Designing a medical device and taking it to market is inherently risky. Without proper control planes in place, you could create a truly innovative product — even going so far as to secure FDA approvals — and still end up with a market flop. 

There are numerous reasons for this, three of which we’ll explore in greater detail here. But it boils down to this: Many OEMs approach product development in a siloed, sequential manner that fails to adequately factor in users’ needs. 

That’s why MPE Inc.’s unified commercialization platform — backed by design and manufacturing expertise — is so powerful. Our comprehensive ideation-to-launch pathway integrates user needs analysis, design research, manufacturability, compliance, and feasibility from day one to ensure our clients’ products have the very best chance of market success.

Here’s a look at three common mistakes that hold many medical devices back — and how our unified commercialization platform enables you to avoid them.

Mistake #1: Overlooking key market segments and user needs.

The success of any medical device project depends on understanding the various use cases for the device and knowing exactly when — and by whom — it will be used. Few OEMs would disagree with this premise. 

But the truth is many product developers oversimplify their user requirements and fail to consider all their users when they design a new product. Some don’t talk to users and instead look to their CEO, marketing team, consultants, engineers, and other internal stakeholders to define user requirements. Others focus on one group of users and overlook entire market segments and subgroups.

More often than not, this results in costly rework, manufacturing delays, a longer time to market, and — ultimately — poor market adoption.

The far-reaching implications of not meeting user needs.

Let’s say you plan to develop a new medical device for surgeons to use during surgery. Meeting the surgeon’s needs as the primary end user would, of course, be paramount. 

But if you only consider the surgeon’s needs, your design team might make choices that have a negative domino effect on manufacturability and market adoption.

For example, in response to a surgeon’s need for precision and control, designers might conceptualize a fully bespoke design featuring ergonomic contours and custom parts. The surgeon might love the design and find that it delivers superior results. 

But if you don’t factor in the users who will transport, assemble, disassemble, service,  and sterilize the device, you might design a product that:

  • Takes too long to set up and tear down, which in turn impacts how many surgeries can take place in a given day
  • Requires custom tooling, which can significantly increase initial and ongoing production costs
  • Includes materials that don’t adhere to safety and compliance standards, which could hamper or delay the FDA approval process
  • Is difficult to sanitize, which increases the provider’s risk of liability
  • Is unintuitive and easy to misinterpret, which can result in preventable usage errors 

There are dozens of additional considerations to factor in, of course — from the product’s footprint in the operating room to its serviceability and repair requirements. Get any one detail wrong, and clinicians may decide the device is more trouble than it’s worth. 

Design, manufacturability, and market adoption are inextricably linked, so MPE Inc.’s unified commercialization platform looks at them all in tandem.

Mistake #2: Waiting too long to test and validate your design.

Making changes to your medical device design after it’s in production isn’t merely inconvenient. It can blow your budget, significantly lengthen your time to market, and cost you your competitive advantage.

That’s why it’s absolutely vital to test and validate your design long before you reach the manufacturing stage. This might sound obvious, but it’s surprisingly common for product developers to interrupt the manufacturing process after receiving late-breaking feedback from users. 

For example, if early-stage testing isn’t completed, product developers might discover:

  • Problems with the usability of the design (e.g. poor button placement or an ill-sized handhold).
  • Safety concerns resulting from too-sharp edges and corners. 
  • Structural issues, such as weight imbalances or unforeseen use cases cause the product to tip over.
  • Handles and grip points that don’t have a pleasing feel or that interact poorly with surgical gloves or other materials.

Correcting problems like these after manufacturing has begun typically means months-long delays and hundreds of thousands of dollars in loss. 

The antidote to this lies in careful product definition, thorough testing, and extensive user analysis. That’s another reason MPE Inc.’s unified commercialization platform is so valuable. By continuously monitoring and evaluating the program’s performance — and incorporating user feedback all along the way — we identify areas for improvement early and optimize the outcome for our clients.

Mistake #3: Confusing competitive pricing with product differentiation. 

Some companies take a minimum viability approach to product development and look for every opportunity to undercut competitors on price. And to be sure, launching a competitively priced product is one way to turn a profit. 

But if you drive down costs at the expense of quality and usability, you’ll only undermine your users’ trust. And that, in turn, will hinder your chances of achieving long-lasting market adoption.

That’s why cost should not be your only means of differentiating your product. Rather, you should look for ways to add true value — the kind your users don’t mind paying more for. This starts by asking questions like:

  • What are our users’ pain points and how can we solve them? In other words, how can we make our users’ difficult jobs easier?
  • Do we understand how our product will fit into existing clinical workflows?
  • How hard is it to learn how to use this product? Are there ways to simplify training and make this product easier to adopt?
  • How can we surprise and delight our users and make our product a joy to use?

Again, it all goes back to understanding your users’ needs — both active and latent. Skimping on VOC research should never be an option, so MPE Inc.’s unified commercialization platform makes defining user needs a core part of the differentiation process, which can increase the ROI of your capital medical equipment.

Consider user needs from design to manufacturing — and beyond.

Anticipating and meeting your users’ needs is fundamental to launching a successful MedTech product and achieving high levels of market adoption. 

And it’s not just about meeting your primary users’ needs when they actually use the product. It’s also about anticipating what users will need regarding manufacturing, packaging, shipping, storage, sanitation, and — ultimately — disposal. In other words, it’s vital to consider what your users need at every stage of your product’s lifecycle

MPE Inc. can help. 

Led by our control planes of differentiation, market adoption, and compliance — and with decades of experience in mid-volume device and equipment development under our belts — we can take on all or part of your project and lead you smoothly from ideation to launch. 

Ready to get started? Let’s talk.