Top 5 Medical Device Industry Trends in 2018: Atypical Medical Device Technology Will Become More Typical

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.

Documentation Must Be Comprehensive, Conclusive and Recorded

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.