After the Designs are Done: Why Your Medical Device Needs an Agency’s Support Phase

 In Engineering, Medical Product Design

If you’re considering partnering with an agency to help you realize your vision for a new medical device, you already know you need outside expertise for the design phase of your project. But what happens after everyone signs off on a final version of the completed designs? Whether your product is digital, hardware, or a combination of the two, the reality is that even the most well-conceived designs may need to be revisited during development. What level of support will you receive if you encounter unexpected problems during that time?

The answer to that question depends on the agency with which you partner. At MPE (Formerly Mindflow Design) , we recognize that many of our clients want and need to have continued access to our team even after our design work is complete. That’s why we offer a support phase to accommodate unexpected issues and changes as clients take our designs and through detailed development.

Medical Device Development with a Design Agency: The Need for a Support Phase

Once a medical device project goes into development, companies often find that further design tweaks are needed. Generally speaking, development-stage design changes arise for two reasons:

  • Unforeseen technical issues. These issues may stem from any number of factors. For example, it might be that your software engineers realize they need to use a different solution or integration than anticipated. These new solutions  necessitate new workflows. Or, in the case of a hardware device, it could be that a specific part or material needs to be swapped out due to the results of qualification testing, pricing, or durability. You couldn’t have anticipated these challenges in the design phase, so they inevitably result in design alterations.

  • Newly illuminated user, technical, or business needs. For example, you might learn over the course of further user testing that a particular interface needs to be adjusted. If your team identifies new user or business needs after designs have been finalized, the designs will almost certainly need to be adjusted to accommodate that new information. Depending on what you discover, new user, technical and business needs may necessitate simple design alterations or new solutions altogether.

If you reach this point and don’t have ready access to the agency that produced your designs, you have two options. The first is to attempt to make the changes in-house or to engage a different design team to rework the designs. The risk here is that you lose continuity, context, and expertise as a new designer attempts to make sense of another designer’s work. Your second option is to re-engage your design agency. They can rework the designs efficiently — assuming you can get back on their schedule. To do this, you’ll need to reach back out to your design agency, negotiate a new contract, and wait to be slotted into their production schedule.

The best solution is to engage your design team in a support phase. Doing so gives you immediate access to your design agency as issues arise. Because of that, it safeguards against larger problems. Think of it as an insurance policy against your design investment.

The other benefit of signing up for a design support phase is that it gives your team an extra measure of flexibility in the medical device development process. It allows you to evolve the design as necessary — even after the main design phase is done. This is in keeping with MVP and agile product development approaches. When you reserve the ability to swiftly and efficiently make appropriate changes in manufacturing, you are more likely to end up with the best, most refined product offering.

Any company working on any type of medical device with a design agency can benefit from a support phase after the designs are finalized. In general, the support phase gives you on-demand access to your agency design team as you move through detailed development.

Design Support Phase: Software vs. Hardware Medical Devices

One thing to note: the design support phase will look somewhat different depending on whether your device is software, hardware, or some combination of the two.

The reason is that software development is much more fluid than building a physical product. Developers can adjust the code and immediately see those changes rendered in a prototype. It’s more of an instant feedback loop, which makes it inherently more flexible. Even after a digital product is released, it can be amended or updated by pushing out a new release. For these reasons, the cost of making changes to a software product is generally lower, even as you get closer to the product’s release. As a result, agile product development methodologies make sense for software devices. This approach allows product teams to rapidly iterate on their designs, even after a product is launched. In that sense, a digital product is never truly “finished.”

Hardware devices are completely different. The cost of making design changes rises significantly as you work toward higher and higher fidelity prototypes. Each round of designs and validation should move you closer to the final product in a more concrete way. You must make design decisions methodically using research findings and verification test results. The further into the process you go, the more costly and difficult it is to reverse those decisions.

When you transfer your finalized hardware medical device designs to manufacturing, the manufacturing company translates your design specs into tooling for production molds. This represents a major cost. In other words, the decision to make changes beyond this point shouldn’t be taken lightly. Even still, retaining your design agency on a support phase into the development stage makes sense. When you keep your design agency on retainer, you give yourself the ability to identify and correct issues as early as possible. And that translates to saved time and money.

If you’re planning to produce a new medical device, signing up for a design support phase with your design agency is a sound investment. It safeguards your product against major unforeseen issues and gives you the ability to respond swiftly and flexibly as problems arise.

The result? A better product that goes to market faster.


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