Matching Minimally Invasive Device Trends with Material Selection—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief
 
Virtually all of healthcare is moving to minimally invasive solutions, with devices getting smaller. This can add complexity to product development projects. As such, OEMs are leaning on their supply partners to help ensure they have the right parts and have made the correct decisions to ensure success.
 
Material selection is one of these critical decisions that need to be made. When working with miniaturized products, that choice is even more important to be certain the necessary physical properties are provided. If an unsatisfactory material is selected and the problems don’t emerge until much later, a tremendous amount of time and money would have been wasted.
 
To help ensure this process is performed properly, Jean-Marie Lebrun, technical platform leader at Omniseal Solutions, Saint-Gobain, responded to a number of questions about this topic. In the following Q&A, he addresses a number of questions around material selection and many factors that play into the decision.
 
Sean Fenske: What minimally invasive device trends is Omniseal Solutions, Saint-Gobain seeing that impact you most?
 
Jean-Marie Lebrun: We’ve been working recently in miniature motor seals used in powered surgical tools. The motors have long life and wear control requirements. Surgical tools are also smaller and handheld, so they need to be lightweight for ease-of-use and ergonomics. Market trends for wearables also include minimally invasive, lightweight, and long-life requirements. Some newer research and development projects require miniature seals for intravenous pumps used for different therapies running continuously for a set time.
 
Fenske: How are these trends affecting the material selection process?
 
Lebrun: Materials need to have long life and wear so many of our Rulon® fluoropolymer materials are used, which offer low coefficient of friction, excellent wear and abrasion resistance, and handle pressure ranges for many of the applications.
 
Meldin® thermoplastics are used for small bearings and components used in pneumatic surgical motors. Meldin offers high thermal resistance and good mechanical properties at high temperatures.
 
Fenske: What important factors do you see device manufacturers overlooking when it comes to material selection for a minimally invasive device?
 
Lebrun: Device manufacturers rely on our knowledge of materials for the right option for the product environment. They’ll ask for data specification sheets for product drawings and their internal paperwork. However, we usually choose the right material, which is tested or can be prequalified by our research and development team and facility. We also offer simulation services to define how material and product design will perform. In life science, Class VI and/or FDA-approved materials are often specified and approval processes may be lengthy. It is important to not overlook this and we have certified several material options to answer most requested needs. Materials have often unique processing methods associated with them, which will greatly influence volume capability and manufacturing costs. It is therefore important to accurately estimate the volume at maturity of the application so the most cost-effective material and process is chosen—right from the beginning.
 

Fenske: Do device makers come to you with a material already in mind for a minimally invasive device or do they come to you with the necessary properties and seek your guidance? Either way, how do you assist them?
 
Lebrun: Both scenarios; customers may do their research on materials and ask about our Rulon or Meldin material properties for their applications. In almost all situations, we ask for more information—cycles, speed, and/or lifetime needs; temperature; fluids/media; hardware type and surface finish; and pressure. There may be more environmental questions that need to be answered, but these are some of the important questions to determine the best material for co-development design. In miniature devices, obviously the available space and dimensional specifications are important. In some instances, flexibility on the hardware design is helpful.
 
Fenske: Are medical device manufacturers open to new materials for minimally invasive devices or are they seeking proven offerings?
 
Lebrun: Primarily proven options are evaluated as they present with tested results and specifications for them are available. Most design engineers would like to move their development along quickly, so existing materials are preferred. However, we are continuously improving our material offerings and we have several developments underway to keep pushing the temperature, pressure, speed, material compatibility, and wear limits of those.
 
Fenske: Where are minimally invasive devices/technologies headed and how will materials facilitate that direction?
 
Lebrun: Miniaturization and increased tool functionalities are clear directions taken by the industry in order to improve maneuverability, access, and precision during surgeries. Unique materials properties, such as the low friction and low wear of advanced polymer compounds and composites, combined with very high precision manufacturing, allow higher design flexibility and integration of miniature motors. New manufacturing methods, such as high precision machining, 3D printing, and micro-injection molding, allow for rapid prototyping, faster design iterations, and manufacturability of advanced designs, ultimately simplifying overall device architecture.

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?
 
Lebrun: Omniseal Solutions has more than 500 material options and an unlimited number of design options to satisfy a specific customer’s needs. Our experience in very demanding markets (e.g., space, aviation, life science) is unique and our simulation and testing expertise allows us to select wisely from our options, allowing for rapid innovations.
 
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