Medical Device Design
Tuesday, April 10, 4:00-5:30, Ski-U-Mah, McNamara Alumni Center

Organizer: Mary Beth Privitera, Assistant Professor, University of Cincinnati, MDIEP

"Understanding and Applying FDA Draft Guidance for Improved Usability in Medical Devices"
Tor Alden, HS Design

"User Testing"
Stephen Nelson, Medtronic, Inc.

"Enhancing the Design Process via Knowledge Management"
Ken Merdan, R&D Director, Design Services, Boston Scientific Corporation

Session Abstract:

Medical Device Design has many different disciplines working collaboratively in order to provide the optimum clinical solution. 
This includes but is certainly not limited to the practices of biomedical, mechanical, electrical engineering, and industrial design. 
Each discipline as well as the entity through which they work e.g. consultant vs corporate design play a role in their processes. 
This multidisciplinary panel of experts will provide insights into their respective design process.

Session Organizer Bio:

Mary Beth Privitera, Assistant Professor, University of Cincinnati, MDIEP
Ms. Privitera is the Co-director in the Medical Device Innovation and Entrepreneurship Program at the University of Cincinnati. The program partners multidisciplinary student teams with physician innovators, and focuses on translating research efforts into viable product development opportunities. To date, the program has demonstrated results for clinical specialists in vascular surgery, interventional radiology, general surgery, cardiothoracic surgery, emergency medicine, pulmonary care, rehabilitative medicine, and neurology. The program convenes students from the industrial design, biomedical engineering, and business fields and enables them to learn about the other disciplines while conducting early-stage development of regulated medical products. Privitera is an Associate Professor of Biomedical Engineering with research focus in applied ethnography for design and the ergonomics of catheter based interventions. An expert in the application of human factors in medical product design, she has also worked in the medical device industry since 1988. She currently serves as a vice president of education for the Industrial Designers Society of America and previously served as a member of its national educational council. She is also a member of the Association for the Advancement of Medical Instrumentation Human Factors Committee and has co-authored various sections in AMMI/ANSI HE 75. In addition, she belongs to the American Society of Engineering Educators, the Product Development and Management Association, and the Design Management Institute. She has been associated with more than 40 product releases, holds several patents and provisional patents, and has published and lectured on a variety of topics including trans-disciplinary/collaborative design, innovation methodology, and medical product design. Privitera received her BS in industrial design from the University of Cincinnati in 1985 and her Master of Design from the University of Cincinnati in 1995.

Speaker Bios:

Tor Alden, HS Design
Tor Alden is principal of HS Design (HSD), a firm specializing in medical and life sciences product development. Alden has expertise in design research, strategy and new ventures. He has received over 30 patents and several design awards. Alden received his Bachelor’s in industrial design from Syracuse University, Master of Science degree in Technology Management from Stevens Institute of Technology.

Stephen Nelson, Medtronic, Inc.
Stephen Nelson is a member of the Human factors staff at Medtronic. He has a degree in industrial design from the University of Cincinnati and began working for Medtronic 2 years ago. 

Ken Merdan, R&D Director, Design Services, Boston Scientific Corporation
Ken directs a team focused on introducing and applying design tools and processes globally to create market-leading medical devices. The design team creates 3D models, drawings, and function-based models for products that are part of the Cardiology, Rhythm, & Vascular (CRV) division of Boston Scientific Corp. Ken has degrees in Mechanical Engineering (BSME) with an emphasis on design and the Management of Technology (MSMOT) both achieved through the University of Minnesota. He has worked for Boston Scientific for over 20 years; most recently contributing to the drug-eluting stent program and business process re-engineering efforts.

Presentation Abstracts:

"Understanding and Applying FDA Draft Guidance for Improved Usability in Medical Devices"
The FDA is taking a closer look to how the Medical Device industry is designing and testing User Interfaces. This presentation will highlight the recent FDA draft guidance for applying human factors and usability engineering to optimize medical device design. Highlights and case studies will focus on how usability techniques are used to fulfill proper design of medical device user interfaces.

"User Testing"
User testing is one of the key components of Human factors. This talk will outline the benefits of user testing as well as some strategies that help to ensure consistent results. High level examples will be shared as well as ways to communicate results with the larger design team.

"Enhancing the Design Process via Knowledge Management"
The presentation will provide perspectives about an organization’s ability to design and sustain a product from an engineering view by making historical knowledge more readily available through multiple approaches. Topics will include use of patient-specific representation and patient populations, visualization tools, technical communities, and virtual, computational-based modeling at an earlier stage of new product development.