Bringing an innovative new product to market is exciting.
You have had a moment of genius and devised a concept that could change the landscape of medical technology forever. It is ground-breaking, innovative and could revolutionise treatment, not only for the patient, but also for the clinician involved. You’re going to save the world! And let’s face it, when the medical world goes mad for your new device, you’re not going to be short of a bob or two either. So, let’s get it on the market quick! Right? Wrong… The idea is just the start.
So, what else do you have to consider?
Well, think of your new innovative product idea as the sail of a kite. You have the main part of your final concept in your hands and you’re keen to get it flying, but without a cross bar, a spine and a tail, it simply will not work; and without a line and spool you would have no control over it. Each of these very simple factors could easily be missed, but each is crucial to flying a kite. Omit just one of them and your chances of getting airborne are minimal. You will end up with something that is not fit for purpose. This is a good analogy for developing a medical device – the device itself is just part of the process. Which brings me nicely on to the first consideration…
I have written previously about the importance of following a process for the design and development of medical devices. It sounds laborious, unexciting and possibly at times unnecessary, but a clear process actually provides you with a definitive roadmap, which details your route to market in the most direct and efficient way. Many programmes fall foul as they attempt to fast track or skip certain seemingly ‘nice to have’ elements, with a realisation at the end of the project that they cannot be ‘retrofitted’ and were, in fact, necessary. It is worth noting that product design within the medical sector typically has a cycle of between two and five years, especially when ground-breaking tech is involved. But by outlining your programme from the start, with as much detail and pedanticism as possible, you will find yourself with a clear list of highlighted areas on which to focus. These areas might include finding (or developing) the right technology, raising finance, establishing the target market, working out the shape of the team that you will need to build, understanding the regulatory requirements and confirming the user needs.
The end user is key. Whilst your idea might be revolutionary and your team may be filled with very capable engineers and designers, they will not be immersed in the day-to-day experience of clinical use. The end user can report whether there is in fact a need (and therefore a market) for your design and, if so, can provide crucial input to the practical application of your product. Your team and their technical skills therefore need to be guided by the knowledge of users if you are to maximise the likelihood of success. User engagement should be done throughout the development process. Each user group will have a different set of requirements and bugbears when it comes to product use, so having a wide, consultative approach will ensure increased stakeholder buy-in and mitigate the likelihood of facing procurement obstacles further down the line.
Understanding your user and the market around them is the first main step of a development programme, but how do you translate that information into a product? The next step is translating what the users have told you into detailed specifications. If you look at product development like a colour-by-numbers pattern, the numbers represent your specifications. Without them, you might possibly end up with a product that resembles the intended item, but the finer details, what the user really needs, would be lacking. By creating detailed User and Product Requirement Specifications, your development team will know exactly what the end product needs to looks like and therefore how to formulate the development programme. If your end-user has specified a Mondrian, your engineers need to know exactly which square to paint red. Writing detailed specifications is not a walk in the park… so brush up by reading our recent article on the five things you wish you knew about User and Product Requirement Specifications – and don’t say we never give anything away!
Nobody likes the guy who constantly plays devil’s advocate – the one whose glass is always half empty. But sadly, in product design and development, that guy is one of your strongest assets. The expression “I’m sure it’ll be fine” is not your friend and has no place in your development programme. Instead, embrace your fine-toothed comb and focus on the areas of your programme which you may stumble at. I cannot stress enough how important it is to identify as many red flags as early as possible. Once you know what might go wrong, you can come up with a plan to address the issues. Planning for risks is as important as mitigating them; without one, you can’t really have the other!
A structured approach is key. By identifying, assessing and scoring risks, you can create a plan to minimise their impact. Avoid aiming for perfection, as you may be blind to things that could go wrong; instead focus on what really matters, build your project up in layers and scrutinise every aspect of your programme, letting the process guide you through each step properly.
To sum it all up…
Overall, the focus throughout your project should be evaluation. You should be constantly testing (the market, the product, the need), evaluating, verifying, validating and optimising if required. It may be a great product, but is the market ready for it? Are you providing users with the product they need? Are you providing users with a product they can easily use? How is your product unique? Will your product be a catalyst for change?
We understand more than most how exciting it is to have the seedling of a ground-breaking product in your hand; but don’t get ahead of yourself, these things take time. Ensure that the ground is prepared, the correct team is in place and you have all of the tools, information and components required to nurture your sapling. Then, with careful nourishment and the right environment, in two to five years your tree should be bearing fruit. And of course, we are always here to help… just call us green fingered.
For more information on getting your product to market or to chat with one of our team about your product design and development requirements, please contact us:
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