ARTICLE FOCUS

• Selecting partners
• Choosing materials
• Determining manufacturing path

The design and manufacturing path of implantable PEEK components can prove critical to the success of any medical device. Many companies have struggled with these efforts in the past, causing PEEK to gain a reputation as a difficult material to work with. The truth is, working with implantable PEEK materials is not difficult as long as one follows a few simple rules, asks the right questions, and involves the right companies with the proper experience and expertise. This approach can make designing devices utilizing PEEK much more straight-forward. Here are 10 tips to help guide the process of launching an implantable PEEK device:

1. Follow the supplier's lead
Every material supplier has a detailed processing guide and many have excellent technical support to aide in proper material selection, design, manufacturing, and regulatory support. Such support is too often not utilized effectively. Be sure to take advantage of the learning tools and knowledge that suppliers have to offer. Read each suppliers design and manufacturing guides and be sure that both you and your processor follow them as closely as possible.

Suppliers also have experience in dealing with processors, often getting a great overview of processor successes and struggles as OEMs implement PEEK materials. It’s important to use as many resources as possible in seeking out qualified and capable processors, so be sure to ask for your material supplier’s opinion and recommendation. Don’t assume that because someone says they can mold implantable PEEK, they are actually capable. Do your homework to avoid selecting an incapable processor.

2. Take care in choosing a material supplier
At first glance, one might conclude that all PEEK materials are made equally. When looking at the physical properties, general biocompatibility, range of materials, and general overall performance of the materials offered by the differing implantable PEEK suppliers, little or no difference is readily observed. However, there are some underlying features, expenses, and support offered that differ greatly between available suppliers.

Selecting the wrong PEEK supplier for your application can jeopardize the overall success of any given project. As is the case with any medical device, speed to market is critical. A 510(k) path is much quicker and always less costly than going through an IDE/PMA approval. Therefore, when selecting a proper supplier of implantable PEEK materials, first consider the depth and breadth of the FDA Master File offered by the supplier. Differing suppliers have vastly different device records utilizing their respective materials. If a materials supplier has had a customer who has been successful in getting a similar device FDA approved, the chance to get a 510(k) approval based upon substantial equivalence is much greater. The ability to access a supplier’s 510(k) Master File can be crucial to obtaining a fast device approval or an approval at all.

In addition to the FDA Master File availability, it is also important to consider the quality of the supplied PEEK material. Inconsistencies in material supply can lead to potential quality issues, which can impact the perception of your device in the marketplace and create biocompatibility risk concerns. Important questions to ask any PEEK supplier include:

• Is there a secure and consistent supply of pre-curser materials?
• What quality controls are in place for the production of the material? What properties and characteristics are tested and included on the material certification?
• What regulatory support is offered when the device is submitted for FDA approval?
• What supporting application specific data is available?
• What technical support is available through the design, development, and manufacturing phases?

Asking these and other simple questions can help identify the right supplier for your device.

Finally, in choosing a supplier one must consider the cost of material. How much per pound of resin or per length of rod does the supplier charge? Does the supplier require milestone payments, per part royalties, FDA Master File access fees, etc.? Likewise, how does the supplier manage material supply? Are they willing to sell directly to contract molders and machiners? These less obvious costs can have a great impact on your bottom line. Keep in mind that the implantable PEEK market is getting more competitive by the minute, and pricing and overall costs of doing business with suppliers are likely to continue to change. Be sure to ask the right questions and choose a supplier carefully.

3. Ensure that you choose the proper grade of material
For most applications, standard unfilled PEEK resin grades will suffice. However, within the family of implantable PEEK polymers, a number of material grades exist, all with differing properties aimed to fulfill various application specific niches. Some examples include high-flow materials for the injection molding of thin-walled or micro-sized components, carbon-fiber-filled materials for increased strength or wear resistance, and barium-sulfate-filled materials, allowing for implants to be readily visualized on a multitude of imaging methods.

Understanding the benefits and specific details of each of these available grades can help differentiate products from those already on the market and ensure that implants provide optimal performance and benefit to surgeons and patients alike. Last month’s issue of Medical Design (page 41) included a broad overview of the available PEEK material grades and their benefits. Refer to this, as well as material suppliers who can provide more in-depth information regarding their material grades offered, often along with supporting biocompatibility data and application specific data for their materials. Doing your research will help determine the proper grade of material for your application.