Researchers at Stanford University have published a model representing the medical device development process in the June issue of the Journal of Medical Devices.

The model was constructed based on best-practice analysis and interviews with more than 85 experts involved in the development, commercialization, regulation, and use of medical devices.

“Medical devices contribute significantly to the continuous improvement of healthcare,” said lead author Jan Pietzsch, Ph.D.,consulting assistant professor in the department of management science and engineering at Stanford University. “Depending on the type and complexity of the technology, the device development process can take anywhere from 15 months to several years. As a result, successfully bringing innovative products to patients hinges on knowledge of and planning for this process.”

According to the authors, the developers of both highly sophisticated premarket approval (PMA) and premarket notification 510(k) devices use the model.

The five major phases and decision gates include:

• Phase 1/Gate 1: Initiation, opportunity, and risk analysis.

• Phase 2/Gate 2: Formulation, concept, and feasibility.

• Phase 3/Gate 3: Design, development, verification, and validation.

• Phase 4/Gate 4: Final validation and product launch preparation.

• Phase 5: Product launch and post-launch assessment.

Pietzsch added that the medical device development process has become increasingly complex in recent years because of the advent of advanced technologies, stricter regulatory requirements and the increasing importance of reimbursement decisions.

Among the key results of the study is a detailed explanation of the significant differences between medical devices and pharmaceuticals and the corresponding differences in their development processes and regulatory requirements.

Researchers also pointed out that the U.S. Food and Drug Administration’s quality system regulations don’t always permit product developers to streamline their processes where it would make sense.

Go to http://asmedl.aip.org/getabs/servlet/GetabsServlet?prog=normal&id=JMDOA4000003000002021004000001&idtype=cvips&gifs=Yes to view the abstract of the article published in the Journal of Medical Devices.