Developing a new medical device is a long and complex process. Tightening of regulatory requirements globally mean this already expensive process is becoming even more costly. Badly run development projects can overrun on cost and time and may ultimately have to be aborted with huge financial and opportunity cost. For small businesses and start-ups this can threaten the future of the whole company.
Development methodologies such as Agile and MVP (minimum viable product) popular with tech start-ups don't necessarily work in the medical device area where regulation requires all the details and documents in place before a product can be released on the market or tested with users. I have lost count of the number of times potential clients have asked, "We've got a working product, can you just help us with the regulatory side?" In many cases the review of the regulatory requirements quickly identifies that a fundamental redesign is required and much of the development has to be redone.
So, before embarking on the development of a medical device, it is important to understand the process and the potential pitfalls. With such a complex process it is impossible for a single article to cover every aspect of medical device development but from our experience of hundreds of development projects we have identified the areas where companies frequently have problems and created six points which can help to avoid these problems. We hope you find them useful.
1: Start with your PRS (Product Requirement Specification)
The Product Requirement Specification (PRS) defines everything about your product. It is probably the most important document for your whole development as is involved from the beginning to the end of the development. It's obviously very important from a regulatory point of view but it is also vital from a commercial and practical point of view. In a poll of medical device professionals carried out by IDC, changes to the product specification was the top cause of project delays (jointly with problems with the team), so getting this right, getting it agreed across the business, and sticking to it, are all critical to enabling the rapid development of a successful new medical device.
A typical detailed PRS is likely to include the following elements:
To create a complete and comprehensive product requirements specification requires significant time and effort. Much of the detailed information required is not going to be fully known at the outset so, when completing the first versions of the PRS, it is important that requirements or details that aren't known are marked as not known or provisional, rather than a guess, an inaccurate requirement or a requirement omitted. The PRS, therefore, is a document that continues to evolve and develop as the product development programme progresses so this creates a dilemma: If getting a clear PRS is so important, how can a business feel confident to start a project before all the requirements are known? The answer is to get enough clarity to allow the key decision to start the programme. The purpose of the PRS in the early stages is to create a clear target of what the project should achieve and therefore the focus should be on defining the key commercial and technical requirements such that the initial PRS should give everybody a clear vision of what the medical device to be developed will achieve. At a high level this should be able to be summarised into one or two sentences.
At IDC we use the following method to check that there is a clear vision and purpose to the development:
• "If we make a device that these users can use to perform this function with this benefit / performance level, that can be sold profitably at this price, and can be available in this market by this time then we know we can sell this many units"
An example of this would be the recent IDC development of the ShailyPen Protean injection pen.
During the course of the development, the PRS has become a very comprehensive document detailing all the requirements for the product but at the beginning the requirement was expressed as below.
"If we make an injection pen that patients with type 2 diabetes can use to daily self-inject diabetes drugs with the equivalent performance of the existing market leader and avoids infringing competitor patents, that can be sold profitably at X% below the price of the existing market leader and can be available in the US market by 2022 then we know we can sell between 1 and 5 million units per year."
This gave all the stakeholders and team members a clear vision of what the project would achieve and, in our experience, has proven to be a really effective way to identify any big unknowns that could pose a risk to the project.
2: Make a Detailed Plan
Making a plan for the project stages and activities is critical to estimating two of the most important elements for the commercial success of a device development project. These are:
• How long will it take?
• How much will it cost?
Knowing these is critical for assigning investment and making business plans around the development and once the project is live enables the project to be carried out efficiently. Making a realistic plan requires an understanding of all the activities that need to be carried out in order to bring a medical device to market. At IDC we have a four-stage development programme which acts as a top level framework for planning new developments. The four stages are Explore, Create, Define and Deliver.
Experience of similar developments can be used to give an overall range for the budget and timeline for the development of a particular device but, invariably, the device development projects we see tend to have their own set of challenges and require a specific project plan tailored to addressing the unique requirements of each development. A detailed list of tasks and a development timeline in the form of a Gantt chart is the standard format for the project plan.
So how do you go about creating an appropriate and realistic plan for your development? This brings us to point No 3.
