Your Top 5 Questions To Matching Materials For Minimally Invasive Devices
Protecting Your Material, Application & System
By Rebecca Phan (July 2022)
With patient care becoming more precise, healthcare technology has been moving to minimally invasive solutions and miniature medical devices. Those in the medical profession and their supply partners need the right parts to make sure care is efficient.
Materials that are used in critical parts can make an impact on patient outcome, especially when working with miniaturized products and the mechanical properties that are involved. If a material is selected but issues are not uncovered until later, time and money are then wasted.
In order to help you with material selection, Jean-Marie Lebrun, our technical platform leader, has compiled this FAQ.
1. What trends are impacting the medical device industry and its material selection?
Miniature motor seals used in powered surgical tools are growing in popularity. These motors have long life and wear control requirements. Surgical tools have also grown smaller with handheld sizes, so they need to be lightweight for ease of use and ergonomics. Market trends for wearables 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.
It is important for materials used in these medical devices to have long life and wear; therefore, many of the polymer materials used such as our Rulon® fluoropolymers offer low coefficient of friction, provide excellent wear and abrasion resistance, and handle pressure ranges for many of the applications.
2. What important factors do you see device manufacturers overlooking when it comes to material selection for a minimally invasive device?
Device manufacturers should rely on proven material expertise from their partners in order to find the right option and specific to the working environment. You should always request data specification sheets for solution drawings. The right material is selected due to verified testing or prequalification by a research and development team and facility. Proven businesses like Omniseal Solutions 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, so it is important to not overlook this aspect. Materials often have 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.
3. How do device makers approach you when they need help with minimally invasive devices??
Device makers come to us with a material already in mind for a minimally invasive device or they come to us with necessary properties for their application. Customers may have already conducted their own research on materials and then ask us about our Rulon® or Meldin® material properties to see if these solutions will fit 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.
4. Are medical device manufacturers open to new materials for minimally invasive devices or are they seeking proven offerings?
The majority of proven options are evaluated along with tested results and specifications. Since time is a factor, most design engineers prefer to move quickly with their development; therefore, existing materials are selected. However, since our business is continuously improving our material offerings, we have several ongoing initiatives to go beyond in regards to temperature, pressure, speed, material compatibility, and wear limits. These properties are critical to solving some of the challenges and requirements that will be seen in the future.
5. Where are minimally invasive devices/technologies headed and how will materials make an impact?
The life science industry is clearly heading towards miniaturization and increased tool functionalities in order to improve maneuverability, access, and precision during surgeries. Advanced polymer compounds and composites provide unique materials properties such as low friction and low wear. When used with very high precision manufacturing, these end solutions will allow higher design flexibility and integration of miniature motors. In addition, new manufacturing technology in the form of high precision machining, 3D printing, and micro-injection molding will allow for rapid prototyping, faster design iterations, and manufacturability of advanced designs. This will ultimately simplify overall device architecture.