The influx of technology companies outside of the health care sector developing medical treatment products has been going on for some time. This trend will likely continue to intensify the competition among all sectors of medical device development. However, in many cases, disruptive innovators will still need to rely on the industry “street smarts” of incumbent organizations to navigate the mazes of regulatory guidelines and requirements. There are nuances along the regulatory compliance pathway that could trip up non-traditional companies.
Manufacturing products in a regulated industry involves a significant amount of documentation. Nontraditional companies might not be aware that every syllable of research data, design concepts, storyboards, functional specifications, emails, meeting minutes and notes scrawled on a whiteboard must be captured in system records and made available to all the stakeholders.
In medical device manufacturing, all documentation must be tightly controlled. Some of the documents required during a medical device’s development lifecycle include: SOPs, calibration instructions, procedures, packaging and storage instructions, test plans and validation checklists. In addition to the actual documents, all documentation must include the accompanying metadata, such as who created the document, who checked and approved the document and data and the time-stamped status of the document. Delays in any part of document control can be detrimental – and costly.
Careful handling of the large amounts of documentation is critical for following good manufacturing and document management practices. Regulatory agencies have high expectations for document control processes, which includes procedures for approval, tracking, distribution and change management.
New device technology commonly requires healthcare providers to change their processes and workflows in order to use new devices. When new devices require training prior to use, it can further delay a facility from gaining the full benefit of the new device and process changes that come with it.
Disruptive medical device developers should consider pacing themselves with new device technologies. If demand for a new device is uncertain, it might not be worthwhile for a facility to incorporate it until the potential for cost and productivity benefits are more apparent.
Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), emphasize the importance of product safety, efficacy and quality. Satisfying regulatory requirements is important, but risk management in medical device development is not just about complying with regulatory standards.
Risk management is a total lifecycle process and should not trail off and become less of a priority once a product is implemented in the health care environment. Medical device manufacturers can learn a lot about their device during manufacturing and after it’s on the market – particularly regarding the pre- and postmarket risk and mitigation factors.
ISO 14971 is the normative risk management standard for medical device development. It outlines how risks are identified and quantified based on likelihood and severity. The FDA also recognizes ISO 14971. The FDA’s guidance on medical device risk management, “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions” cites, “Both ISO 14971 and 21 CFR Part 820 take a total lifecycle approach to management of risks identified after the device is on the market. There may be benefits to manufacturers incorporating ISO 14971 into their quality management system.”
The guidance further states that manufacturers need to create and maintain a comprehensive Risk Management File (RMF). The RMF should remain active and up-to-date throughout the device’s lifecycle, as postmarket data may show that a device’s risk is higher than anticipated. The RMF documentation includes all design, production and postmarket risk management activities and data. It should also include customer feedback, complaints and corrective and preventive actions (CAPAs).
The surge of medical devices and related technologies continues to expand the medical device playing field. Advances in technology will compel companies in all sectors to elevate their efforts in exploring new innovations. However, the compliance landscape is complex and regulatory inspections continue to get more detailed and thorough. Traditional and nontraditional medical device companies alike are recommended to be equally thorough with their quality and risk management processes.
David Jensen is a marketing communication specialist at MasterControl. He has been writing technical, marketing and public relations content in technology, professional development, business and regulated environments for more than two decades. He has a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.
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