Medical device and diagnostic companies face greater demand to provide clinical evidence of product efficacy than ever before. With increased scrutiny from regulators, healthcare systems, and even patients, more device companies are performing clinical trials to improve the likelihood of commercial success.
In today’s competitive landscape, device companies are facing increased demand for clinical evidence of product efficacy and safety. In addition to pressure from regulators prior to market approval, device companies must answer to other stakeholders, including:
- Payers who are requiring more information to substantiate product value claims to approve reimbursement
- Physicians and healthcare systems who are requesting more evidence to inform purchasing decisions
- Patients who are asking for increased transparency into the development process
This increased scrutiny has prompted more device companies to perform clinical trials to meet regulatory requirements, differentiate their products, and position their products for earlier adoption and success in the market.
Medical device trials must be designed to verify the performance characteristics defined by the manufacturer, determine undesirable side effects under normal conditions of use, and allow an informed assessment of the risk-to-benefit ratio in relation to the intended performance of the device. ISO 14155:2011 sets the international standard for good clinical practice in medical device trials, and a thorough understanding of these guidelines will help sponsors design and conduct studies that stand up to regulatory scrutiny. In this white paper, we examine best practices for the conduct of medical device clinical trials, the principles of which are defined in ISO 14155:2011.