Leaders in Pharmaceutical Business Intelligence (LPBI) Group

New Medical Devices and Human Factors Implications

Curator: Danut Dragoi, PhD

Today medical devices become more and more sophisticated due to advancement in medicine as well as electronic technology and materials. New products that penetrates new markets have a human factor which is the acceptance of the product, that is determinant on shaping a growing market. Marketing people were working with the public, ultimately the buyer, through different channels, like industry presentations, advertisement, promotional free devices and samples, international conferences  etc. On the other hand, the buyer is supposed to have some knowledge on the news on medical breakthroughs as well as understanding their benefits for human health. The human factor discussed here  talks about the costs, investments, official requirements and materials information in medical device design. It is critical for the manufacturers of medical devices to align their production to FDA requirements before they become a factor on the pricing of the new product. The FDA 510(k) Human Factors Guidance is a key consideration for all companies in the medical device sector. The relationship between design control activities and human factors is shown in the table here. The risk analysis factor is mentioned three times in the table. It means that from concept to final product, the designer of the product has to accommodate tight requirements of not only high qualities but also right functionality that work properly and are thoroughly verified. In the reference here is discussed the improving medical implant performance through retrieval information from the users, designers, engineers, scientists, and experts. At the request of the National Institutes of Health’s Office of Medical Applications of Research, RAND company provided technical and historical background for the NIH Technology Assessment Conference on Improving Medical Implant Performance Through Retrieval Information: Challenges and Opportunities. RAND Issue Papers explore topics of interest to the policy-making community. In the report of RAND company it is mentioned that bio-materials provide components for many life-saving and life-enhancing medical devices, including implantable items such as heart valves, orthopedic prostheses, and intraocular lenses. U.S. firms produce more of such devices and hold more patents on them than firms from any other nation. However, manufacturers of these devices face a potential shortage of the bio-materials necessary to make them. Producers of bio-materials have in recent years cut off or restricted the supply of their products to the makers of implantable medical devices. The resulting uncertainty over the availability of commercial bio-materials, including “off-the-shelf” materials that are still used in other industrial applications, is likely to have a number of repercussions. In concluding remarks of RAND report it is mentioned that balancing the interests of the various parties in the bio-materials debate—injured patients, benefited patients, manufacturers, and researchers—and considering potential benefits and risks to future patients that may come from research (or the lack thereof) is complex. If the policy approach we use in striking this balance does not appropriately regard the interests of all parties, including current and future patients who could benefit from implantable devices, the overall benefit to the public could be lessened.