415
201314
201213
IKC America Spinal Designs Agora Investment SelfEco 3VO Medical Medtronic Medtronic Medtronic Agora Investment Digital Design Studios IKC America University of Minnesota Medtronic Medtronic Borkon Shooting Lab YOXO CCEFP Medtronic EmbraSure Medical Tactile Medical Boread Medical Tech. Modiron Medical Devices Center GeneSegues Gromit & Bronk Medical Devices Center Medtronic Smiths Medical Smiths Medical Surgical Robotics Lab
Product to treat veterinary injuries Product to alleviate back pain New type of backpack Self-fertilizing planter for coffee beans Birthing aid Device for treating arterial lesions Device for transcatheter heart valve Sensor for cardiac ablation procedures New inline skate concept New way to treat bunions Product to treat athletic injuries New toothbrush Product for transcatheter aortic valve replacement Method to access heart for cath lab procedures Product related to women’s’ health Product for training basketball shooting skills New toy using recycled materials New applications for small hydraulics Monitoring system for cryoablation New way to tie the jaw shut Active compression garment Femoral artery access device Method for removing wrinkles from clothing Monitoring anesthesia motor block Skin patch for drug delivery Child stroller Ablation monitoring system iPad product information app Warming blanket Vascular access Surgical skills testing system
For complete project list, see www.npdbd.umn.edu. CCEFP, Center for Compact and Efficient Fluid Power.
other in the anatomy and physiology of the pelvis and urinary system. The cardiac course has been extremely popular for the past 19 years and was initially developed for cardiovascular device designers and managers, many of whom never had physiology or anatomy in college or graduate school. The course includes lectures on anatomy, cardiac performance, heart disease, surgical procedures, and cardiac devices, among other topics. The lectures are supplemented with hands-on cadaver gross anatomy labs in which students work in teams to dissect a human heart. Table 20.2 shows
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Table 20.2 Schedule for Cardiac Physiology and Anatomy Short Course (University of Minnesota) Monday
Welcome Course Introduction/General Review of the Cardiovascular System Cardiac Myocytes The Conduction System of the Heart 12-Lead ECG (Demonstration) LUNCH (provided) EKG Lab—Biopac Systems Control of Coronary Blood Flow during Normal and Disease States Thoracic Surface Anatomy and Great Vessels Gross Anatomy Lab 1: Thoracic Surface Anatomy, Subclavian Region and Great Vessels
Metzger Iaizzo
7:45 a.m. 8:00 a.m.
Barnett Iaizzo Howard
9:00 a.m. 10:00 a.m. 11:00 a.m. 121 p.m. 12:30 p.m.
VHL graduate students Katz Weinhaus Weinhaus/Cook/ Iaizzo
Keynote Presentation: “Resiliency: Excelling in a Tough Environment” Dr. Rosemary Kelly, Professor and Chief, Division of Cardiothoracic Surgery, University of Minnesota
1:30 p.m. 2:30 p.m. 3:00 p.m. 7:00 p.m.
Tuesday
Cardiac Development Mechanical Aspects of Cardiac Performance: Blood Pressure, Heart Tones, and Diagnoses Large Mammalian Comparative Cardiac Anatomy Cardiac Energy Metabolism LUNCH (provided) Use of Device-based Approaches to Treat Cardiovascular Diseases Associated with Increased Sympathetic Activity Congenital Cardiac Disease Surface Anatomy of Heart and Lungs Gross Anatomy Lab 2: Lungs, Great Vessels and Coronary Vessels
Martinsen Hutchins
8:00 a.m. 9:00 a.m.
Hill Iles
10:00 a.m. 11:00 a.m. 12:00 p.m. 1:00 p.m.
Osborn
MacIver Weinhaus Weinhaus/Cook/ Iaizzo
2:00 p.m. 3:00 p.m. 3:30 p.m.
Roukoz Laske Eggen Bateman
8:00 a.m. 9:00 a.m. 10:00 a.m. 11:00 a.m.
Raveendran
121 p.m. 1:00 p.m.
Wednesday
Catheter Ablation of Cardiac Arrhythmias 3D Electrophysiologic Cardiac Mapping Pacing and Defibrillation Valve Anatomy and Transcatheter Valves/ Minimally Invasive Valve Repair Procedures LUNCH (provided) Interventional Cardiology: Stents, Closure Devices, etc.
