DRW Monthly
July/August 2009
Issue No. 32

Stanford University Researchers Publish Medical Device Product Development Model

Researchers participating in Stanford University's BioDesign Program have developed a comprehensive model to explain the medical device product development process. In an effort to improve medical device company performance in executing the bench-to-bedside product development process, Stanford researchers have created a model based on best-practice analysis and interviews with more than 85 seasoned experts actively involved in the development, commercialization, regulation, and use of medical devices.(1)

Study results published in the June 2009 issue of the Journal of Medical Devices establish that regulations drive a significant portion of the product development process. The speed with which a medical device can reach the market is impacted by how quickly companies can fulfill the appropriate regulatory requirements. Manufacturer compliance with FDA's Quality System Regulation plays a particularly substantial role in this process and ensures the public that safe design practices are being followed. It remains a challenge, however, for device manufacturers to comply with these standardized regulatory requirements while simultaneously advancing innovation and streamlining their processes as creatively as possible.

The model itself is presented in a linear form with five major phases and four decision gates as follows: 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. It is applicable to both developers of complex and high-risk premarket approval (PMA) and premarket notification (510(k)) devices as well as to manufacturers of more simplistic devices exempt from most regulatory requirements.

Medical device manufacturers are unquestionably facing greater burdens during the product development process due to the recent explosion in technological advances coupled with stricter regulatory requirements. To say nothing of the medical reimbursement considerations that must also be factored into the decision-making and development process. Depending on the type and complexity of the technology, the device development process can take anywhere from 15 months to several years.(2) Given these challenges, it appears that Stanford's BioDesign Program and programs comparable to it, may play an increasingly valuable role in facilitating more efficient medical technology development by fostering collaborations between academic experts, industry innovators and regulatory advisors.

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