Failure is expensive.  Very expensive.

Particularly when you’re developing a medical device.

There are 5 things you should know about, to avoid the painful bite of failure; 7 steps you’ll want to take.

At the heart of every successful project are 5 key things:

  • “Begin with the end in mind”. That’s all about understanding where you’re going to, listening to the ultimate customer’s needs (which are probably not the things they say they “need”). It’s then about having a route to get from here to there, a clear path through the detail of how you’re meeting those requirements
  • A cycle of planning, doing, checking how the “doing” went, acting on the results of the check
  • Risk based thinking and action (not doing too much, not doing too little, doing just the right amount, of the right things) – instead of just rolling the dice
  • Making decisions based upon evidence.  Evidence that you have the confidence to rely upon
  • Measuring what you’ve done, analysing the results and making frequent small course corrections

It’s fair to say that, miss out on one of these, and you’re massively increasing the chances of failure. And you’ll be juggling all this while time passes; the patent clock, the market advantage clock, diminishing returns on investment, the project “bank account” balance.

Perhaps you’re thinking that you need to make best use of the time you have, with all these ticking clocks.

Maybe it’s time to take a fresh look at what you’re doing, to make best use of the time and funding you have available. It’s time to see how you measure up against the 5 key things – things that you know will mean the difference between success and failure.

Check what you’re doing against a recognised benchmark

Take a look, warts and all, at how mature your development methods and their results are, comparing them to a recognised benchmark.   You could save time deciding what to compare your work to; that’s what standards are for. Of course, it needs to be the right standard, so for healthcare, we’re really talking about ISO 13485:2016 and ISO 14971:2012 as a minimum.

The approach will look like this;

  1. Identify which parts of your selected standard(s) should be included, which parts of the standard(s) are excluded (for example, you may not install, service or decommission medical devices, so including those clauses of a standard wouldn’t make sense)
  2. Make an honest, frank appraisal of how well your activities and documents match up to your business needs, as each clause of the standard you’ve chosen as the benchmark
  3. Note down observations
    • Things that aren’t quite up to scratch but won’t kill you straight away
    • Clear gaps that you’ll need to address – things that will either kill you or are serious
    • Things that are really working well for your people, your clients and your business
  4. Plan how you’ll address the observations that need fixing
  5. Work on the activities you’ve planned, checking back often to make sure you’re still on the right track
  6. When you’ve finished, check back again, to set your mind at ease that what you’ve achieved really fits the bill
  7. After a reasonable time, check back once more, to confirm that nothing has drifted with time


Whoever you get to look over what you’re doing should have the knowledge, capability and experience to give you a complete picture, along with pragmatic ways to address the gaps. Make sure they’re really independent of the project or process.

You won’t be surprised to read that this is something we regularly help our clients with. They tell us they’re reassured by the detailed and comprehensive reporting and planning we deliver to them;

– some choose to go on and follow the plan themselves,

– others feel more comfortable having us walking alongside them,

– some even prefer for us to take care of everything for them, so they can get on with the things they’re best at.

Right about now, you may be thinking “why should I believe you?”

Good question.

The short answer is that we put our money where our mouth is.

The slightly longer answer is that we did just this, for our company.

Achieving our plan to fix the gaps meant distilling all our experiences of what works well and what doesn’t, into a development approach.

Naturally, we put it all on paper, in a Quality Management System that works for us. Benefiting from our experiences of what really needs to be part of a quality system and what doesn’t. Benefiting from our knowledge of the most pragmatic ways to achieve compliance, without breaking the bank and without things that are just simply excessive.

The independent view…

We had independent eyes look at what we planned on doing, and again along the way. We’re proud to say that the fruits of our labours have been independently reviewed and certified as compliant with ISO 13485:2016, the very latest version of the Medical Device Quality Standard.

So, you can be sure that we really do understand the reasons for failure, and can help you avoid or mitigate them as far as possible – after all, it’s all about spotting risks and minimising their impact on your business.

Tick, tock

The patent clock…

the market advantage clock…

the ROI clock…

…they’re all ticking.


Take the first step, today, to make sure you best use the time you have left, before they wind down.

Follow the 7 steps we’ve outlined, to minimise the risk of failure.