3: Identify the High Risk Elements
Uncertainty equals risk, so in order to reduce the risk it is important to identify any areas of uncertainty and get answers as early as possible in the project. One way to do this is to ask the following questions:
"What things do we not yet know?" and
"What are we planning to do that is different from what is already commonly done?"
As an example, several years ago we were asked to design an ECG heart monitor for consumers. We started by looking at the clients’ vision for the project. Putting this in our top level vision statement gave us the following:
"If we make an ECG heart monitor that consumers aged 45+ can use to check their heart health with features to be defined, that can be sold profitably at price to be confirmed, and can be available in UK and Europe market within 18 months then we know we can sell ? units per year."
This raised a number of questions.
1. Are we certain that our target users want a device to do this job?
2. Would they prefer to go to a GP?
3. How much are they prepared to pay for such a device (if they want such a device at all)?
4. How easy is it to diagnose heart problems from an ECG?
5. Is the technology capable of doing this?
6. What is the market size?
So rather than start designing, the first phase of work was focused on answering these questions which naturally led into a research programme with target users and healthcare professionals for planning new developments.
The result was that the technology at the time couldn't reliably diagnose heart problems without a high risk of false alarms. The research identified that users didn't feel confident interpreting ECG data themselves and therefore anyone with a concern about their heart wanted the support of a professional rather than buying a device and managing it themselves. Consequently, we advised the client not to go ahead with the development. For the injection pen projects the biggest challenge was avoiding competitor IP so the first activities were patent searches and reviews. For the video laryngoscope, the key risk areas were a combination of user, technical and cost based: can we get a high quality video image of the intubation from a camera in the tip of the device to a large conveniently located screen on the device. Consequently, the first phases involved electronics research and making mock ups and prototypes to test with clinicians. Once these were approved, the full design and engineering development could begin.
4: Define the Ideal User Experience
Product development always involves compromise. In order to make the most successful product possible, we believe it is essential to define the 'Ideal User Experience'. We know that, because of commercial or technical limitations, the ideal user experience may not be achievable but by defining the ideal, we can understand the elements which negatively impact the user experience and ensure that we get the best possible user experience within the constraints of manufacturing processes, technology, cost and regulations. This applies throughout the development as decisions about necessary changes are always done keeping in mind what is best for the user. Taking this approach has long term benefits too. Technologies develop and become cheaper over time. Even hugely successful devices get replaced by newer, better versions. Keeping a picture of what the best possible product might look like allows you to identify the opportunities created by new technologies, materials or processes to rapidly create the next innovation in the market.
Mapping out the product and user journey for a surgical stapler.
5: Don't Squeeze Out the Time for Creativity
6: Create a Team Focused on Delivery
Once the product vision is defined, the risks are understood and mitigated and the design concept visualised and selected, then all stakeholders should commit to the development plan and delivering the agreed product. At this point it is essential that all efforts are focussed on all the activities that need to be completed before the product can be launched. The project plan should be revisited and updated on a regular basis and potential causes of delay identified and mitigations planned. Delays to decisions are a very common problem, particularly in corporate environments, where scheduling a meeting which all stakeholders can attend can lead to a delay of several weeks. Pre-scheduling meetings months in advance or assigning deputies can limit such delays.
At this stage, it is important that the project becomes the sole focus for the key members of the team responsible for driving the project forwards. Staff with other day to day activities will invariably get pulled away from the project causing inevitable delays. It is in these stages that it can sometimes be possible to accelerate the plan by adding additional team members. Ideally, these should also be solely focussed on the new device development. If problems with the development do occur, a dedicated team focussed on delivering the project vision will more committed and better able to create a rapid action plan to resolve the difficulties. A dedicated and motivated team can achieve more in one year than a disparate and distracted team would achieve in two. It is for this reason that medical device companies use external specialists like IDC to create the dedicated and focussed team to rapidly develop their innovative new products.
Stephen Knowles is the Managing Director of IDC. A chartered engineer with 20+ years experience leading technical and non-technical product developments in the medical industry. With a PhD in Mechanical Engineering and a thorough understanding of design and manufacture, Stephen is often invited to speak on the subject of product development.