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.
This is very insightful. There is no doubt that there is the bias you refer to. 42 years ago, when I was postdocing in biochemistry/enzymology before completing my residency in pathology, I knew that there were very influential mambers of the faculty, who also had large programs, and attracted exceptional students. My mentor, it was said (although he was a great writer), could draft a project on toilet paper and call the NIH. It can’t be true, but it was a time in our history preceding a great explosion. It is bizarre for me to read now about eNOS and iNOS, and about CaMKII-á, â, ã, ä – isoenzymes. They were overlooked during the search for the genome, so intermediary metabolism took a back seat. But the work on protein conformation, and on the mechanism of action of enzymes and ligand and coenzyme was just out there, and became more important with the research on signaling pathways. The work on the mechanism of pyridine nucleotide isoenzymes preceded the work by Burton Sobel on the MB isoenzyme in heart. The Vietnam War cut into the funding, and it has actually declined linearly since.
A few years later, I was an Associate Professor at a new Medical School and I submitted a proposal that was reviewed by the Chairman of Pharmacology, who was a former Director of NSF. He thought it was good enough. I was a pathologist and it went to a Biochemistry Review Committee. It was approved, but not funded. The verdict was that I would not be able to carry out the studies needed, and they would have approached it differently. A thousand young investigators are out there now with similar letters. I was told that the Department Chairmen have to build up their faculty. It’s harder now than then. So I filed for and received 3 patents based on my work at the suggestion of my brother-in-law. When I took it to Boehringer-Mannheim, they were actually clueless.