The long game: how strategic thinking prevents medical device development failure

Medical devices are among the hardest products to develop. They’re highly complex and yet need to be unbelievably reliable and intuitive to use. This makes their development particularly demanding.

At the same time, in many organisations, multi-functional teams often work in silos. This often leads to missed opportunities to generate the best possible evidence and make informed decisions, which can ultimately determine whether a development project succeeds or falters. It’s all too easy for the project leaders to slip into the trap of focusing on apparent progress rather than addressing underlying risks.

With more than 35 years of medical device development experience, we’ve developed strategies to keep everyone focused on the right outcomes at every stage. By adopting a mindset that values strategic thinking over immediate gains, teams can avoid costly setbacks and achieve better outcomes in the long run.

In this brief guide, we’ll explore the common pitfalls along with tips to avoid them.

Medical device development projects often go wrong when you…

Integrated, form-factor prototypes look more finished than prototypes of the individual modules. But if there are major unaddressed risks or you’re not clear on how (or if) the modules which make up the device will work, you’re probably going to have to make major changes. That’ll always be slower and costlier with an integrated device prototype. Or, worse, when uncertain design requirements – perhaps inputs from regulatory? – finally become clear, the design often doesn’t meet them – and you have to work around the constraints of your own design to fix it.

TIP: Focus on wearing down the risk list and defining and proving out the design first – then your form-factor design will be an asset, not a liability.

Everyone who works for a company has a commercial objective – they just use different skills to help deliver that commercial outcome. When scientists or engineers lose sight of that, you have a risk: they will seek to deliver a technical outcome, whether it’s the best route to the commercial outcome or not. For example, when is an experimental method or result “good enough”? Statistics and R&R methodology can provide guidance, but the fundamental answer is “when it enables the purpose for which it is being done” – and, at bottom, that’ll be commercial. Stopping a task before it supports the objective is a risk; stopping afterwards leads to avoidable delays.

TIP: Organise development projects so that everyone can see and must describe their work in terms visibly derived from the commercial needs and contributing to the commercial outcomes.

Companies develop products to acquire new competitive advantage – but it’s easy to slip from that into the idea that innovation is itself the target. Innovation means doing something new or in a new way, and that’s almost always riskier and less predictable – development, manufacturing, regulatory – than the tried-and-tested way.

TIP: Innovation is risk: take it carefully, and only when it’s worth it. Recognise your own tendency to be drawn in by interesting things…

We’re almost hardwired to ignore Thomas Edison’s insight that “genius is one percent inspiration and ninety-nine percent perspiration”. Perhaps it’s just too tempting to hope that one clever idea will make it all easy. Clever ideas (and, for that matter, market or medical insight) are really important, but patient and rigorous – and usually unspectacular – execution is always necessary to achieve a successful medical device. And, after all, do we really know that an idea was good before its implications become apparent in the later stages of development?

TIP: Celebrate and invest in the people who put in the hard yards – even when it’s tedious and laborious – and make sure to involve the ideators in the outworkings of their big ideas.

Medical device development projects often go wrong when you…

The “best-case plan” is what you get if you know the results of every activity beforehand and assume that they’ll be favourable. If you’re doing something for the first time, this will not happen. Pretending that it might will actually slow you down: if you recognise that something is risky, you need to explore multiple options, aim to learn, and make your mistakes early and cheap. By contrast, expecting the best case implies unwarranted assumptions and creates unachievable time pressure from the start. This, in turn, leads to riskier behaviour, and inevitably the substantial overhead of managing a “delayed project” – e.g. planning for a journey of five miles across the city to take 10 minutes is not wise. All the evidence points the same way: infeasible timelines delay projects.

TIP: Create a realistic baseline based on historic data from real projects, and assume that early on you will focus on wearing down risks.

Thinking a design is production-mature when it really isn’t has several consequences. First, you won’t develop it further at the point when you really should. If you’re lucky, you’ll just have to do the work at a later and less convenient time; more likely, you’ll find out that your design or process doesn’t have the capabilities you thought it did, and which you are now tied into needing. Second, this plays into thinking “we’re nearly finished” when you aren’t, bringing with it a reluctance to make desirable design or process changes, and carrying unnecessary risk through the rest of the development.

