Lower Cost Medical Devices? FDA Wants to Help
Can the U.S. FDA help medical device manufacturers reduce cost and increase quality? Medical device manufacturers are dealing with some of the most difficult challenges to ever face the industry. In an increasingly global environment, as competition intensifies, manufacturers must innovate and capitalize on new opportunities and expedite time to market.
To deal with these imperatives, medical device organizations are working to:
Increase product quality;
Meet stricter interpretations of regulatory requirements;
Increase the rate of product innovation;
Raise product safety and effectiveness; and
Decrease time-to-market and time-to-profit.
These challenges are exacerbated by the organizational structure and technological state of many medical device manufacturers and their interactions with the U.S. Food and Drug Administration (FDA), part of the Department of Health and Human Services.
For years, device manufacturers have sought transparency into production information, processes, and resources. Companies have looked for the ability to unlock the operational data to empower decision makers—from operators to plant managers and corporate executives—to make informed timely decisions.
Economic and regulatory shifts are poised to catapult shop floor systems into a key role to meet these challenges.
Historically, the typical interaction between FDA and Medical Device manufacturers involved the creation, printing, and review of volumes of paper documents. These documents may have been part of pre market approval (PMA), 510k applications, or reviewed onsite in the course of a Quality System Regulation (QSR-21 CFR Part 820) inspection.
|FDA suggests that one product lifecycle ties to the next and that each point in the lifecycle connects to every other; therefore, information flow is critical. The model seeks to integrate the complete product lifecycle by providing a holistic view of the process.|
Over the last few years, FDA has recognized that to continue to carry its mission in the 21st century, the agency needs a modern, well-integrated, reliable, efficient and affordable electronic information infrastructure to support FDA administrative, regulatory, and business operations.
To achieve this transformational goal, the agency has embarked on a series of organizational and information technology activities. These initiatives are aimed at advancing ongoing electronic communication and interactions between the agency, the public, and FDA-regulated companies.
The FDA is “actively moving toward an electronic world where all regulated product information comes in electronically,” whether it be related to product quality, manufacturing, pre-market, or post-market data, says Dr. Armando Oliva, FDA deputy director for Bioinformatics (in the Jan. 6 post of “Life-Science Panorama” from Axendia.) With the proliferation of manufacturing systems that provide for electronic device history records (eDHR), medical device organizations can shift to “exception only” eDHR reviews, where records are reviewed by question/answer and meetings are needed only in the event of a non-conformance.
At some point in the near future, this could extend to web-based reviews of electronic batch records with the agency.
The total product life-cycle (TPLC) is the centerpiece of the FDA’s Center for Devices and Radiological Health (CDRH) strategic plan. CDRH’s stated vision is to ensure the health of the public throughout the “Total Product Life Cycle—it’s everyone’s business.”
Through the TPLC, FDA has encouraged device manufacturers to transition away from the rigid product lifecycle processes (like the waterfall model) to the more suitable TPLC model (See diagrams).
This model seeks to integrate the complete product lifecycle by providing a holistic view of the process. In TPLC, product development is iterative and incorporates the required interactions between stakeholders as well as the contribution and input of each group involved in development. A TPLC approach focuses on sharing information among product lifecycle stages and, by extension, among departments and for future generations of product.
Also read from Axendia, FDA-related white papers:
– The Future of the FDA: Operating in an Electronic World ;
– Quality Management System Trends in Life Sciences ; and
– Pursuing a Future Where all Regulated Product Information is Electronic, interview with Dr Armado Oliva, FDA Deputy Director, Bioinformatics .
|Daniel R. Matlis is president of Axendia, a life-sciences and healthcare consulting and strategic advisory firm.|
21CFR Part 807 device advice from FDA
FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. Manufacturers who must list devices with FDA under Medical Device Listing – 21CFR Part 807 include:
Contract manufacturers that commercially distribute the device;
Contract sterilizers that commercially distribute the device;
Repackagers and relabelers;
Reprocessors single-use devices;
Manufacturers of accessories and components sold directly to the end user; and
U.S. manufacturers of “export only” devices.