Your entire project can be going smoothly, but then by the time it gets to the manufacturing stage, you find that there’s one part (or even multiple parts) that are suddenly unavailable. This causes a lot of frustration and tension, and leaves you to wonder what to do and whether your product will even make it to market.
As long as medical devices are being developed, innovators will face part obsolescence. While you can never quite prepare for it, you can be mindful of it; if it does happen, you can work with your medical device partner to come up with a backup plan.
Defining Part Obsolescence
What exactly is an obsolete part? An obsolete part is one that’s not manufactured anymore. It’s either because (1) demand for the part has drastically dropped, or (2) materials and technologies needed to make the part aren’t available. Either way, obsolete parts put you in a tough spot, placing you in a race to find alternatives so you can manufacture your device and get your device to market, just like you’ve been planning to do from the start.
Why Part Obsolescence Is a Big Deal
The medical device development process is long — years long. So imagine being close to the finish line, at the point where you’ve chosen your manufacturer, placed your order, and are waiting for the manufacturer to complete your order so you can launch your product. But then, you’re contacted and told that the parts required to make your device aren’t available anymore, and you’re left to figure out what to do next, now that your parts are obsolete.
As frustrating as this is, it’s always been a part of medical device development because the medical device industry relies on a supply chain that was made to support a changing industry. However, the medical device industry itself is slow to change; it’s not looking ahead to potential changes that arise from innovation, demand, or current events. On top of this, those in the medical device industry don’t have much control over supply chains because their volume of manufactured goods is much lower than other industries.
The pandemic has only exacerbated the problem of part obsolescence, with business operations and global supply chains heavily impacted by COVID-19. Because the “U.S. Food and Drug Administration’s Devices Program is responsible for the regulation and oversight of a wide range of medical devices that patients and their health care providers use every day,” the FDA is now working to help prevent medical device shortages (FDA). Since that improvement has yet to be seen, those working to launch their medical device are still struggling with part obsolescence.
… Now What? What to Do When Your Parts Are Obsolete
If you don’t want to completely scrap your medical device idea (and if it’s gotten to the manufacturing stage, you probably don’t want to!), you’ll need to replace the part that’s been named obsolete, which can cost you a lot, both in resources and time. It’s also incredibly stressful, considering that there’s the possibility of gapping out supply before you’ve secured your solution. If you’re working with the right medical device development team, part obsolescence will slow you down, but it won’t stop you from launching your device.
A good medical device engineering company will help you rework the original plans so you can redesign your device with more contemporary parts that are still being manufactured. If you do have to redesign your device, then it’s a good idea to include design-for-manufacturability (DFM) and other cost-improvement activities that justify the expenses.
Don’t Let Obsolete Parts Stall Your Project!
In most cases, you really can’t do anything about the fact that your parts have been named obsolete. However, you don’t have to let part obsolescence keep you from completing your project. From start-ups to major corporations, our team at C3 Medical Device Consulting is helping companies keep their projects moving despite part obsolescence.
To maintain your competitive edge and get your device to market, contact us today!
