The elephant in the room: addressing device development challenges early on

16 Jun 2022 4min read

I’ve often heard colleagues say that it would be the ‘challenge we didn’t anticipate, that catches us out’. I have certainly experienced this. But more often than not, the challenges or ‘project killers’ I have witnessed were identified early in the medical device programme. In this blog I discuss the reasons why unanswered questions asked at the start of a project can get carried through development phases. This blog also talks about how a lean approach to problem-solving together with an early assessment of device feasibility, can stop an unanswered question becoming an elephant in the room.

It can be tempting to avoid having difficult conversations about potential challenges in the early stages of a medical device project. Coming up with ideas can be difficult enough without people playing the role of the devil’s advocate. But failing to question ideas early can lead to significant wasted time and false hopes, resulting in a product solution that may be inviable. At Team Consulting, we take several actions during the early phases of a project to reduce these risks. Based on my experience, here are 3 top tips:

Talk to people outside the core project team

Those with a viewpoint from outside the details and politics of a project are often in the best position to spot the next significant obstacle. Kick-off meetings and informal conversations with colleagues beyond the core project team can be a valuable opportunity to get feedback on ideas and challenge assumptions. Some examples of probing questions which should be asked early in the development of a product are:

  • How will you make the device cheap enough?
  • What benefit does the device offer the user compared to its closest competitor?
  • How will you design the product in a way that removes potential user error?

These questions may be frustrating at the start of a project when little detail has been defined. But tackling these challenges early on can significantly reduce development time when creating a market-leading product.

Discussing a project

Test your assumptions

In Tim Brown’s Design Thinking manifesto for organisations, ‘Change by Design’, IDEO’s co-CEO writes about the value of giving form to ideas quickly through prototyping. It is clear that Tim attributes much of IDEO’s success to their proficiency in the art of making ideas tangible and even argues that the “time to first prototype” could be used as a metric for how innovative the team is. My favourite quote from the book provides a good lesson on the fidelity required to render a prototype useful:

“A successful prototype is not one that works flawlessly, it is the one that teaches us something about our objectives, our process and about ourselves”.

I see this as encouragement that prototypes do not need to be used to prove that an idea will work. They should be used to teach us something about a concept and help us resolve the ‘big unanswered’ questions that come up in the early stages of the project. Hesitancy to ‘think with our hands’ and build ‘ugly’ models increase the risk that these questions become cumbersome payloads that get carried through the product development phases.

If your concerns relate to potential user behaviour, get a prototype made and put it into the users’ hands as soon as you can. If it’s about technical performance, design a suitable test method to generate data that will improve your understanding. Let the test results and user feedback answer your questions and feed the learnings into your next iteration. Go through this loop as many times as required to get the confidence you need to progress to the next phase of the project.


Avoid ‘ta-da’ moments

Thinking outside the box is sometimes exactly how we help our clients here at Team Consulting. However, the risk-reward must be carefully balanced. An idea, demonstrated through quality renders and high-resolution models, will be met with disappointment if a significant pitfall has been overlooked. It is safer to share these ideas early on and in their simplest form to get buy-in from the key stakeholders, rather than blowing the budget or heading down a path that no one else has faith in.

At Team Consulting, our willingness to challenge ourselves and (our colleagues!) address difficult questions early in your project help us develop award winning medical devices for our clients.

Get in touch to find out how we can help you.

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