- The increased use of software and connected devices complicate the development process and introduce new risks at almost all stages of design and manufacturing.
- New competitors from inside and outside the traditional medical device space—are disrupting the market, with customer name recognition and expertise in developing both innovative and complex systems.
- Compliance with government and industry regulations remains a challenge, especially as regulatory bodies update standards that broaden inclusions to keep consumers safe.
Risk Management for Modern Medical Device Makers
For modern medical device developers, new market realities present favorable circumstances and worrisome challenges. Technological advances continue to evolve design and manufacturing, but increased demand and use cases also increases media scrutiny leaving manufacturers with precious little margin for error.