As health data continues to become increasingly available, opportunities are arising for the use of data to support medical device decision making. FDA has recognized this and is creating new paradigms to use real-world data (RWD) to support regulatory decision-making for medical devices.
RWD sources such as registries, EHRs, and administrative healthcare claims databases provide information relating to patients’ health status and/or the delivery of health care that is routinely collected. RWD may be used as real-world evidence (RWE) to support a variety of FDA decisions. Examples of uses include post-market studies, expanding indications, control groups, supplementary data, and objective performance criteria and performance goals.
The key to using RWD, which may become RWE, is to ensure the reliability of the data. FDA suggests two aspects to consider: data accrual methods and data quality control assurance. FDA will consider the reliability of the data before using it to inform decisions.
To learn more, feel free to read the FDA guidance document: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical devices. Or feel free to contact one of our knowledgeable consultants at KAS.
Over the years, we have worked with many small companies who are interested in developing medical devices. Eventually, these companies encounter the regulatory paradigm established by the Food Drug and Cosmetic Act and/or the Medical Device Directive. Hopefully a first encounter with these regulations is part of a business plan, but sometimes this is not the case. We have seen regulatory issues present themselves at unfortunate times, for example while seeking venture capital funding. Sometimes a company is caught off guard after receiving an FDA Warning Letter, informing a company it is unknowingly marketing a medical device.
An in-depth understanding of medical device regulations is not necessary; however, a basic understanding is critical if you work in the industry. Here are a few book suggestions for any medical device professional, all of which provide indispensable knowledge for an entrepreneur.
Although slightly outdated and concerning a broader array of business topics than medical device regulations, The Entrepreneur’s Guide to a Biotech Start Up is an excellent resource for entrepreneurs and medical device professionals. The book’s chapters on “Device, Diagnostic & Instrument Models,” and “Medical Device Approval” provide a wealth of information that is presented in a clear and concise manner. The author, Dr. Peter Kolchinsky, also recommends a few resources under “Recommended Reading” which are also worth checking out. The best part about this book is that it is free!
Dr. Christopher Joseph Devine has published a handful of books that he brands “Devine Guidance.” These books are extremely helpful for understanding the basics of the Medical Device Directive and FDA’s CFR Part 820 (Quality System Regulations). Warning: the author’s use of third person and lame jokes can be annoying; however, his explanations are invaluable. If you need a crash course in Quality System Regulations, Dr. Devine’s books are for you.
Design Controls are critical for a small company to understand. Marie B. Teixeira published an excellent and practical book called Design Controls for the Medical Device Industry. This book assists in the development of an effective design control program, and it includes templates that can be used by a small company. The book is slightly outdated and does not include information on Unique Device Identifier (UDI) regulations. This book is great for medical device engineers.