The Innovation Challenge for Medical Device OEMs: Navigating the Regulatory Environment

Tuesday, October 13, 2015

Source: Medical Design Technology

Innovation is the foundation for life-changing medical devices. But innovation alone is not enough to take a product to market and realize its potential.

Just ask any product commercialization manager how many innovative concepts didn’t meet payor reimbursement targets. Or ask any R&D engineer how many brilliant, working prototypes sit collecting dust.

Even if an OEM is successful in its efforts to research and fund device development, it still has to navigate the many Food and Drug Administration requirements before commercialization can happen.

So how do we create the right environment for success, where success is defined by the positive impact to the patient? Is there such a thing as ‘innovating efficiently’?


Accepting the Innovation Challenge
In this changing medical landscape, I believe some of the fundamental questions around innovation center on risk. Questions like:

Who bears the responsibility for patient safety when it comes to accelerating the commercialization process for medical devices? Is it the brilliant minds in academia? Is it the corporate innovators that are changing the world? Is it the government, acting as champion of the people? Or is it the patient herself, now that her connected device can help her access treatment with the swipe of a screen?

I look forward to trying to answer these questions and others as part of our Manufacturing Innovation panel discussion at MEDTECH 2015, on October 14th and 15th in Buffalo, NY.

I hope to see you there!

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