The four secrets to succesful medical devices

The four secrets to successful medical devices

We often see medical devices that fail to launch at the expected date, fail to reach sales goals and thereby ROI, or even fail to reach market launch all together. When diving into the reasons for this, data reveals that project scope, execution, and expectations are key factors. Also, new studies confirm our belief:


Most firms fail to recognize and implement user insights at an early stage, resulting in unmet user needs and failed market penetration.


According to the 2015 KPMG CEO Outlook, one of CEOs’ most explicit concerns is maintaining the company’s position on market (69%) and keeping products relevant three years from now (66%). In our opinion, the most effective way to secure your market position and develop long-lasting relevant products is to focus on the development of the right solution and maximizing value creation for users, from day one. You do this, by embracing these four guidelines to successful medical devices:



We often see “innovation” initiatives that have completely skipped the discovery, learning and thinking activities. They move directly to idea generation. When you hear people say, “Brainstorming doesn’t work”, they are correct if and when businesses skip the preceding steps. How can you generate interesting ideas or solutions when you have not yet discovered new opportunities or needs?nIf you want to innovate, to create truly new ideas, you need to be willing to discover new needs, new markets or new opportunities. Once you have discovered those opportunities, you need to learn more about the emerging market or need. Why does it exist? Why is it unsatisfied with existing solutions? Once your discovery and learning are complete, you can then begin to interpret, analyse and understand what the true needs and wishes are. Only then are you ready to generate ideas, which will really be solutions.



More often than not, project knowledge is lost during development. Having human factors specialists as an integrated part of the development team is the best way to ensure that user needs are in focus throughout the development process and that these are met when the medical device is ultimately launched. If this is not possible, it is crucial that you sum up user needs and insights in some kind of engaging format that everybody in the project team can use and see. Getting a designer to work on this material – a poster, a video or an interactive application – can help you ensure that the material is both understandable and attractive. The danger is however, that this will end up in a drawer somewhere. To prevent this, display it in the hallway or in the project room and use it at project meetings. Having it in a “public” place has the added benefit of indulging the interest from passer-by, increasing focus on both your project and your forward thinking approach.



Most project managers believe that a high level of innovation and a high level of feasibility with respect to engineering and production are contradictory factors, and that compromises have to be made on both sides in order for the medical device to be a success. This is not true. If you include members of your production team, your engineering team and your regulatory team in the early stages of the development of your device, you highly increase the success rate of the entire project. For this to succeed, it is key that you have the right team-members who can turn off their native critical sense during the creative phases and turn it back on during the phases of condensation. This might take some practise and the learning curve within the organization can be steep. The added benefit is, however, that this will save you valuable time in the phase of detailed engineering, as most concerns have already been eliminated. Remember that…


Going 100 mph in the wrong direction will get you farnoff course – going 90 mph in the right direction will not.


Having set up milestones, frequent status meetings and immoveable deadlines gets you to your next destination (the harbour, to stick to the maritime lingo) the fastest. In addition, and contradictory to common beliefs, these constraints aid creativity. There is a strong scientific basis as to why working within constraints, even in the creative phases, is more efficient than starting with a blank sheet of paper. Having a starting point for your thoughts spark connections in parallel throughout several parts of your brain, which then branch out into other new connections. A complete lack of constraints forces your brain to search all of it’s connections, resulting in an un-focused and somewhat frustrated mind set. In the words of the Grammy Award winner Jack White (White Stripes):


“Deadlines and things make you creative. But opportunity and telling yourself ‘oh you have all the time in the world, all the money in the world, all the colours in the palette you want, anything you want’; that just kills creativity”
– Jack White

See the full interview of Jack White on restrictions and creativity here.


Yes and no. Obviously, you need to work with many other important issues such as regulatory affairs, clinical tests, production setup, etc. If you have got these aspects handled, our record of accomplishment shows that following the above guidelines drastically increases the chances of developing successful medical devices and obtaining on time product launches. Additionally, your organisation will expand and evolve because this user centred approach teaches your employees and colleagues the best practises within your field of expertise.

For us, developing the right solution and maximizing value creation is not enough. In order to succeed fully, you need to build organizational knowledge at the same time.

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