TIP: Follow the guidance of subject matter experts – especially those involved in production – in assessing maturity.

Correlation is not causation. Just because a process or approach has been around for a while doesn’t mean it has been tested or is fully matured. Familiar ideas can circulate in projects, organisations, or markets for years, without ever being rigorously tested. When these untested assumptions slip into development, they can cause havoc if their age is mistaken for proven reliability.

TIP: Never allow any design or process into a development project without a thorough review of the evidence for its capability. If the evidence is there, this will be quick and easy; if it’s not… well, now you know.

Most R&D experts keep a risk register of some kind and have a process for looking into the highest-ranking items on it. But it’s common for these to be low-level, add-on activities rather than being given the same importance as – and being an unavoidable part of – defining and developing the design. Taking risks seriously has significant short-term cost, in both time and money – but letting the risk rumble is more costly still: the best time to get bad news is always now.

TIP: Make sure that you plan mitigation activities for all risks that could set you back a lot if they come to pass during the earliest stages of development to establish as firmly as possible whether they will bite, and how your device design could avoid them. Where it seems like a risk cannot be evaluated, get creative – most risks (including manufacturing risks) can be evaluated, and it’s usually worth the cost.

Medical device development projects often go wrong when you…

The only thing you can deliver at negligible risk is a parcel – and even then, FedEx would probably beg to differ! A new product is always a somewhat risky thing to develop – just because it’s new – but the specifics of the requirements modulate that risk massively. Those who understand commercial risks and benefits and those who understand the delivery risks and do the design are usually not the same people: typically they have different backgrounds and speak different “languages”, and may even be on different sites in different countries – which makes achieving a good balance of benefits and risks very difficult. But, difficult or not, getting this wrong can add years to development for a benefit that would have been dropped in a heartbeat if its implications had been clear at the start.

TIP: Establish dialogue between contributors, with each group providing their expertise so that the eventual requirements provide a balance.

We are hard-wired to discount bigger pain in the future compared to modest pain right now. Unfortunately, fixing problems inevitably gets slower, costlier, and more difficult as projects progress, so avoiding a bit of disruption and planning delay today leads to major trouble down the line – in a big project, it’s practically guaranteed.

TIP: Get an external view – regular and detailed review by someone who has no “skin in the game”, and every incentive to play for strategic success – and follow that advice, even when it hurts.

Decisions are easy when all of the evidence is clear and points in the same direction. Most of the time, they aren’t. When many of the considerations are outside the decision-maker’s expertise, it is doubly hard. In these circumstances, it can be tempting to object that the experts are complicating things needlessly. Equally, a hurried expert will often fall back on presenting raw results or details as if their decades of experience in interpreting such things were shared by the whole team. The result is expert insight hidden within inaccessible detail – and the strong temptation for the decision-maker to dismiss the lot in the interests of a quick decision.

TIP: Standard reporting templates which focus attention on the implications of insight can help – but the most important factor is a culture of assuming that other people’s expertise is as important to success as your own, giving you the mental discipline to explain yourself clearly and exert yourself to understand your colleagues.

Medical device development projects often go wrong when you… 

Discovering that a fastener is too weak early in the development is a minor issue – easily fixed with a quick test and a CAD adjustment. However, if that weakness is only uncovered after product deployment, it becomes a major, costly failure. If team members view an unsuccessful test as failure rather than an opportunity to learn, the likelihood of catastrophic failure increases. Finding out when something works implies finding out when it doesn’t; selecting the best option requires looking for and finding limitations. Effective development hinges on understanding both what works and what doesn’t. De-risking – and that is, after all, the name of the game – depends on knowing what doesn’t work and when.

TIP: It’s helpful to get the team thinking about strategic over tactical “success”, for example, by framing goals for activities well: “determine whether module A performs within requirements over the full range of parameters B and C” rather than “prove that…”. But a big factor is the team having no fear of failing small – only then can you reduce the chances of failing big.

TTP’s HealthTech team partners with organisations around the world to help design and deliver advanced medical devices and drug delivery systems that improve both patient and commercial outcomes. Get in touch with one of our team to find out how we can help you.