The two “Vs” — also known as V&V, verification and validation — serve to link the medical device product that has been developed all the way back to the initial customer needs and product requirements. Bill Betten, Betten Systems Solutions While many think that verification and validation only occur at the end of the medical device development […]
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Medical device startups: Here’s how you handle regulatory and reimbursement
The two “Rs” — regulatory and reimbursement — are critical elements of the environment in which a medical device product is developed. Bill Betten, Betten Systems Solutions This is the fourth in a series of articles that discusses the design of innovative products in the highly regulated medical environment. But the “environmental” factors of regulatory and reimbursement actually […]
Medical device startups: Here’s how you successfully plan
The development of the product development plan is an evolutionary effort that continues through the life of the medical device project. Bill Betten, Betten Systems Solutions, and Tom Waddell, Waddell Group This is the second in a series of articles that will discuss the design of innovative products in the highly regulated medical environment. The first […]
Medical device startups: Here are the secrets of success
Bill Betten, Betten Systems Solutions It’s tough enough to be a startup developing and launching innovative products. For medical device startups, there’s the added burden of operating in a highly-regulated industry. The cost of developing a medical device ranges from $25 million to $100 million, according to a 2010 research study out of Stanford University. […]