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Engineers working on a new medical device must continuously ask themselves if their product is addressing an unmet need or if they are developing a unicorn - ideas that are nice to look at, but will never make it off the drawing board. At this year’s Medtec UK, we talked to James Davies, senior consultant, and Uri Baruch, head of medical devices at Cambridge Design Partnership, about common mistakes in development projects and how to kill a unicorn.

What are the most common reasons a project fails on the way from idea to market-ready product?

A realisation - too late - that the product is not addressing an unmet need. Early testing of an idea or a concept with end users and other stakeholders helps to kill bad ideas quickly ensuring that resources are not spent on developing them and instead the resources can be diverted to those which have the best chance of market success. If market engagement is undertaken BEFORE generating ideas, then the risk of developing bad ideas in the first place is greatly reduced and the result is few projects which fail during the development process.

How do you find out if your idea is a unicorn? How can you assess if there is an actual demand for the product you are developing?

As above. We can’t stress how important it is to keep testing your ideas, concepts, prototypes... firstly against the requirements that have been drawn up (an internal process) and then again with customers or end users; be they patients, healthcare practitioners or care-givers.

Ideally you should know if there is a demand for a product before the development process starts. If a product concept has materialised from an ideas-, science-, or technology-first approach, then the very next step should be to see if there is demand.

Does it better meet a clinical need? Talk to or observe users. What job will your product enable people to do? Will it enable them to do it more satisfactorily than they are able to now? Does it better meet functional needs? Does it better meet emotional and sensorial needs? Does it meet needs at a lower cost? If the answer to all of these is no, then there is unlikely to be demand for your product.

Ideas for medical devices are often developed by engineers who have little experience with market research or the capacities to do that. Is there an advice you can give them, is there a cheap way to do some basic market research, e.g. to assess the market size, main competitors etc?

We wouldn’t really advocate compromising on the market research step. Just like technical development, it has the ability to define whether or not an idea will ultimately be successful. It is likely that if an organisation has little experience in a vital technical discipline, they will look outside their own organisation to find it. The same path can be followed for market research and research for innovation. There are companies who can offer this support.

Many medical device companies fall into the trap of using only Key Opinion Leaders or expert users as their source of market research as it’s seen as a low-cost option. Whilst this route can provide some great input, companies can miss out on vital insight that can contribute to the development of a product for a wider user base. In fact, designing for less-experiencing users can be a key differentiator and one which can open the door for a disruptive innovation.

Market size and the competitive landscape is only a part of the story that must be understood. Whilst these can, largely, be obtained through desk research – once you have defined correctly the market that is relevant to your new idea – the potential success of your idea can only be assessed by understanding how your product will be valued by the market. What will differentiate it? What will it enable people to do that they can’t do with competitor products? How will it ‘delight’ the users and wider stakeholders?

How can start-ups make sure that they are developing a product that payers are willing to pay for? At which point of the development should they approach payers? Are payers usually willing to engage in such a discussion at an early stage?

Engage right at the outset of the project, make sure your idea is sound and that the direction you are taking benefits the payer (even if they cannot see it). Then test the idea with them at regular intervals to ensure a good fit.

Payers will be happy to engage if they see a benefit early on as they get more say and input into the product.

You said that timing is everything in product development, Can you give an example what can happen, when a technology is too early or too late on the market? How do I make sure that the time is ripe?

Too fast – market/technology is not ready or there is no market ready to sell to. But if you’re too slow – you might get beaten to it – and an IP strategy is important here to protect your ideas.

Even if potentially the market is ready, if the technology is too early the infrastructure may not be there to support it. This way even if the technology is sound the support system allowing it to flourish is not. See the original apple TV, or smart phones before apps.

The way to make sure time is ripe is to know the dependencies between the need and consumer - this understanding can inform the timelines and define what needs to happen in order for the solution to be successful.

A key element to timing is having the right resources at the right time - you don’t want an under-utilised team of people whilst waiting for external events (clinical, regulatory, tooling etc.). One strategy is a flexible team, to switch on and switch off at key points during the development process. Move your team resource around and be lean:

  • Fast initial development to get to clinical testing

  • Redeploy development teams to other projects off whilst waiting for field data (clinical trials)

  • Quick engagement of team to integrate clinical data input

  • Team redeployed again whilst waiting for regulatory testing.

Read the article on the EMDT website

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