The Product Realization Group (PRG) works with many companies that are introducing new medical devices. PRG understands the special considerations that the federal regulatory framework presents to medical device product development. We combine our expertise in new product development, product design, and bringing products to scale with a deep understanding of medical regulations to enable our clients to take their product ideas to market.
The medical device market is still wide open and ripe for new product development. However, the new medical device developer must avoid the potential pitfalls of this complex, regulated field.
PRG invited an experienced panel to the SV Hardware Product Development Meetup to share their expert advice to entrepreneurs considering medical device development. The panel included medical device developers, investors, and seasoned tech executives:
- Jennifer Ernst, CEO at Tivic Health, a 20-year tech veteran was new to the world of medical device development when she started working at Tivic Health.
- Jeffrey Christian, CEO of Phoenix DeVentures, has been advising, collaborating and supporting medical device developers for over 20 years.
- Howard Edelman, CEO of Advanced Resin Therapeutics and co-chair of the medical device and digital health screening committee of Life Science Angels, an angel investment group investing in medical devices, diagnostics, pharmaceuticals, biotechnology, and digital health.
- Walt Maclay, President, and CEO of Voler Systems, consulting electronic engineers. Voler Systems does full-service R&D consulting from concept and design to production of medical devices for human use.
Question: How does medical device development differ from other types of product development?
Regulation is the controlling theme around medical device development.
- As Howard Edelman points out, regulation adds a layer of formalization to the product development process. Quality is critical throughout the process. Tracking the regulations and their changes is challenging.
- According to Walt Maclay, companies used to introduce devices in Europe before the US because the CE marking regulations were easier to gain compliance. With recent changes to CE regulations, more and more products are now introduced in the US first.
- Jeff Christian cautions that regulations are a necessary evil to the nature of medical work, to ensure a company does not do harm to the end user.
- The language of numbers (such as IEC 60601 for electrical design, and ISO 13485 for Quality Management Systems) in medical regulations–more so than in other fields, is part of the high learning curve Jennifer Ernst describes her transition to an FDA regulated product.
FDA regulations and culture are reflected in more drawn out development timelines– for example, a three month response times is not unusual for getting a response back from the FDA. The highly regulated environment also lends itself to waterfall development style in contrast to the agile development Jennifer used in previous tech ventures.
The full panel discussion of this question is covered in the video below.