Key Risks in Medical Device Development

Understanding and mitigating these risks during medical device development can reduce your development timeline and ensure success.

Medical innovation is exciting. It’s thrilling to think a new therapy, device or product can improve the quality of or save lives. Who can’t get behind that? As a result, medical technology applications often rank highest amongst new startup ideas. With an ever-aging global population, there is increasing demand for healthcare solutions, advancements in technology and more efficient, accessible medical devices and services throughout the world.

However, developing a medical device in the modern era can be akin to navigating a minefield. Medical device development has inherent risks that encompass technical, regulatory and clinical factors. Mitigating these risks demands meticulous planning, rigorous testing and vigilant risk management throughout the entire product lifecycle to ensure safety and efficacy for patients and healthcare providers. Given these many critical considerations, medical device development is more complex than ever. 

As a result, medical device manufacturers need to thoroughly address many risks associated with developing a new device. This paper will highlight critical factors medical device manufacturers need to consider as development begins and throughout the product’s life cycle.