(Continued)
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Table 20.2 (Continued)
The University of Minnesota: One of the Pioneering Institutions in the Field of Cardiovascular Surgery Internal Anatomy of the Heart and Posterior Mediastinum Gross Anatomy Lab 3: Internal Anatomy of the Heart and Posterior Mediastinum
Iaizzo
2:00 p.m.
Weinhaus
3:00 p.m.
Weinhaus/Cook/ Iaizzo
3:30 p.m.
Sivanandam Loushin Beilman Huddleston Weinhaus Weinhaus/Cook
8:00 a.m. 9:00 a.m. 10:00 a.m. 11:00 a.m. 121 p.m. 1:00 p.m. 1:30 p.m.
Iaizzo
1:30 p.m.
Metzger
8:00 a.m.
John Iaizzo
9:00 a.m. 10:00 a.m.
Liao
11:00 a.m.
Martin
121 p.m. 1:00 p.m.
Bateman
2:00 p.m.
Weinhaus/Cook/ Iaizzo
3:00 p.m.
Thursday
Introduction to Echocardiography Intro to Anesthesia for Cardiac Surgery Monitoring in the ICU Ex Vivo Perfusion of the Heart or Lungs LUNCH (provided) Clinical Anatomy (anatomy review) Gross Anatomy Lab 4: Clinical Anatomy (anatomy review) Small Group Demos: In vitro swine, fresh cadaver Friday
Experimental Gene Therapeutics for Heart and Muscle Ventricular Assist Device Therapy Novel Visualization of Functional Human Cardiac Anatomy Employing Visible Heart Methodologies Minimally Invasive Cardiac Surgery: Technique Overview LUNCH (provided) Patient Continuum of Care Following Cardiac Interventions Cardiac Anatomy Modeling, Virtual Reality, Virtual Prototyping and Atlas Website Tutorial Gross Anatomy Lab 5: Finish Dissections and “Grand Rounds”
a typical schedule for this course. This type of short course is an effective way to obtain academic training in a short, intense period. Other workshops cover the medical device innovation process. One example is the Academy of Innovation, a 1-day workshop held in conjunction with the annual International Conference for Innovations (ICI) meeting in Tel Aviv for interventional cardiologists and targeted to physicians who wish to become entrepreneurs and innovators. The workshop has three components: (1) didactic
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Figure 20.1 ICI Academy of Innovation. ICI, International Conference for Innovations.
lectures on medical technology innovation, including the innovation process, assessing needs, regulatory, patents, and other relevant topics; (2) war stories from seasoned medical technology entrepreneurs to contribute a real-world focus; and (3) hands-on ideation and prototyping so that, by the end of the day, every participant has invented a new medical device concept (Fig. 20.1, Table 20.3). The hands-on activities are a highlight of the workshop. In one activity, small groups are given a needs statement and asked to prototype a solution to the need, using only the limited supplies provided (paper clip, index card, tongue depressor, foil, clothes pin, and other similar items). The goal is to design a solution for a specific customer-based need and to experience the utility of low-resolution prototyping methods for communicating an idea. In another activity, the group comes up with a need, invents a medical technology that meets the need, and then builds a first prototype using a large “pile of junk” (miscellaneous) parts collected from surgery and procedure suites (catheters, tubes, syringes, valve delivery units, and surgical instruments) along with foam board, hot glue, and duct tape. ICI has hosted this workshop for 8 years and has trained hundreds of participants in the innovation process. A similar workshop was spun off and is offered as part of the annual Design of Medical Devices Conference in Minneapolis, Minnesota (http://www.dmd.umn.edu/).5,6 Additional workshops occur at the Transcatheter Cardiovascular Therapeutics (TCT) conference and other professional scientific sessions where innovation is emphasized. Still other workshops are organized by industry trade organizations. For example, Regulatory 101 is the most popular of many events hosted by Minnesota’s Medical Alley Association.7 This 1-day workshop provides a basic overview of the regulatory process then examines regulatory pathway topics such as pre-submission strategy, clinical trials under investigational device exemption, premarket approval submissions, and post-market surveillance. Invited speakers typically have real-world experience and come from regulatory consultancy firms and the regulatory divisions of medical technology companies.
