Biocompatible materials

« Back to Previous Page
27
0

I've been trying to find a list of materials approved for implant by the FDA with little luck. Can anyone...

Please to read the entire article.

Marked as spam
Posted by Elizabeth Doyle (Discussions: 1, Comments: 1)
Replied on March 28, 2018 12:00 am
1 views
0
Private comment
FDA doesn't approve materials. It approves finished medical devices. The fact FDA approved a medical product made of a particular material doesn't mean it will approve another medical device made of the same material. However, you would normally put materials used to make a device very similar to yours, especially in intended use, high on your list of materials to consider for use in your device.

If you are hoping to clear the device via the 510(k) process, you will also want to keep in mind that a difference between the materials used in your device and your claimed predicate may get scrutiny from FDA as a difference in technological characteristics that is could "raise new questions of safety and effectiveness."

Marked as spam
Posted by Julie O. (Discussions: 8, Comments: 316)
Replied on March 28, 2018 8:00 pm
0
Private comment
I agree with Julie here. Furthermore, how the materials are put together, assembled, melted/soldered, manufactured, etc. can affect its biocompatibility (even strength, etc.). This is why there's a need to a test again even if the materials are the same if the special/critical manufacturing processes are different between similar products.
Marked as spam
Posted by Clarisa Tate (Discussions: 0, Comments: 5)
Replied on March 29, 2018 8:00 pm
0
Private comment
Elizabeth suggest you talk to a biocompatibility test house such as Wuxi or Nelson or look at the material in your predicate device.
Marked as spam
Posted by Robert Steele (Discussions: 0, Comments: 1)
Replied on March 30, 2018 8:00 pm
0
Private comment
Elizabeth,
I think I understand what you are asking. The responses above are on target. I’ll suggest looking at USP Class V and Class VI materials, again depending on your device. You may also look at aluminum. You may also look at titanium rods inside plastic. On biocompatibility, I’ll add Geneva, NAMSA, and Toxikon. I hope this helps. Good luck.
Marked as spam
Posted by Courtland Imel (Discussions: 0, Comments: 4)
Replied on March 30, 2018 8:00 pm
0
Private comment
Elizabeth, in my past I’ve dealt with this issue. While I agree with the other answers, my perspective is to look at the materials that have a Master File on file with the FDA. as I remember these list raw materials that have past biocompatibility testing. I think of this as a screening step; “at least there is a chance my finished device, with all its particular manufacturing processes, can be biocompatible without performing every biocompatibility test”.

Hope this helps
Marked as spam
Posted by Roger Hill (Discussions: 0, Comments: 1)
Replied on March 31, 2018 8:00 pm
0
Private comment
Rodger, that's exactly what I'm trying to find. Do you know where exactly to find materials with Master Files? Or how to search for them? I'm mostly getting results for drugs, not for materials.

Thank you everyone else for your answers thus far. I'm going to clarify my question.

Marked as spam
Posted by Elizabeth Doyle (Discussions: 1, Comments: 1)
Replied on April 1, 2018 8:00 pm
0
Private comment
Look for materials that have a Master file with the agency and if you want a lab that knows what they are doing call Exponent in Philly! Brilliant minds work their and connected to Drexel University! Another place is Analytical Answers in Woburn, MA
Marked as spam
Posted by Brian Callahan (Discussions: 0, Comments: 1)
Replied on April 1, 2018 8:00 pm
0
Private comment
Master Files are not publicly available files and the owner of the file has to give the FDA permission to access the information when they are reviewing a submission. It is a way of companies providing confidential information to the FDA for them to review when one of their customers is filing for a device using that material. It is not information that anyone can use. The information in the files is also not reviewed or "pre-approved" by the FDA.
Marked as spam
Posted by Andy Carter (Discussions: 0, Comments: 1)
Replied on April 1, 2018 8:00 pm
0
Private comment
Hello Elizabeth. If you are looking for a polymer I suggest you check Solvay’s portofolio. They have MAF in place for a variety of polymers. Please contact me directly if you need contact information.
Marked as spam
Posted by Alexandre Delemazure (Discussions: 0, Comments: 1)
Replied on April 1, 2018 8:00 pm
0
Private comment
Have you considered metal powder injection molding?
It's a similar process to injection molding that produces a sintered metal part.
Advantage being the process is well studied for use with titanium and life critical parts (implants) have already been produced.
There's a good introductory article on it available on open access if you're interested. Has graphs of tensile strength and discussion of fatigue.
http://www.mdpi.com/1996-1944/6/8/3641/pdf
Marked as spam
Posted by Tony O'Neill (Discussions: 0, Comments: 1)
Replied on April 1, 2018 8:00 pm
0
Private comment
Hey Elizabeth... the answer also depends on the end use of the product.

