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 influence all stages of the development. They impact everything from the process to the plan and the requirements. You need to consider their influence at the earliest stages of the development effort.
This series focuses on the definition and execution of product development activities post-funding and includes the following:
- Idea – Without it, nothing to be developed
- Process – The structure for development
- Plan – The blueprint
- Requirements – The details
- Regulatory/Reimbursement – Critical to the medical device space (The article you’re reading.)
- Verification/Validation – The right product doing the right thing
For the purposes of this article, I’ve included regulatory and reimbursement together, but they impact the product in very different fashions, particularly when international markets are considered.
How to handle regulatory
Let’s first consider the regulatory impact on the product development process. While I’ll use the U.S. and the FDA as the example, virtually every other market in the world has some form of regulatory body that impacts the medical product development process. The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation. They are also responsible for advancing public health by enabling medical innovations and by helping the public get the information required for the use of medicines and foods for the maintenance and improvement of health.
First, what constitutes a medical product? Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as:
“… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals … [or] intended to affect the structure or any function of the body of man or other animals.”
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