Educating Innovators of Medical Technologies
Table 20.3 Agenda for the Academy of Innovation (1-day workshop on medical technology innovation, part of ICI meeting, Tel Aviv)
08:3008:50 08:5009:00 09:0009:20 09:2009:40 09:4010:00 10:0010:30 10:3011:00 11:0011:45 11:4512:05 12:0512:30 12:3013:10 13:1013:30 13:3013:50
13:5014:10 14:1014:30 14:3015:10 15:1015:30 15:3016:00 16:0016:20 16:2016:40 16:4017:15 17:15
Reshaping Medical Pipelines—How Clinicians are Becoming Innovators Perspective on Innovation Development within an Academic Medical Center How New Medical Products are Developed— Overview of New Product Development Process Essentials of Creativity—Sketching, Notebooks, and Documenting Brainstorming Warmup Testing Your Medical Device Idea: Bench Tests, Preclinical, Clinical Trials Networking Break Innovation Exercise 1: Generate Ideas Protecting your Intellectual Property through Patents Device Innovation: Role of Regulatory Requirements in the U.S. Lunch Inventing, Developing, and Commercializing New Medical Devices How to Determine if a New Device is Needed— Market Evaluation and Needs Assessment Methods The Corporate View of Technology Assessment and Acquisitions From an Idea to Exit—the Bumpy Road Today Innovation Exercise 2: Developing a New Cardiovascular Product Digital Health Revolution—A New Player in the Innovation Market Networking Break Team Presentations Fostering a Culture of Do-it-yourself Innovation Cardiovascular Medical Device Innovation: A Discussion Q&A Panel Adjourn
Lotan Beyar Durfee Iaizzo & Durfee Durfee Iaizzo
Durfee Oktay
Pardo Richardson
Laske Essinger
Fitzgerald
Cohn
20.4 INNOVATION FELLOWS PROGRAMS For early-career individuals who can commit to a year of full-time intensive training in medical technology innovation, fellowship programs offer a unique opportunity. Started by Stanford as part of their Biodesign program, there are now many variations of fellowships offered at universities around the world, including the University of
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Minnesota, Texas Medical Center and Rice University, Johns Hopkins University, Hebrew University, Indian Institute of Technology at Delhi, and others. One example is the Earl E. Bakken Medical Devices Center Innovation Fellows Program at the University of Minnesota, a full immersion education and product development program for medical device creation.6 Now in its 10thyear, the program has the primary goal of developing the next generation of entrepreneurial and intrapreneurial medical innovation leaders. Each year, eight fellows are selected in a competitive application process. Successful candidates are self-driven, motivated, embody an entrepreneurial spirit, and have an interest in medical devices. Preferred qualifications are an engineering or science PhD, a medical or health-related degree, a business degree, or substantial industry experiences. Typically, a fellowship class includes individuals that represent each of these categories. The program teaches fellows a disciplined innovation process of understanding clinical environments, finding and screening needs, and developing products and businesses that satisfy those needs. In Minnesota, there is a Phase 1 segment, which is an 8-week boot camp with intensive didactic lectures drawn from university and local medical technology community experts. Phase 2 of the fellowship program consists of 8 weeks of clinical immersion where fellows are inserted into local hospitals and clinics to directly observe procedures and interact with clinicians. The output of this phase is a set of filtered, significant need statements. Finally, there is Phase 3, product development, which is the bulk of the program where the fellows, working in small teams and on several projects, ideate concepts and take concepts through several cycles of buildinventvalidate, with the aim of creating new business opportunities that could be further pursued in a startup (for entrepreneurs) or within an established company (for intrapreneurs). Other fellows programs have similar goals and timelines. Across all of the fellows programs, many medical device startups have emerged, a testament to the effectiveness of this type of experiential education. A recent Minnesota fellows success story is Minne Ties, an innovative way of achieving maxilla-mandibular fixation to heal a jaw fracture (Fig. 20.2). The conventional method is to use metal wires which patients find uncomfortable; they additionally present a safety hazard for surgeons who must take care not to injure themselves or the patient with the sharp edges of cut wires. Alan Johnson, a 2012 Minnesota Innovation Fellow, saw the need while observing jaw fracture repair during the clinical immersion phase of the program. Johnson invented what is essentially a medical form of plastic tie wrap that contractors use to secure cable bundles. After many stages of prototyping and testing, Minne Ties emerged as a safe, simple, and efficient means of fixing the jaw. In 2017, the technology was licensed by Summit Medical (now Innovia Medical, St. Paul, MN, USA) and, around the same time, Minne Ties Agile MMF received clearance from the FDA for marketing.
