Changes Taking Place in the Manufacturing Sector
The food and drug administration (FDA) are the alpha and omega of the medical equipment sector. While companies try to work in the light and some do not many may be working in the dreaded grey area; the space between corporate purity and damnation due to ambiguous documentation. Now comes a change that will require compliance by all manufacturers. The Quality System Regulation is now being aligned to ISO 13485 to help it comply to the International Standards Organizations own standards. By doing so this will shift regulation review and amendment on the ISO while allowing manufacturers to more easily do business worldwide. While this does not appear to be good due to all manufacturers having to conduct system audits and adapting existing processes it is due to less paperwork for the majority of companies that may already need to follow ISO 13485. It is hoped that the FDA continues on this ISO alignment.
Interestingly the FDA may also be trying to change regulations relating to third party servicing and re-manufacturing of medical devices over safety concerns. At the moment servicing is more regulated than re-manufacturing, however both are causing some ambiguity. While servicing means repairing and maintaining the existing design intent, re-manufacturing changes the performance and safety of the initial design. In addition to FDA regulation changes in this area, the Right-to-Repair act proposed last year may further impact this area. This could mean a whole multitude of outcomes, from the original manufacturer becoming the formalized service provider and 3rd parties trained through the company to ensure servicing is conducting according to the maintenance intent of the design, to re-manufacturing not being an option for medical devices. As of yet we watch this area with baited breath because it will have a knock-on consequence to sells and profitability of contracts.
New Advances in Manufacturing
The FDA have been assessing the viability of Additive Manufacturing (AM) particularly during the Covid-19 pandemic in medical device applications and the industry waits abated upon that study. In addition, continuous manufacturing has been another interest area.
While AM is nothing new in the medical industry and limited to bespoke products, ‘impossible’ products that could not be manufactured using subtractive manufacturing processes and low production runs. Economies of scale for AM typically range from 1 up to 10,000 units depending upon application.
Continuous manufacturing in itself has been around for years and due to scales of production means your product should have the best unit price. The wooden coffee stirrers that you use for your coffee along with toilet rolls are produced continuously with manufacturing lines having online maintenance activities designed into the manufacturing process. At present rolling this out for various medical devices and high levels of cleanliness cause challenges. This may be solved by Edge remote sensors for automating maintenance flagging and auto-adjustment to production lines and work centres.
It is likely that continuous medical device manufacturing will be complemented by artificial intelligence (AI) for continuous quality control (QC) and maintenance activities.
Along with medical device manufacturing, medical device cyber security is also becoming of key interest to the FDA. This has been due to recent devices and hospitals being hacked showing life threatening actions by others need to be corrected for in design of the medical solution. This is the software equivalent to the need of adding security screws to pay phones to stop vandalism and product miss use. Products must work as intended; while this used to mean addressing physical safety concerns it now mean also addressing cyber security concerns.
The Future
Based upon these FDA activities this year looks like it will produce some operating headaches and some opportunities hand in hand. Medical equipment manufacturers can only wait and hope for a beneficial outcome, as change always breeds opportunity.
