The Benefits of Prototyping When Manufacturing Medical Devices

First off, it is important to note the fact that the prototypes Flexan produces may not be the only prototype of a medical device created. In fact, most of the OEMs we partner with have created much cruder or more primitive prototypes of the medical device before they come to us. Most likely, they will use different materials than Flexan uses, and the initial versions may not even be fully functional.  

For many of our partners, once they have created a few prototypes for themselves and have a design they feel will work, they reach out to us. Since we must always consider Design for Manufacturability, we’ll partner with the customer and start our prototyping process with tooling that is close to being production representative. As far as we’re concerned, the sooner an OEM reaches out to us, the sooner we can prototype the medical device or component, help recommend materials, or study the product from a DFM perspective. That allows Flexan to suggest changes early in the development process that will make assembly smoother and thus less costly. We can also help make suggestions for packaging decisions.  

Prototyping is an iterative process. Developing prototypes, delivering them to customers for Design Verification testing, discussing any necessary changes with the customer, making adjustments, then building another prototype, may happen three or four times. With Flexan holding DFM firmly in mind, we work with our partners to ensure the best processes before moving onto IQ/OQ/PQ validation, production, assembly, packaging and release to market.  

Of course, we customize the process for every partner we have, depending on their needs. All of us involved want to ensure we have a top-quality medical device or component brought to market that will innovate and improve the lives of patients.  

As you can see, beginning the entire manufacturing process with a prototype is crucial and is beneficial in the long run. However, here’s a list of benefits to prototyping you may not have considered:  

1. The process allows for adjustments before the expense of manufacturing. Making a change after the medical device or component has gone, or nearly gone, to market, it can be very difficult and very expensive.  
2. Prototyping saves money on rework. Like the above, getting the prototype right limits the amount of rework when the device is ready for assembly and production. This can end up saving a lot of money and time in the long run.  
3. It helps with innovation. When you can see, hold, touch, and functionally test a prototype, you might find innovative ways to improve it. Innovation is such a key part of the medical device creation process; this can help our partners lead the market.  
4. Quick turn prototyping improves speed to market. Flexan specializes in things such as rapid extrusion, but can also help create prototypes faster, so we can deal with issues fast, and we can help speed up the time from assembly to market.  
5. Ensures an accurate manufacturing process. When you are considering DFM, making a prototype means you can spot problems which might crop up during that manufacturing process. When those are spotted quickly, we can make adjustments.  
6. Ensures production feasibility. Sometimes a great idea just cannot be properly and effectively produced. Prototyping will determine that very effectively.  
7. Ensure regulatory compliance. The FDA and other global regulatory agencies have strict rules regarding medical devices. Prototyping will spot potential issues toward getting approval and bringing the device to market early enough to make changes.  
8. We can correct flaws shown in the design early in the process. Spotting flaws early is key in saving money, reducing rework and mitigating issues that might derail a product getting to patients.  

Flexan’s decades of experience in medical device manufacturing means we’ve had to make a lot of prototypes. Let’s look at a recent example of a time when prototyping the medical component was vital to ensuring innovation made it to market.  

Flexan was working with a partner who manufactured an at-home medical device, and they made the product in question from PVC. They have a desire to move to a reusable product rather than a disposable. The customer identified silicone as a fit for this application. Since silicone is one material Flexan specializes in, and we can develop prototypes even for extrusion projects, we felt we could uniquely help this customer.  

Since they intended the device for home use, it came with some unique requirements. It had to be durable, since the user would drag the silicone components around the house. Plus, there was a requirement for the machine in which the silicone components were being stored that presented some challenges.  

By prototyping, we were able to work with our partner to test key components. For example, we provided samples to test the abrasiveness of the material. Samples were also used to test durability for home use. All of this could be done well before our customer goes into mass production and ultimately brought the medical device to market.  

Still have questions about Flexan’s prototyping process? Curious about how we can help you bring an innovation to market faster and cost efficiently using our prototyping process? We have the answers you need and the sooner we can become involved in your project, the better. 

Reach out to one of our sales reps today and we can start the discussions about your medical device right away