Implantable devices come with an array of challenges, so gaining a helping hand (or two) in their development and manufacture can be a tremendous aid for OEMs. Leveraging the services and synergies of supply chain firms already accustomed to working together on these types of projects can really help move a project forward.
More specifically, working closely with a molding supplier and the material provider together, a number of advantages can be realized. When these companies have already established lines of communication, their engineers have previously collaborated, and they have several success stories to their credit, it may be in the OEM’s best interest to enlist the services of both organizations to maximize the potential benefits.
With this in mind, the following Q&A focuses on working with a manufacturing partner and their material supplier to help ensure a successful implantable product is produced. Kenny Freitag, commercial director—Advanced Components at Spectrum Plastics Group, a DuPont Business, and Allison Taylor, customer technical support engineer for Syensqo Specialty Polymers (formerly Solvay Specialty Polymers) responded to several questions around this topic.
Sean Fenske What types of implantable components and devices are Spectrum developing and manufacturing using Syensqo implantable materials?
Kenny Freitag: Spectrum is concentrating on the Sports Medicine area related to the fixation of ligaments or tendons. These components can either be permanent implants or temporary/resorbable implants. Spectrum does participate in other areas for implantable requirements, such as abdominal, ENT, trauma, and arteries, among others.
Allison Taylor: Many of the projects we have worked on involved small parts, sometimes with complex designs. Applications include cardiovascular, neurovascular, drug delivery, or dental applications using Eviva® PSU; implantable wire coatings using Veriva® PPSU; and orthopedic and spine implants fabricated from Zeniva® PEEK. Fortunately, our network of processors within the U.S and globally have experience with Syensqo high-performance materials. Syensqo engineers work closely with them to offer material expertise.
Fenske: When taking on a new implantable project, how soon do you enlist aid/advice from a material partner like Syensqo?
Freitag: Spectrum has vast knowledge of the requirements for material preparation and processing of implantable materials. We engage with material suppliers such as Syensqo SpP based on the need for the performance of the product. It is essential to engage the material supplier as early as the request for quote and Design for Manufacturability activities.
Taylor: As Kenny said, we have found it beneficial for both the OEMs and our processors if Syensqo is involved early. Syensqo offers expertise for material recommendation, material sampling (pellets and molded shapes for testing), regulatory support (e.g., ISO 10993, MAF with FDA, etc.), and virtual engineering to support the OEMs and our processors. These services create a streamlined process and limit the need for retroactive modifications later in the process (e.g., tooling modification, choosing a better-flowing material, etc.).
Fenske: How often do your respective engineers collaborate and communicate regarding a new implantable project?
Taylor: Spectrum and Syensqo have been working together for decades; the historical relationship allows us to work efficiently with the OEM to recommend materials and processes best suited for the applications. From there, it becomes an iterative process with the engineering teams and key account managers working closely together.
Freitag: Just to add to what Allison said, Spectrum is a major supplier to the largest medical device companies. We collaborate with both Syensqo and the customer during all aspects of a program regarding product development and manufacturing. We also engage in proof of concept through commercialization. With implantable applications having such specialized performance requirements, our engineers must engage and support our customers through all aspects of development. We truly view our relationships with our customers and material suppliers as partnerships.
Fenske: When the OEM customer comes to you with a project, do they typically have the material in mind or are they seeking recommendations from you and your supply chain?
Freitag: In the Implantable material selection process, most of our customers usually have a general understanding of the materials in question. Once a basic knowledge of material requirements is understood, we can support engagement with material suppliers to pinpoint the best material grade to be successful for the application.
Taylor: Mechanical properties, chemical resistance, flowability, transparency, and other factors are key elements considered during material selection. Syensqo engineers then select the best-suited material from the current portfolio of implantable materials available, which are Eviva® PSU, Veriva® PPSU, and Zeniva® PEEK.
Some OEMs have a material specified; however, if they do not have a material in mind, engineers from both Syensqo and our processing partners can collaborate to identify the best material based on the application’s requirements.
Fenske: Is your material supplier involved with selection and then drops off or do they continue to collaborate through development and manufacturing?
Freitag: Spectrum insists it is essential to keep the material suppliers involved for the entirety of a program. From the upfront material performance expectations, its anticipated processability, and the expected final product performance, the material supplier’s input is valuable. We may even seek advice for the regulatory submission. Dialog with the material supplier is essential throughout the total lifecycle of a program.
Taylor: Syensqo offers unique support, allowing us to assist our customers from concept to commercialization. Our support extends even throughout the product’s life, where we will be there to offer support on failure modes through lab testing or troubleshooting at the processors.
Additionally, Syensqo has a dedicated regulatory team available to answer questions, provide biocompatibility testing according to ISO 10993 and MAF access file letter upon request, and any other documentation required for FDA approval or other non-US regulatory agencies.
Our full healthcare-grade portfolio includes resins for surgical instruments and various healthcare applications allowing medical device companies to work with us for their entire systems.
Fenske: What unanticipated benefits are gained for you and/or the customer from close collaboration with the material supplier?
Taylor: Streamlined process of designing and manufacturing. There are two sets of engineers working to ensure the material is best for the application and processed most optimally. The options for processing methods are extensive. We work with a network of processors within the U.S. and globally, which allows our customers to receive the ideal expertise in processing our materials regardless of manufacturing location.
Freitag: Exactly. Our material suppliers are experts in their field. They are constantly developing new grades and making recommendations and material selections for various applications. All material suppliers have several grades available of similar materials. The selection of the proper grade based on performance requirements is critical for success. Our Engineering team gains tremendous knowledge on materials performance and how various processing parameters vary due to special formulations. We truly have a very tight relationship with all materials suppliers and firmly look at them as an extension of our team.
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
Freitag: To meet or exceed our customer’s vision and requirements, we need to have a three-legged stool approach. Each leg offers critical support to the success of a program—the customer for the vision and specifications; the molder for the manufacturing; and the material supplier for the product performance. One tight, cohesive team is of paramount importance.
Taylor: With over 30 years of experience providing high-performance polymers to the healthcare industry, Syensqo has the expertise and product portfolio that medical device and equipment OEMs require.
Click here to find out more about Spectrum Plastics Group, a Dupont Business >>>>>