Suggestions for Textile Suppliers for use in Medical Devices

Mark Meer

Trusted Information Resource
#1
Wondering if anyone can suggest some suppliers that can offer textiles suitable for use in medical devices?

Specifically, we just want reliable companies which can offer a variety of various textiles we can sample. Once we select a suitable fabric for our purposes, we will confirm biocompatibility ourselves (according to ISO10993).

Because the biocompatibility tests are expensive and time-consuming, we'd like (obviously) to minimize the chances that we have to repeat these tests. Therefore, it is important that the supplier:
a) is well established (they're not going out of business anytime soon)
b) has a consistent product catalogue (so the exact same product can be consistently purchased)
c) (ideally) has a history of supplying textiles for use in medical applications (so we can be reasonably confident chosen product will not fail biocompatibility tests).

Can anyone suggest some?
(feel free to send me a personal message if particular endorsement of a company is not appropriate)

Thanks in advance.
MM
 
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M

MIREGMGR

#2
Are you making implants, or external-unbroken-skin positioners or garments, or something in between?
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Wondering if anyone can suggest some suppliers that can offer textiles suitable for use in medical devices?

Specifically, we just want reliable companies which can offer a variety of various textiles we can sample. Once we select a suitable fabric for our purposes, we will confirm biocompatibility ourselves (according to ISO10993).

Because the biocompatibility tests are expensive and time-consuming, we'd like (obviously) to minimize the chances that we have to repeat these tests. Therefore, it is important that the supplier:
a) is well established (they're not going out of business anytime soon)
b) has a consistent product catalogue (so the exact same product can be consistently purchased)
c) (ideally) has a history of supplying textiles for use in medical applications (so we can be reasonably confident chosen product will not fail biocompatibility tests).

Can anyone suggest some?
(feel free to send me a personal message if particular endorsement of a company is not appropriate)

Thanks in advance.
MM
Hi,

Focusing on the biocompatibility aspect for a moment -

Your approach is reasonable, but it's also somewhat limiting and/or a bit more risky. Either you end up with a well-established medical industry supplier, with a wider product range and higher prices, or with a niche manufacturer with all the right stuff and a limited range, or with a jack of all trades where the risk of eventual failure will be higher.

I would, instead, separate the evaluation into two aspects: The supplier should be evaluated for range, reliability, stability, reputation, quality system, commercials etc. etc. The product should be evaluated independently for various aspects, including biocompatibility. The latter can be quickly screened based on generics, then you can drill down through manufacturer reports, previous applications etc. Actual biocompatibility testing should only occur once you are confident re. both material and supplier.

You'd be surprised how many gross material selection mistakes could have been prevented if only manufacturers held an orderly evaluation at the generics level :(

Cheers,
Ronen.
 

Mark Meer

Trusted Information Resource
#4
MIREGMGR:
No implants as of yet. Just body-worn stuff. Looking therefore for stuff like cottons, nylons, polyesters, velcros, neoprenes...etc.
Like I say, we're not yet sure of the ideal fabrics... so it'd be nice to start with a known reliable, consistent & reputable supplier, and then request samples from there...

Ronen E:
The supplier should be evaluated for...reliability, stability, reputation...
I don't know how to go about this other than ask here at the Cove. I really don't trust company website testimonials/reviews or correspondence with marketing reps on this front...

The latter can be quickly screened based on generics, then you can drill down through manufacturer reports, previous applications etc.
I presume that by "generics" you mean reasoning such as: "cotton is widely used in body-worn applications, therefore it should be reasonably safe to assume that the cottons supplied by X are also safe."?
For a well-established supplier, maybe. But when it comes to niche suppliers, I prefer caution. No telling whats in colorants etc.

As for manufacture reports, these, in my experience, are scarce when it comes to textiles. Few textile companies actually test their fabrics, and even if they do, additional treatments such as dying might bring the validity of any reports into question...
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Ronen E:

{1} I don't know how to go about this other than ask here at the Cove. I really don't trust company website testimonials/reviews or correspondence with marketing reps on this front...



{2} I presume that by "generics" you mean reasoning such as: "cotton is widely used in body-worn applications, therefore it should be reasonably safe to assume that the cottons supplied by X are also safe."?
For a well-established supplier, maybe. But when it comes to niche suppliers, I prefer caution. No telling whats in colorants etc.

{3} As for manufacture reports, these, in my experience, are scarce when it comes to textiles. Few textile companies actually test their fabrics, and even if they do, additional treatments such as dying might bring the validity of any reports into question...
Hi Mark,

1. I wouldn't go into too much detail, because supplier evaluation was discussed a lot at Elsmar, have a look please. The obvious starting point would be your own QMS Purchasing Control procedures (should be aligned with ISO 13485, part 820 or the likes). Relating specifically to reputation etc. - ask the supplier for a referee list, then call a few and have a chat. If the supplier is a big org with a long history, there shouldn't be a problem with that. If they don't have such a list (or it's very short), or won't share it, or no one on the list is willing to talk to you - it's a red flag.

2. No, by "generics" I meant things like "Polyester", "Polyamide" etc., without reference to a specific grade. I don't have a lot of experience with natural fibres like cotton, but for synthetic materials you can find a lot of scientific evidence that can tell you whether the material is likely to be suitable. Query any dyes and additive in a similar way (FDA has specific regulations for colorants). Reasoning of the sort you noted is better left only as a last resort. The purpose of the "generic" stage is to quickly close in on a subset of materials, and rule out those that wouldn't fit, regardless of grade and/or supplier. I've seen companies struggle and waste a lot of money just to find the most suitable grade within a generic type that was clearly unsuitable in the first place...

3. This relates more to niche companies that deal mostly or exclusively with medical applications. Such companies would normally be aware of the important aspects, and if they elect to test, the reports are more likely to be appropriate. I agree it's rather rare, but if a company offers it, it's a big help and maybe even a reason to prefer that particular one. A lot of R&D engineers look for the best performing material and neglect aspects such as regulatory compliance and commercials; they come up with wonderful devices that can't be put onto the market without wasting a lot of time and $$$. I recall designing a device for a start-up company - we eventually chose a polymeric material that wasn't the best engineering fit, but it had biocompatibility reports available, and was commercially very stable and affordable. It ended up passing all functional / performance testing (was good enough) and regulatory clearance was so much simpler.

Cheers,
Ronen.
 
F

franck7727

#6
I would suggest Singbwo Enterprise from Taiwan, you can google them to check their website. They are present in big medical exhibitions such as Rehacare, IFAS and Medica. They supply many manufacturers of orthopedics supports, wheelchair cushions, etc

I do not work for them, but I know them coz I used to work in a medical exhibition company in Taiwan until recently (I'm still in Taiwan...).

At least it is something for you to compare with any other leads.

Fran?ois
 
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