Medical Device Prototypes

Genesis’ comprehensive capabilities for converting medical polymers into stock shapes, film and components give customers quick turn-around on prototypes for technical and commercial validation of new material formulations and medical device designs.

Why are prototypes essential to medical device production?

The medical device industry is expanding at an incredible rate, and many startups are looking to compete with their device designs. However, long before that design can be brought to market, it must first be tested to satisfy regulatory agencies as well as the medical professionals that will utilize the device.Medical prototypes are an essential part of this process for a few reasons. For example:
  • Medical prototypes reveal potential safety concerns: The human body poses a difficult environment for designing devices. It is common for an initial design to present one or more safety issues. Often these issues aren’t evident until there’s a prototype to inspect. As medical devices are heavily regulated, addressing any and all safety concerns and documenting the process by which it is done are essential to meeting those regulations.
  • Medical prototypes improve cost efficiency: Although it is costly to create a prototype, in the long run a prototype can lead to the most favorable cost of production. That’s because during prototyping, polymer conversion specialists monitor which parts of the process can be improved upon and made more efficient on output and cost. Every device design iteration also can have different processing parameters. As a result, even when there’s a good plan in place to process a prototype based on prior experience, there’s typically room for improvement. That equals cost savings for the device designer.
  • Medical prototypes facilitate the design iterative process: It’s not just the production process itself that can be improved upon. It’s rare that a device’s initial design is the one that makes it all the way into full-scale manufacturing. Minor adjustments made as the final design develops can make a measurable impact in performance, durability, or comfort. Without a physical prototype to study, it is far more difficult to spot these opportunities to improve the design. Also, once into full-production, any potential improvements can be far more costly and require a supply interruption to implement.
  • Prototypes from an experienced converter can facilitate regulatory review: The FDA and other regulators will consider a device’s prototype history when reviewing a device for market approval. It’s imperative that device designers find a polymer converter experienced in this field to handle the prototyping and maintain the required records to facilitate the review process.

How can polymer conversion specialists assist with medical prototyping?

In recent years, polymeric biomaterials have become a frontline option for an impressive array of medical devices, including those intended for applications for spinal fusion, cardiovascular, orthopedic, arthroscopic, trauma fixation and dental markets. Polymers are also a top option for surgical instrumentation and lab equipment. In short, medical device startups are increasingly looking to polymer conversion specialists for their device prototyping and manufacturing needs. Here is why that’s a good idea:
  1. Polymer conversion experts can formulate an optimal production strategy: Experienced polymer converters have the kind of expertise that medical device startups need to get production started properly. This includes understanding which polymer is appropriate for the device design, selecting the best production methods and configuring all production equipment for optimal efficiency. The medical device industry is extremely competitive. Product introduction timing can be critical, and working with a polymer converter who has expertise in materials from day one will expedite the design-to-manufacturing journey.
  2. Polymer conversion experts can develop useful medical prototypes rapidly: The faster a prototype can be created, the sooner necessary changes and improvements can be made. To serve the medical device industry effectively, capable and experienced polymer converters will have the equipment capacity and know-how to produce prototypes on demand. By partnering with the right polymer converter, medical device startups can quickly iterate through several prototypes to reach their final design faster.
  3. Polymer conversion experts give device designers access to the equipment, materials and skills they need:
    Perhaps the biggest hurdle for medical device designers is accessing the equipment and raw material they need to prototype and manufacture their products. The outright purchase costs for production machinery and the operational staffing expertise needed is often prohibitive, especially for smaller startups. Also, it is often difficult to obtain the required materials in the small prototype quantities and timeframe required without having a working relationship with the raw materials supplier. For these device makers, it’s a common choice to outsource most if not all of the process to a polymer conversion specialist.
Experienced converters focused on this industry are accustomed to working with device designers in this capacity and can tailor their services to meet the needs of their clients. If a device maker requires assistance only in prototyping, a medical products conversion expert can do that. If a device maker requires a converter who can do everything from sourcing the raw material to creating prototypes, manufacturing the devices and packaging them, those capabilities are also available.In practice, a polymer conversion specialist serves as the gateway to getting a device to market for many medical device startups.

What kinds of medical prototypes can polymer conversion specialists produce?

The short answer is any kind of prototype that a device designer requires. If a device designer needs only preliminary prototypes, a polymer converter can generate these quickly. Once the device is past the early stages of designing, a polymer converter can produce more detailed prototypes, including alpha or beta prototypes.It is common for the design process to go through multiple iterations before the final design is settled. At every stage, a polymer converter can manufacture prototypes that are cost effective and facilitate the design-improvement process. For example, while final prototypes must be manufactured from the same material as the eventual manufactured product, polymer converters can help their clients save money by producing earlier prototypes out of less costly material. It is possible, for instance, to prototype a device using standard-grade PEEK instead of medical/implantable grade PEEK. The material properties of each PEEK polymer grade are very similar, but standard PEEK is less expensive because it is not produced according to the specific regulatory requirements for processing medical-grade materials.Further, an experienced polymer converter can use one of several conversion processes to create prototypes. Genesis Medical Plastics, for example, utilizes injection molding, machining, extrusion, and other, more esoteric processes such as film calendaring to create reliable, safe devices. These processes can be used in concert with each other to develop an array of prototypes, so the device’s design and most efficient production method are considered from every possible angle. Medical device manufacturing is a complex process from design to shipping, and along the way, several prototypes are usually required to ensure the device’s design is on track. The polymer conversion specialists at Genesis Medical Plastics are experts in this area, and work with clients to produce these prototypes in a cost and time-efficient manner.
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