Even the most innovative, user-friendly MedTech designs will only succeed if they’re compliant and manufacturable. That means your path to commercialization begins with your first design choice for your product. And it’s impacted by every subsequent decision that’s made along the way.
Leverage these five questions before you begin the design process to ensure your product is both user-friendly and manufacturable.
1. What materials will your product be made of?
The materials you use to create your medical device have direct implications on your product’s manufacturability and usability.
Materials like sheet metal, machine plastics, and injection molding have different ramifications regarding cost, time to market, and distribution. They also impact the user experience regarding weight, touch and feel, and ergonomics.
For example, if you choose sheet metal, your product will be more linear and boxy. It may also include sharp edges that could pose a safety concern. By contrast, injection molds give you more options to create an organic, user-friendly look and feel. But these are costlier and often require custom tooling.
Your choice of materials also influences how well your device adheres to your existing brand language. For these reasons, it’s crucial to consider the materials you’ll use long before your design reaches the manufacturing stage.
2. Will you use custom or off-the-shelf parts — or both?
Designing custom parts for your product may be the best choice if you want to differentiate your device from the competition and provide an exceptional user experience. Often, bringing an innovative device to life requires a new solution.
But before you go this route, make sure to count the cost. Custom parts require extensive testing and validation before the design ever reaches the manufacturing phase. Producing them at scale may also require expensive tooling and machinery.
On the other hand, sourcing off-the-shelf parts isn’t exactly a no-brainer. Existing devices like robotic arms have already been tested and validated and may be cheaper to source. But they may not always be widely available. And, since you don’t own that design, any changes the manufacturer makes to the part could impact your product in the future. Furthermore, existing parts don’t always satisfy your users’ unique needs in a way that truly sets your product apart.
3. How will you build serviceability into your medical device?
Many devices require users to service them on-site rather than return them to the manufacturer. Therefore, it’s critical to design and manufacture your medical device knowing it won’t always be fixed by an expert technician. If your product is too cumbersome for a user to access screws or cables, for example, the device’s overall user experience takes a hit.
To that end, think about your design from a manufacturing and serviceability lens before it’s actually manufactured. That way, you safeguard your product’s UX, giving your users the flexibility to service a medical device on the spot without causing them harm or disrupting their work.
4. Which safety and sanitation requirements must be considered upfront?
All classifications of MedTech devices must meet minimum FDA guidelines for product safety. Requirements will vary based on the product’s type and use cases.
Sanitation and safety go hand in hand, so as you design your product, consider what it will take to clean it and prepare it for reuse. This relates directly to question one regarding the materials you choose to use. For example, using hazardous materials such as hydraulic fluid may disqualify your device from being used in a sterile environment like an operating room. Materials like porous plastics may be harder to sanitize than smooth surfaces. If the device needs to be broken down to clean it properly, consider how components fit together and how easy it is for users to disassemble it.
5. What will it take to achieve ongoing regulatory compliance?
Designing a compliant medical device isn’t a one-and-done endeavor. Even after your device hits the market, there are ongoing safety and usability requirements to remember.
For example, if you’re completing a 510(k) submission, you’ll need to provide a list of critical product components that are serialized or otherwise traceable. This will require you to decide how to trace these parts long before manufacturing. If users must return a part to the manufacturer for service and/or recertification, there needs to be a process for them to follow.
Consider your user needs through the lens of manufacturability.
MPE Inc. is uniquely positioned to help you design a medical device that’s user-friendly and manufacturable. By integrating conceptualization, design, compliance, and manufacturability all under one roof, our capital equipment commercialization platform delivers a unified approach that leaves nothing to chance.
If you’re preparing to bring a new MedTech product to market, let’s talk.