IP AND TECHNOLOGY DEVELOPMENT

Interviews. The major findings of the report will be based on interviews with experts and practitioners involved in various aspects of medical device development and commercialization. The selected interviewees help to broaden the depth and range of the report, as suggested by the following characteristics.

• Interviewees represent each major functional group involved in device development: R&D, marketing, legal, regulatory, reimbursement, quality, clinical, manufacturing and operations, and sales.
• Subjects were chosen from both large and small medical device companies in various technology areas and geographic locations across the United States.
• Participants represent a range of industry experience levels, from employees with two to five years of medical device experience to top industry executives and serial medical device entrepreneurs.
• Interviewees also include leadership from FDA and CMS, angel and venture capital investors, intellectual property attorneys, physician inventors, and others.

The 80 interviews conducted as part of the study contain both qualitative and quantitative elements. Several in-depth interviews and surveys were conducted to obtain quantitative data that characterize the specific elements of the development process. Interview questions focus on the specific processes and procedures that companies have implemented, on the specific requirements and challenges of different types of technologies, and on potential areas for improvement, from both an internal company perspective and a public policy viewpoint.

Previous Models. The report will include a literature review of existing device and drug development models and of the current medical device regulatory process.

Classification. The report will offer a systematic classification of devices, showing similarities and differences among the development processes used for various types of devices.

Model Process. The report will present a core model of the medical device development process, including variations that explain the differences among various types of devices and innovation processes.

Concrete Examples. Case studies illustrate the development processes used for a number of distinct technologies.