By Bret Ludwig, Ph.D. Senior Product Development Specialist, 3M Medical Materials & Technologies
Great medical devices start with an idea—a spark. And from there, it might move to the back of a napkin or a notepad. But as development continues, the process can get trickier and more complex. In fact, turning an idea into a full-fledged medical device is downright challenging. You might have some starting blocks to put plans in motion, but it is important to consider all of the possibilities, from material selection to clinical trial design to manufacturing decisions, and forecast the process as much as possible. Keeping the following tips in mind can help you stay on the right path as you move from concept to launch.
Phase 1: The core concept
Go beyond the “What” and get to the “Why”. Curiosity is a key step in creating a people-focused design. Keep in mind how a variety of people might live their everyday lives when using your device, and from there, you can understand what your device is trying to achieve. For example, if you are designing a continuous glucose monitor to help manage diabetes, the “why” behind the device might be: to help those with diabetes live healthy, fulfilling lives. Throughout prototyping, testing, and manufacturing always keep the “why” in mind if you face any ambiguities.
Talk to a cross-functional team. Work with research scientists, sales, marketing, technical services, and others to brainstorm, ask questions, conduct research, and try to ensure your design and manufacturing will support your device’s goals. It can be helpful when the experts you engage have listened to customer needs and complaints. They can share insights based on what potential end-users have experienced. Remember, pain points and challenges can inform the device design remarkably. For example, if your device has a stick-to-skin component, having a deeper understanding of your intended end-user and your device requirements will help determine what characteristics your adhesive needs to exhibit.
Phase 2: Pliable prototypes
Fail fast and fail forward. When you are prototyping, time is of the essence not only to get to the end product but also for your budget. Having a nimble, rapid prototyping process can make tasks easier down the road. The faster you can iterate, the faster you can optimize your solution—and if you find you cannot manufacture it, move onto the next concept. Anytime it might seem like a “failure” early on with your prototyping, try to turn it into an opportunity to make your device better.
Keep manufacturing in mind. As your team decides which prototypes to move forward with, make sure to discuss manufacturing early and often. Not all materials and device constructions are suitable for mass production. Devices constructed from incompatible materials can fall apart prematurely or perform in unintend ways. Bench testing of a device can provide a lot of useful information for moving forward. It can help determine which prototypes are most likely to meet the device performance requirements, and with proper bench testing, you can feel more confident when you head into clinical trials.
Phase 3: Thorough testing
Test with the end-user in mind. Medical devices are not created in a vacuum. Even if you have prepared for any possibility, there can still be surprises. It is essential to test the safety of the device and its components with end-use conditions and keeping your end-user centered in each decision. For example, if a device has a stick-to-skin component, this can mean incorporating different skin types, different climates, and so on into the test design. Further, these considerations are also an important component for any regulatory requirements you might have, depending on your intended market.
Test the final version. Those who go beyond testing a prototype to incorporate the desired manufacturing process can discover potential design pitfalls. If the material cannot be processed repeatedly, you might have to look into other options. It is better to know this sooner than later, so you are not too far along your development process to make cost-effective changes.
Phase 4: Final scale up and launch
Transition from the lab to real life. Take the time needed to transition from lab equipment to the full manufacturing line. Although you can produce good preliminary specifications from lab equipment, it is not a directly transferable process. Have your product requirements top of mind and vet them against your product’s variability and expected range. Then you can have a better understanding of what is possible.
When the time comes, understand your process, relearn the process controls, and qualify the equipment. Compare production rates and process controls to ensure adhesives and coatings are applied as intended. The sooner you can flag issues as they arise, the sooner you can mitigate and solve for them. If problems persist, it is important to pinpoint where the breakdown occurs and why. It can be helpful to communicate with your multi-disciplinary team to resolve these issues.
Distilling the medical device development process in one article is impossible, but these tips can set you on the right path to a successful project. Luckily, bringing an idea from mind to market is not something you have to do alone. If you’re interested in finding out more—and how 3M can help you throughout the entire process.
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