Educating Innovators of Medical Technologies
Figure 20.2 Rendering of the Minne Ties Agile MMF device. Image from https://www.minneties.com/.
20.5 CLINICAL IMMERSION Needs finding is the critical first step in the medical device innovation process, and it is widely recognized that immersion in the clinic is an essential part of educating and/ or reeducating the device designer who is not a clinician. Almost all medical device education programs include a period where participants immerse themselves in the clinic which, broadly interpreted, can include procedure suites, operating rooms (including hybrid ORs), imaging centers (X-ray, CT, PET, and MRI), patient rooms, waiting areas, outpatient facilities, assisted living centers, nursing homes, or any other healthcare setting. For example, the IEM at the University of Minnesota offers a clinical immersion program for nonclinicians, targeted at professionals in a medical technology company who may never have observed a live procedure that uses the category of technology they are developing.6 The purpose of each immersion program is for participants to develop a more in-depth understanding of the environment in which medical devices are used. Regarding program outcomes, it is expected that participants are able to design devices that better meet the needs of patients and clinicians and are able to develop relationships with physicians that could facilitate future collaborations, including future clinical trials. Participants in the program undertake focused (day or weeklong) courses and receive formal training in a clinical setting on processes, policies, and procedures relating to a variety of healthcare situations. Because the course setting is clinics in the University of Minnesota hospitals, groups are deliberately kept small so as not to interfere with normal clinic operations; this has the added advantage of maximizing the learning experience for students. Participants are charged a fee, with the majority of course revenues going to the clinical specialties hosting the program as partial compensation for their time, and many of the services use the revenue to support their resident research programs.
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One of the weeklong clinical immersion programs offered by IEM is focused on general surgery. Enrolled students include medical device designers, quality control individuals, clinical trial and regulatory specialists, marketing professionals, product line managers, and/or senior executives. The surgery week draws upon many of the specialties in the Department of Surgery at the University of Minnesota and includes observations of procedures, guidance by residents, pre- and postsurgical rounds, grand rounds, and tours of relevant research and surgical services laboratories. The program is intensive, lasting five full days from 6:30 a.m. to at least 4:00 p.m. Surgeries observed could include cardiothoracic, colon and rectal, gastrointestinal and bariatric, pediatric, pediatric cardiac, plastic and reconstructive, surgical oncology, and transplantation. Participants are trained in OR policies, procedures, and etiquette, including scrubbing in for surgery. Midday students attend lunch and a Q&A session with surgical residents, where they discuss the case they just observed and preview the case for the following day. IEM encourages participants to observe and study all types of surgeries, because the skilled innovator may be able to connect the dots and use what they observe in one surgical specialty to invent the next innovative device for another specialty.
20.6 CONFERENCES The lifelong student of medical device innovation should regularly attend scientific, engineering, and clinical conferences, both domestic and international, that focus on aspects of medical devices and the medical device design process. For example, the Design of Medical Devices conferences in Minnesota, Europe, and China have offered sessions on device innovation. Likewise, the following list represents just a small sample of the conferences that provide similar sessions: Transcatheter Cardiovascular Therapeutics (TCT), International Conference for Innovations in Cardiovascular Systems (ICI), Catheter Interventions in Congenital and Structural Heart Disease (CSI), Heart Rhythm Society (HRS), European Society of Cardiology (ESC), MedTech Conference (AdvaMed), International Engineering in Medicine and Biology Conference (IEEE EMBC), and Biomedical Engineering Society Annual Meeting (BMES).
20.7 BOOKS Finally, books and handbooks are excellent resources to start with for the student of medical device innovation. While there are many textbooks on product and engineering design, a more modest selection is available with a focus on medical technology innovation and development. Some of the more popular texts include: • Medical Device Innovation Handbook (WK Durfee and PA Iaizzo). • Biodesign: the Process of Innovating Medical Technologies (P Yock, S Zenios, J Makower, T Brinton, U Kumar, J Watkins, L Denend, T Krummel, and C Kurihara).
