Top Three Ways to Innovate with Biomaterials in Your Next-Generation Device

Engineer for the Device

1.The first thing to keep in mind is to engineer for the device, not around the material you have on the shelf. Before selecting a material, we must first understand how the device needs to function in the body, how the device can be delivered, or implanted with minimal complications. Here, speaking directly with physicians who are familiar with the relevant medical procedure can prove helpful. Physicians can offer suggestions on how they might like the device or delivery system to perform.

It is also a good idea to meet with experienced engineers familiar with the device and the procedure to see what they may have seen and tried in the past. Produce some prototypes and review them with the physician to ensure the design intent meets the design specifications. The things that seem "cool" may not necessarily be good for device performance or for the physician using the device. As engineers, we want to simplify current procedures, improve patient safety, and extend lives.

Be Consistent

2. Design the device with the same material at the start of the project. Devices should not be made with parts lying around in the R&D lab. The device design for a prototype should represent the function and materials for the final device design. For instance, it is hard to justify design intent using a nylon-based fabric when the device requires polyester. Nylon is softer; it will break down in the body. Polyester will not break down and it is a much more stable material. Polyester can be made into many different forms or structures. 

Consider the following scenario: an engineer, when developing a device or structure, uses an industrial-grade material in the development. The design works as intended. The company requires full traceability of all materials going into the device, which now requires a medical-grade fiber to be used in the manufacturing of the device. A test protocol, testing, and test report needs to be generated to make a material change mid-stream of the device design. This translates into a loss of time and increased expenses for the company. The correct yarn should be used in the design in the first place. Most companies do not have a budget to support every new idea that is generated. If the design that you are trying to create is approved in the budget and company plan, use the materials that will represent the final design. Collaborate with your suppliers to see if they will work with you on design intent and help you mitigate the feasibility cost, such as the RxFiber feasibility program.

Understand that One Size Does Not Fit All

3. Understand the materials used in the device assembly; one size does not fit all. Don't be tempted to overgeneralize or underestimate when considering the properties of materials. For example, RxFiber's RxFibronHT high-tenacity PET is an option for medical device companies interested in alternatives to UHMWPE. RxFiber is creating next generation-fibers that will help medical device companies create smaller devices, yet maintain strength. Fit materials to your ideal device outcomes.

The science and engineering of medical device textiles is complex. As such, most mechanical or biomechanical engineers lack a background in textiles for the devices requiring a textile material, and often ask their supplier to give them a fabric sample to help them with their prototype. Most suppliers of fiber do not understand the intent behind the device and/or lack medical device engineering experience. As a result, suppliers may end up providing engineers with supply scraps, off-the-shelf standard materials or overruns they may have lying around. Some engineers designing the device may think that all fabric is the same.

Consider this example: an engineer makes a prototype using a certain fabric. The prototype works in the lab environment. A prototype delivery system is made to support and deliver the device. But eventually, it is determined that the device will not fit in the delivery system. The root cause: the fabric was too thick, having the wrong polymer base, wrong density, wrong fiber size, and maybe even wrong structure.

It is important to understand all facets of the device. At least someone on the team with appropriate experience should be tasked with studying portions of the device and the materials. Do not assume your supplier understands your device and that you are ordering the right materials based on your suppliers' suggestions. You need to push back to understand what you may need to create the best device design. Source suppliers that have medical device expertise and that can help you select and manufacture custom material solutions. Take advantage of all the latest advancement in custom fibers to develop your next-generation device.

Contributing author Robert Torgerson is the president and founder of RxFiber LLC. The company opened a new facility in 2012 and is focused on production of custom medical-grade fibers produced under ISO 13485 standards dedicated solely to the medical device industry. 


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Society for Biomaterials 2014

High Tenacity Polyester: RxFibron HT - The New Generation of High Performance Materials

This Dr. Martin King, Professor of Medical Textiles at NCSU presents his comparative analysis research findings on biomaterials traditionally used in medical devices as it compares to RxFiber's RxFibron HT. The research results finds RxFibron HT has superior properties and characteristics as compared to standard materials in medical devices.

Rx Fibron HT Research Society For Biomaterials 2014