For dental - Titanium alloys, Cobalt Chrome, Zirconia ceramics, Gold, and Bioglass have been used and generally accepted as biocompatible

Orthopedic - Titanium alloys, Cobalt Chrome, Stainless Steel, Alumina, some Polyethylene, and PEEK material

Cardio - Titanium alloys, Nitinol, Gold

But you also have a host of biomaterials, scaffolds, xenographic or allographic materials, combination products, synthetic and natural materials and applications i didn't mention (contact lense, neurological and audio implants...etc)

If you define the application, it will be easier to get a master list of materials that have a track record of biocompatibility for that end use.
Marked as spam
Posted by John Sharobiem (Discussions: 0, Comments: 1)
Replied on April 1, 2018 8:00 pm
0
Private comment
Hi Elizabeth, I’m a polymer scientist with experience in materials processing and properties for orthopedic devices. At Lucideon, we also perform biocompatibility testing, test method validation and performance testing for FDA submissions. Please connect if you would like to discuss further.
Marked as spam
Posted by Richard Padbury, Ph.D. (Discussions: 0, Comments: 1)
Replied on April 2, 2018 8:00 pm
0
Private comment
Elizabeth, a different application needs different materials. You can use table 1 from EN 10993-1 standard to see the nature of body contact, duration etc. Most of the implants need the expanded list of testing according to 10993, initial material biocompatibility is important. Keep in mind that manufacturing processes and even sterilization could affect it. Titanium, PEEK, ceramics and stainless steel are the most common for orthopedic, trauma and dental implants.
for 3D printing, there are such materials as GelMa, collagen, gelatin...
Marked as spam
Posted by Anastasia Tas (Discussions: 0, Comments: 2)
Replied on April 2, 2018 8:00 pm
0
Private comment
The question you need to answer is: What materials (metals or polymers) will fulfill the strength properties of titanium in my application? Once you have answered that you can search for USP Class VI polymers as substitutes. The existence of a Master File does not always resolve the issue, in most cases the resin manufacturers sterilize the resin in one way for biocompatibility testing, and you might be doing it in another way requiring you to do further testing. The manufacturer is responsible for establishing biocompatibility for the desired / specific indication.
Marked as spam
Posted by Umit Yuksel (Discussions: 0, Comments: 1)
Replied on April 2, 2018 8:00 pm
0
Private comment
Hi agree with both Anastasia and Umit your question is not a list but a analysis of materials vs properties vs biocompatibility & FDA approval. I am involved in Post Graduate Research into Implants and am a Supervisor in Biomed Engineering feel free to chat to me re Titanium Implants and alternatives the current move is towards Ceramics however other materials are also being utilised strangely not all have Material properties of Tinanium such as strength but are being used in very novel ways PEEK is one of these examples
Marked as spam
Posted by Marc Slabbert (Discussions: 0, Comments: 4)
Replied on April 3, 2018 8:00 pm
0
Private comment
hi , SABIC has a list of APPROVED MATERIALS specially created for medical applications and they are all injection mouldable.. pls check sabic website
Marked as spam
Posted by Suresh Chandrashekaran (Discussions: 0, Comments: 1)
Replied on April 4, 2018 8:00 pm
0
Private comment
Suresh, approved by whom?
Marked as spam
Posted by Julie O. (Discussions: 8, Comments: 316)
Replied on April 5, 2018 8:00 pm
0
Private comment
Hi Elizabeth,
For US FDA, any device needs to have it's biocompatibility validated (justified,) even if the material has been used before by your company. It can be really tricky to establish the existence of a "predicate" from another manufacturer.
For an implantable device, the biocompatibility evaluation will have to consider "physical characterisation" including surface topology, etc. in addition to chemistry.
Also, It is not very realistic to think one can just "drop" a new material into a device. the only material that has the same properties as Titanium is: Titanium, and processed in the same way! The material, design, and processing all need to be considered in order to realise a device.
To get you started, as you mentioned injection moulding, I'd advise you consider PAI and PEEK, probably from Solvay in the first instance.
Marked as spam
Posted by James Morrison (Discussions: 0, Comments: 1)
Replied on April 6, 2018 8:00 pm
0
Private comment
3M documents and markets their material data sheets & specifications very well. They would be a valuable resource to determine if a material is /isn't suitable for the application.
Marked as spam
Posted by Mike Stratis (Discussions: 0, Comments: 1)
Replied on April 7, 2018 8:00 pm
0
Private comment
Approved materials are those which were filed through master-files to the FDA
The materials I know are: UHMWPE, Titanium 4-6, SS, Ceramic (Alumina Zirconia), PEEK, PI (MP-1), Tantalum
Marked as spam
Posted by Alisa Buchman (Discussions: 0, Comments: 1)
Replied on April 8, 2018 8:00 pm
0
Private comment
Dear Elizabeth,
There isn’t such a “List” that exist for Biocompatible material…wishful thinking. Each manufacture has the flexibility to choose the best material for the device to be able to perform and manufacture at a scale to generate revenues with due consideration to COGs, however the manufacturer has the responsibility to demonstrate the biocompatibility of not the materials used but the final finished product/ device. Simply put, manufacture should not just take “like for like” approach for the materials used but should consider the processes that the material undergoes during the product realisation and then evaluate the biocompatibility as per ISO 10993 which is a recognised consensus Standard by the FDA.
Please contact info.raqs@gmail.com for any further information.
Best of luck.
Dev
Marked as spam
Posted by Dev Raut (Discussions: 0, Comments: 1)
Replied on April 10, 2018 8:00 pm
0
Private comment
Hi, Elizabeth. Zeus works with a number of polymers that have predicate use in a wide array of implantable applications. We'd be happy to better understand your specific requirements and assist in identifying suitable materials with appropriate regulatory history and supporting biocompatibility data. Please reach out at your convenience.
Marked as spam
Posted by Josh Ridley (Discussions: 0, Comments: 1)
Replied on April 11, 2018 8:00 pm
0
Private comment
Alisa Buchman - a master file isn't a materials approval - it's just a mechanism for the material manufacturer to protect their IP by sharing confidential detail only with FDA and not with their device manufacturer customer.

