Well, to cut a long story short...there is no set route. However, the eg technology team have put together this quick guide, which pulls out some key tips for start-ups and hopefully makes the development pathway a little more navigable.
1. Set the right expectations
The standard development cycle for a new product within the MedTech sector is not short…it can in fact take years, especially when ground-breaking technological advances are involved. Many start-ups have an incredible design, concept or idea that they believe will have a significant impact on the medical landscape. They are therefore eager to get their development underway and get their potentially life-saving innovation onto the market! However, this hasty approach is not only fraught with risk but can be somewhat unrealistic. I have mentioned previously the importance of following a strict process when designing and developing medical devices. It may at times feel like the wind is being taken out of your sails, but it is important not to mistake end-to-end programme planning and risk analysis with antagonism or even programme sabotage! Product development is often a complex journey and things take longer and cost more than anticipated, so a clear process will provide you with a definitive roadmap, which details your route to market in the most direct and efficient way. Each programme should therefore have a clear outline from the very start. Detail is key and a clear list of focal areas for your project will stand you in good stead. Your list may 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.
2. Understand the competitive landscape and clearly define your USP
Differentiation is a key ingredient in the recipe for success in product design and development. There are numerous innovations brought to light daily and without full visibility of your competitive landscape, you can spend precious time and money developing a solution to a problem, which may already have been solved. Imagine spending time and money developing a medical device, only to find out that the technology in which you have invested is already protected by a third party. The MedTech product design and development field is crowded and freedom-to-operate, patents, designs and trademarks should be key considerations within your process, helping to drive the development forward. As with risk analysis, the sooner problematic patents and pre-registered designs are identified, the sooner these can be factored into your programme. This market insight should also be reviewed regularly to maintain sufficient ongoing protection for your own design. When surveyed by CB Insights, 20% of the 111 start-ups attributed their failure to being ‘outcompeted’; a figure which highlights the importance of competitive analysis.
3. Understand your user and keep them central to your design
On the flip side, creating a truly unique product when there is no actual requirement for it, is also an easy mistake to make and is often the downfall of many start-ups. In fact, 35% of start-ups fail as there is no (or insufficient) market need for their product. It is incredibly easy to get caught up in the process of product design but is there really a problem that needs to be solved? Is the timing right? Are there already established alternatives on the market? For your product to be successful, it needs to solve a common problem but be unique in its solution. This messaging also needs to be front and centre when marketing the product; what does your product solve? What is your differentiator? And why should consumers choose your solution over any other?
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? Usability is an integral part of product development; it is about gaining a deep understanding of how the product is used and the context in which the user interacts with the product across its life cycle. But is often retrofitted or even omitted completely. This can cause enormous problems and can often lead to the issue above, where a product is created which is unsuitable and not fit for purpose. Gaining full insight on the users, user tasks, the user interface, use scenarios and use environment early on in your development is key to creating a successful product.
The next step is translating what the users have told you into detailed specifications.
4. Challenge assumptions and continuously test!
User studies allow you to manage expectations and challenge assumptions within your development. It is often surprising how even the most confident assumptions can be incorrect and integrating user insight into your design throughout, can enable you to better mitigate risks, right from the start of your programme. By considering all potential use scenarios, you can then factor them into your development and design out any potential errors, early. This process should be referenced in all supporting documentation, detailing your iterative design, and illustrating how you have mitigated and controlled risks to an acceptable level before clinical studies. By continuously testing and incorporating feedback into your process, you create a closed-loop development, which will result in a far better product, that addresses your users’ pain points.
5. Look for funding through established sources
As mentioned above, it is always wise to raise more funding than you need. Although you can plan for most things, there is always room for the unexpected to occur when developing a product. Especially from a financial viewpoint! Market needs may change, specified technology may not be suitable or new technology may suddenly become available or material prices may change. At eg, we often employ a phased schedule of work to programmes,enable clients to manage the financial aspects of the development better. Prototypes may also be needed to maintain or secure investment, so a phased approach allows an iterative design process that aligns with our client’s financial planning. Initial financial support often comes from family or friends; however, it is important that start-ups don’t think they have to fund their project independently if they don’t have this backing. Looking for funding sources through accelerators, grant funding and angel investors will often yield success. Have a look at some of eg’s key partners, such as EIT Health, MedTech SuperConnector and Medilink to see their funding initiatives.
6. Don’t be afraid to get professional help!
Bringing a new product or service to market is a multi-disciplinary challenge. Not only do you have to be concerned with the design and manufacture of your product, but you also need to consider any intellectual property and patent issues, as well as the user and incorporating their requirements. You might need to find a manufacturer, think about how you are going to package and ship your product, deal with returns, servicing and support. In many global markets, you will also have to think about how your product is regulated; whether that's meeting basic requirements for safety or meeting more specific standards, within a regulated industry such as medical.
This is a lot to think about for a start-up when your primary focus is refining the solution to your problem. However, you can always look outside of your business if you want to progress faster and streamline your route to market. A specialist ISO 13485 accredited, product engineering design and development consultancy is already geared up to turn innovation into real, marketable products. They have experienced engineers across disciplines with the expertise to drive your development forward using their own refined processes, knowledge of the development pathway and regulatory experts who will save you the cost and complexity of sourcing, integrating and operating a ’best of breed’ solution. You will be allocated a project manager who will ensure your development pathway is mapped out and that each key step, from risk management and user research to supplier evaluations and process failure mode & effects analysis, is integrated and optimised. Product development needs to be collaborative and development expertise is a skill to be leveraged!
For more information on getting your technology or ideas to market, or to chat with one of the eg team about your product design and development requirements, please get in touch: