How’s it going Core AndreC here. Recently I’ve started doing some freelance for a softgoods medical based product startup. I was originally brought on to do some concept dev for future products, but now they have me working on their launch product. Right now we are in the process of grading via several potential manufacturers. I have some knowledge about what the process entails, but I’m pretty new to the softgoods world. Does anyone have any insight about the process and how it is done?
Actually, it is going to mostly depend on what class of medical device it is. Soft goods likely are Class 1 or 2. I don’t think I have seen a soft goods Class 3, but never say never. Once a class is determined, is it 510K exempt or not? It is likely to be exempt, but not always.
The class and your FMEA will drive your specification. The specification will drive the QTPs for production and incoming. As the “engineer”, you will be responsible for determining the QTPs, but you should be getting guidance from your regulatory and legal departments.
If your product is not a device, the FMEA will drive your specification alone. No different between hard goods and soft goods really, just different forms of failure. For example failure at a stitch seam versus at a knit line.
Thanks for the reply iab. The product is Class 1 and is similar to a weighted vest that Occupational Therapists use with patients. I’m not sure on the 501k exempt status, though. QTP meaning quality testing protocol?
If your product is very similar to the vest and is not “new”, it is likely 510K exempt. You really need your regulatory and legal to make that call, not me.
But in my haste in replying yesterday I forgot to say you may need design controls and GMP. Or, you could be exempt from design controls and GMP. Again, that is up to regulatory/legal, but those will also have impact on your quality testing.
For example, one project we have is class 1, 510K and design controls exempt, but is not GMP exempt. We had to write and undertake lengthy QTPs (yes, quality testing protocols), to validate the GMP process. Probably added 6 months before we can actually test the concept on patients. And when we make a change, we will need to change the QTP and validate it for that change. Slow process.
Again, I forgot to mention something. There are very few, if any, soft good OEMs out in the world that are GMP certified. While we didn’t look extremely hard, we did look and didn’t find a source who would make our project.
I had no idea the impact legal could have on the design process wow. Thanks for the knowledge you have definitely opened my eyes to a lot of things.
Welcome to the world of medical devices.
The objective of regulatory is quite simple.
- Safety - You have to document that the product you specified is the product you made.
- Efficacy - You have to prove your product fulfills its claim.
You are currently in safety mode. How can the device fail? What are the risks of failure? How will the device be made to prevent failure? Prove all devices are made in such a manner.
Are the studies for medical devices made public at all? I’m wondering if I can find some for reference.
I have some experience working for a Class 1 medical soft good company. I’m not sure if you’re asking about the FDA approval process or “grading” as it relates to taking a development sample in one size and making the size range for the product line. The approval information can be found on the FDA website. FDA approved manufacturers can be sourced or the factory may find it agreeable to pursue an FDA license if your business warrants the time and expense. Depending on your plan, I’d look for vendors already manufacturing medical soft goods with similar construction methods and materials that your design requires. If you or the company is truly new to the process I recommend taking a hit on the cost and sourcing locally to overcome communication and logistics barriers.
If you’re looking at grading your sample, and it’s a brand new design without an antecedent , you might consider sourcing products that are similar in fit and function to use as patterns to develop the range of sizes you’re pursuing. This will cause some back and forth with the factory to finalize the fit and function for each size so plan your schedule accordingly. Hope that helps.
Thanks Steve, it’s been a bit of slow battle to convince the founders of the startup to move production into the states. Right now they have a crazy date in mind for when they want the product to launch. I’m trying to convince them that a launch in May isn’t really realistic. Currently, we have both patterns for males and females made to what they are calling a medium according to the freelance fashion person they hired. The manufacturer we are working with is saying at most 2 weeks to grade all of the sizes and then another 2-4 weeks to make a tool for rf welding.
Thankfully the company did pursue and get a FDA license so that does make some things a bit easier.
I know 510K clearances are on the FDA website and they provide a little of the information a company must give. I don’t know if you can see the application itself, I doubt it, but I’m not in regulatory and don’t need to research it. Thank god.
But if your device is 510K exempt, you won’t find anything similar as there is nothing to submit.
But class 1 is usually 510K exempt. I’d worry much more about being GMP exempt. If you aren’t, kiss your May launch goodbye.