But to reach your business goals, your product can’t be designed in a vacuum. After all, even the most innovative designs will only be successful if they’re also compliant and manufacturable. That means your product’s path to commercialization begins with the very first design choice. And it’s impacted by every subsequent decision that’s made along the way.
As a leading medical device design and contract manufacturer for four decades and counting, MPE Inc. knows first-hand the challenges OEMs face when products aren’t designed with compliance and manufacturability in mind. That’s why MPE Inc. acquired Mindflow Design to augment and strengthen our in-house design capabilities.
This strategic acquisition enables us to apply the best of design and development expertise to our comprehensive capital equipment commercialization platform — taking your next product smoothly from ideation to launch.
Why product development shouldn’t be linear.
Many OEMs think about product development chronologically. Design comes first, and manufacturing comes last. But on this one-lane, one-way road, reaching the ultimate destination of product commercialization often takes longer — and costs far more — than companies anticipate.
Why? The most critical medical device decisions occur during the design stage. And since design choices compound as time goes on, one ill-fated decision early in the process can lead to significant (and sometimes insurmountable) challenges when it’s time to engineer and produce your concept.
Where siloed product development processes fall short.
Say your company wants to create a new device for diabetics to administer their insulin shots. A traditional product design firm might focus solely on the usability needs of the typical end user and design a solution that checks off the boxes of your PRD. But they might not factor in:
- The potential user needs of non-patient users such as caregivers and healthcare workers. These can vary significantly from the needs of users who self-administer their medication.
- Ways to differentiate your product from similar products that are already in the market.
- How to source the components that make up your device, and the ongoing per-unit cost implications of custom versus off-the-shelf parts.
- Whether or not your product’s total cost will meet the price point your market demands.
- What it will take — and what it will cost — to manufacture the product to scale, especially if certain design choices require custom tooling and form factors.
Furthermore, run-of-the-mill designers may not understand how and when to properly document their design choices, the results of usability testing, and other key pieces of information to comply with the strict guidelines of various regulatory bodies. This could cause further delays when it’s time to apply for the necessary regulatory approvals.
The bottom line is this: In a linear product development process in which different vendors handle different parts of the process, you might not uncover the ramifications of seemingly straightforward design choices for months, even years. And you may not realize your product is unmanufacturable or noncompliant until you hand a completed design from one vendor to the other.
Discovering issues at this late stage may require you to go back to square one, which could cost you time and money — not to mention your competitive advantage.
The power of a multi-lane product development superhighway.
Rather than thinking about product development as a step-by-step process, MPE Inc. approaches it as a multi-lane superhighway. Our medical device commercialization platform allows multiple workstreams to move forward simultaneously — merging and intersecting in a coordinated, iterative fashion.
For example, working in parallel on the hypothetical insulin injection device mentioned above, our multidisciplinary team would:
- Conduct comprehensive research to understand latent and unmet user needs.
- Create an initial design concept and prototype for early human factors usability testing.
- Document CAD drawings, early concept work, and usability testing results for compliance purposes.
- Analyze the results of usability tests and incorporate feedback into additional prototypes.
- Keep an eye on market trends and conduct ongoing competitor analysis.
- Assess the setting where the product will be utilized to ensure it will function as intended.
A look at MPE Inc.’s control planes.
On any superhighway, it’s essential to keep traffic moving forward at a steady clip. But it’s also necessary to put safety protocols in place to prevent accidents and pileups. At MPE Inc., we use three control planes to guide our product development efforts and ensure we keep your project moving in the right direction. These are:
- Differentiation
- Market adoption
- Compliance
We’ve touched on the importance of differentiation and compliance already. But let’s break down the market adoption control plane to see how it might work in practice.
A design firm that focuses solely on designing a stellar product may not consider how the power supply functions within the context of the product’s environment. That, in turn, will affect market adoption.
But the Mindflow Design team — now MPE Inc. — has extensive experience in the MedTech space. As a result, when considering how to power the device, we would explore questions like:
- Where will this medical device be utilized? Will it be used in a busy ER? Wheeled around on a cart? Carried from room to room?
- Is a power cord appropriate for this device? Will it create a tripping hazard or contribute in any way to unsafe working conditions?
- Is a battery-powered solution feasible and desirable? What’s the best way to ensure technicians can easily charge, replace, and dispose of batteries?
Yes, this is a simple, straightforward example. But it illustrates how far-reaching even the simplest design choice can be.
By offering design, engineering, compliance support, and manufacturing under one roof, MPE Inc. uncovers and mitigates issues early — and ensures your path to commercialization is as quick and cost-effective as possible.
Take a unified approach to developing your next MedTech product.
Medical devices should always be designed in a human-centered, user-oriented way. But even the most beautiful, user-friendly designs won’t deliver the market impact you’re looking for unless they’re differentiated, compliant, and manufacturable.
That’s why MPE Inc.’s acquisition of Mindflow Design is such a significant value-add. By integrating conceptualization, design, compliance, and manufacturability on a nimble capital equipment commercialization platform, MPE Inc. delivers a unified approach to product development that leaves nothing to chance.
Are you ready to learn more about what our comprehensive suite of services can do for your next product? Let’s talk.