Join us on May 24th for our next Expert Panel. To register for the event, click here.
Meet the Panelists
Jennifer Ernst, CEO at Tivic Health, was new to the world of medical device development when she started at Tivic Health in September 2016. But she had over 20 years experience at Xerox PARC, moving technology from the lab to market, and more recently as part of the core team built Thin Film Electronics ASA to $480MM market cap from an 8-person R&D team in 3 years. Ernst faced a learning curve in transitioning from tech to medical devices. She noted the longer time horizon in development created by regulatory requirements has taken getting used to. She had to adapt to a new set of quality standards (ISO 13485 versus ISO 9000). She’ll grin when she tells you about setting up a PRD Management system for the first time, and how the documentation systems differ from non-medical products. She expects to bring a medical device, Synus, to market by the end of 2018.
Jeffrey Christian, CEO of Phoenix DeVentures, has been advising and collaborating with medical device developers for over 20 years, following a career in engineering and product development of surgical and other medical devices. Phoenix DeVentures is a medical device development and manufacturing company. They design, develop and manufacture medical devices. A lot of their work is with doctors, helping them execute on their ideas for medical devices. Before working with a startup, Christian begins by evaluating the nature of the problem that the medical device is trying to solve. First, is it viable? Or is it just fanciful? Next, he asks whether the project is funded. Third, he evaluates whether the product is reimbursable. Finally, he looks at the potential size of the market. A common problem Christian encounters is that new medical device developers often pay more attention to the aesthetic of the design, often overlooking the selling features of the product.
Howard Edelman is also an experienced medical device executive with a broad background in bringing new products to market. Mr. Edelman is CEO of Advanced Resin Therapeutics, a broad-based drug delivery platform based on medical grade plant resins. Previously, Mr. Edelman was General Manager of Cothera, a division of United Orthopedic Group (purchased by Breg in 2014). Experienced in product development and operations, Edelman currently advises medical device companies. Additionally, he is also 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. Edelman is a seasoned medical device expert, who has worked in all aspects of medical device development, including strategy, regulatory, and clinical, helping to launch and grow companies.
Walt Maclay is 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. Voler’s expert medical device team has decades of design experience on hundreds of projects across a wide spectrum of medical devices. Their multi-disciplinary team knows the regulatory process and procedures and delivers high quality products on time and on budget. Voler Systems is known for their expertise in motion control, wireless technology, wearables, proof of concept projects, test equipment for Class 3 medicals, and regulatory requirements.
Medical device development requires a deep understanding of the FDA regulatory process. The regulations mandate a comprehensive set of capabilities, including documentation, quality controls and risk management. While medical product development generally follows a standard development process, there are unique challenges that must be addressed in this highly regulated industry.
On May 24, Ernst, Christian, Edelman and Maclay will participate in a panel discussion intended for those who are new to medical device development.
Topics to be Addressed
- Differences between an FDA regulated and a non-regulated product
- Helpful advice for medical device newbies
- Sharing the best approaches for funding
- Navigating FDA regulations & risk management
- Overcoming pitfalls that can delay or derail the development process
If you are interested in learning more about the development of technology based medical products and learning from industry experts what it takes to succeed in this market, then this session is for you.
Our experts will share real-life experiences developing medical device products at a variety of medical device companies including Intuitive Surgical, Boston Scientific, Advanced Cardiovascular Systems, Cardiometrics, Unisurge, Phoenix DeVentures, Cothera, Synus, Game Ready, Zeiss-Humphrey and more.
Agenda:
11:30 am – 12:00 noon Networking & lunch
12:00 pm – 12:10 pm Introductions
12:10 pm – 1:10 pm Expert Panel and Q&A
1:10 pm – 1:30 pm Networking & close
Location: Techcode (1172 Castro Street, Mountain View)
To register for the event, click here.
