Risk Sharing Agreements Medical Devices

Risk Sharing Agreements: An Emerging Trend in the Medical Device Industry

In the world of medical devices, every decision has life-and-death consequences. Whether it`s a life-saving implant or a diagnostic tool, the stakes are high, and so is the pressure on manufacturers to deliver quality products. That`s why risk sharing agreements (RSAs) are becoming an increasingly popular trend in the industry.

What is a Risk Sharing Agreement?

A risk sharing agreement can be defined as an agreement between two parties, namely the manufacturer and a third-party payer or reimbursement agency, where they share the financial risk associated with the use of a medical device. In essence, it`s a way for medical device manufacturers to share the outcome risks with healthcare providers to ensure that their products are being used effectively and efficiently.

Why are Risk Sharing Agreements Important?

RSAs offer benefits for both manufacturers and patients. For manufacturers, it helps to reduce the financial risk associated with the launch of a new product in the market. Failure to meet specific clinical or financial targets could result in substantial financial losses. In contrast, RSAs can help to mitigate this risk by sharing responsibility for product outcomes.

For patients, RSAs can lead to better access to innovative medical technologies. By sharing the financial risk with healthcare providers, medical devices become more affordable. This, in turn, makes it easier for patients to access innovative treatments that might not have been accessible otherwise.

Types of Risk Sharing Agreements

To date, there are three types of risk-sharing agreements used in the medical device industry. These are:

1) Performance-based agreements – these are agreements that focus on the clinical outcomes of a product. For example, a manufacturer may agree to provide refunds if a product doesn`t deliver the promised outcomes.

2) Coverage with evidence development (CED) – these agreements are used to secure coverage for a product by generating clinical evidence that the product works. Manufacturers and payers work together to gather data on a product`s effectiveness.

3) Financial risk-sharing (FRS) – these agreements are designed to share financial risk between manufacturers and payers. For example, if a product doesn`t meet specific financial targets, the manufacturer may agree to provide discounts or refunds.


Overall, risk sharing agreements are an emerging trend in the medical device industry. As the pressure to deliver high-quality products continues to grow, RSAs provide a way for manufacturers to share the financial burden while at the same time, improving patient access to innovative treatments. As RSAs gain in popularity in the medical device industry, we can expect to see more collaboration between manufacturers and healthcare providers to ensure that products being developed meet the clinical and financial targets set out in these agreements.