They file with FDA a dossier of technical data (aka Master File), usually including physical and biological testing data. FDA will put it on the shelf unreviewed.

Then if a device manufacturer comes along with a submisson to FDA for a device using that material, they get a letter from the materials manufacturer granting permission for the FDA to review the master file data in support of the device application.

Materials manufacturers sometimes charge a (not insubstantial fee) for master file access - so recovering some of their costs in developing the data.
Marked as spam
Posted by Arthur Brandwood (Discussions: 1, Comments: 1)
Replied on April 11, 2018 8:00 pm
0
Private comment
Hi Elizabeth,

You’ll need to do some homework, first make a list of all the properties of the currently used material and then split them into essential and desirable.

Once that’s done, you could approach specialist polymer companies such as RTP group, Covastro etc

Polymeric materials will contain a number of additives too and hence you’ll need chemical characterization as well as leachability information, ideally in the type of environment you wish to impart. Specialist company may advise tweaking their formulation effectively giving you a “designer material”.

Finally, you’ll need to carry out biocompatibility study and stability study on the finished product.

I hope this helps
Marked as spam
Posted by Champa Patel (Discussions: 0, Comments: 1)
Replied on April 12, 2018 8:00 pm
0
Private comment
Definitively PEEK. Potentially thermoplastic like POM depending on your application. No database in my knowledge except a list of recognize or forbidden color agents. Regards - stanislas
Marked as spam
Posted by Stanislas Achard de la Vente (Discussions: 0, Comments: 1)
Replied on April 12, 2018 8:00 pm
« Back to Previous Page