First Step in Medical Device Design: What’s Your View?

by Noel Sobelman on June 12th, 2012

Noel Sobelman, Kalypso partner and leader of the firm's Life Sciences and New Product Development Execution practices, shared his view with Medical Design Technology on the critical first step to ensure the success of a new medical device idea through to market launch.

Once a new medical device idea is formulated, what is the critical first step to help ensure its success through to market launch?

There are several critical first steps that follow ideation, including strategic fit assessment, market and customer needs validation, competitive assessment, business case analysis, and intellectual property (IP) assessment.  However, one of the most important that most companies struggle with is proof of technical feasibility.  

Why is early proof of technical feasibility so important?

Simply stated, technology uncertainty adds risk to your project schedule. Companies can manage technology uncertainty by separating technology development (i.e., invention) from product development and building a technology assessment step into the front end of your product development process. In doing so, you can avoid entering full-scale development with unpredictable technologies that have not yet been reduced to practice. If too much “invention” is done during product development, the uncertain timing makes scheduling difficult, leading to missed launch windows.

Why do most companies struggle with proof of technical feasibility?

Technical feasibility is a hard concept to define. The engineer being held accountable for a delivery schedule will have a completely different definition than the marketer who wants to get on with development. Therefore, it is important to have clear understanding and alignment. This is achieved by applying objective technology maturity criteria to quantify when a technology is ready for design. Performance values or thresholds are established upfront and assessed as the technology moves through its development toward the feasibility point.

Topics: Medical Device, Medical Device Consulting, Medical Device Design, Medical Device Innovation, Medical Device Manufacturers, Medical Device Manufacturing, Medical Device Product Development, Product Development, Technical Feasibility

About the Author

Noel Sobelman, Partner Noel leads Kalypso's Life Sciences and New Product Development Execution practices, and loves the band Rush. Read more articles by Noel Sobelman