Educating Innovators of Medical Technologies
• Medical Instrumentation: Application and Design (JG Webster). • Design of Biomedical Devices and Systems (PH King, RC Fries, and AT Johnson). • Contextual Inquiry for Medical Device Design (MB Privitera). • Medical Device Design (P Ogrodnik). The medical instrumentation text by Webster8 has long been used in biomedical engineering instrumentation and electronics courses but does not cover the innovation process. The short text by Privitera9 is a detailed description of needs finding via observations and interviews but is restricted to that portion of the innovation process. The King10 text provides complete coverage of the engineering design process of medical devices, with less coverage on finding needs or developing a business case for a product. The Ogrodnik11 text describes most of the medical device design process with an emphasis on what is needed to navigate the regulatory path. The most comprehensive reference is the 952-page Biodesign textbook from the Stanford group,12 a step-by-step guide to all aspects of the medical technology innovation process with many case studies. The text follows the IdentifyInventImplement process popularized by the Stanford group and is one of the few resources that covers the complete process including building a business case for a product. It is one of the few resources that covers reimbursement strategy, which is critical to medical device development. Finally, there is the Medical Device Innovation Handbook from the University of Minnesota,13 which covers much of the same material, but in a more compact format. This handbook originated in the innovation workshops described elsewhere in the chapter and is available as a no-cost download (z.umn.edu/mdih) for anyone wanting to learn about the medical technology innovation process.
20.8 SUMMARY Medical device innovation is an exciting and rewarding endeavor or career path. It is not for the weak of heart, for it requires much study, hands-on training, skill, continued lifelong learning, and the ability to bounce back from many failures. The common advice from serial, highly experienced entrepreneurs is to (1) surround yourself with a great team with vast knowledge in all associated areas; (2) be passionate about your ideas and be a champion of the technology; (3) fail fast and learn from these failures; (4) plan on working incredibly hard; and above all (5) enjoy the process.
REFERENCES 1. Medical Industry Leadership Institute, Carlson School of Management, University of Minnesota. hhttps://carlsonschool.umn.edu/faculty-research/medical-industry-leadership-institutei [accessed 18.03.25]. 2. New Product Design and Business Development Program, University of Minnesota. hwww.npdbd.umn.edui [accessed 18.03.25].
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3. Carlson School of Management, University of Minnesota. Executive Education. hhttps://carlsonschool.umn. edu/executive-educationi [accessed 18.03.25]. 4. Advanced Cardiac Physiology and Anatomy Short Course, University of Minnesota. hhttps://www.physiology.umn.edu/degrees-and-programs/industry-professionals/phsl-5510-cardiac-short-coursei [accessed 18.03.25]. 5. Institute for Engineering in Medicine, University of Minnesota. Design of Medical Devices Conference. hhttp://www.iem.umn.edu/events/index.htmli [accessed 18.03.25]. 6. Institute for Engineering in Medicine, University of Minnesota. Education and Outreach. hhttp://www.iem. umn.edu/education/index.htmli [accessed 18.03.25]. 7. Medical Alley Association. hhttps://www.medicalalley.org/i [accessed 18.03.25]. 8. Webster JG, editor. Medical instrumentation: application and design. 4th ed. New York, NY: Wiley; 2009. 9. Privitera MB, editor. Contextual inquiry for medical device design. Waltham, MA: Academic Press; 2015. 10. King PH, Fries RC, Johnson AT, editors. Design of biomedical devices and systems. 3rd ed. Boca Raton, FL: CRC Press; 2014. 11. Ogrodnik PJ, editor. Medical device design: innovation from concept to market. London: Academic Press; 2012. 12. Yock PG, Zenios S, Makower J, Brinton TJ, Kumar UN, Watkins FTJ, et al., editors. Biodesign: the process of innovating medical technologies. 2nd ed. Cambridge: Cambridge University Press; 2015. 13. Durfee W, Iaizzo P, editors. Medical device innovation handbook. 6.0 ed. University of Minnesota Medical Devices Center; 2017. hz.umn.edu/mdihi [accessed 18.03.25].