Sometimes as a medical device development consultant, what we bring to the table isn’t a tangible hard skill or capability – though we also bring those – but an understanding of what it takes to get a medical device or combination product to market. Less ‘what to do’ and more knowledge of the journey. How to think about, approach, and take something from lab to approval and market.
Having a map gets you where you need to be much faster than defining the route as you go, and in medical device or combination product development, time and resources are precious.
These experiential topics are not typically what organisations seeking medical device product development, or regulatory/MDR/IVDR consulting come explicitly asking for, however, but they are often the biggest value that experienced medtech consultants provide.
One of these ‘softer’ topics is the importance of being able to tell the story of your device. To be clear: though this is a ‘soft’ topic, it doesn’t mean addressing it doesn’t lead to hard results. In this case the opposite, effectively telling the story of your device is crucial at every stage development. It just means its one of those intangible topics that is typically learnt through hard won experience.
Narrative Needs in Regulatory Approval
As an example – storyboards came up a few weeks ago when I was taking part in a talk organised by Health Tech Hub Copenhagen and given by the EU notified body Scarlet. In this case Scarlet explained that one of the biggest things likely to lead to questions, non-conformities, or delays for a device undergoing IVDR or MDR approval is a scattered submission that fails to join the individual pieces up into a holistic whole.
What a notified body seeks to understand when reviewing your submission is that the device in totality is safe and effective within the intended use, with an acceptable risk/benefit profile for patients.
Simply filling in each expected element in an MDR or IVDR application may provide this, or it may not. Effective regulatory affairs is not a tick-box exercise, but a strategic tool. However, the way we approach medical devices and regulatory affairs often encourages us to act like it is; with siloed capabilities, regulatory input as a late-stage add-on rather than a supportive structure, and an attempt to do the minimum needed to get our devices onto market.
This approach is frequently a false economy. When regulatory affairs is not a strategic exercise, it’s possible to give all the required information to your notified body, and still fail because nothing is tied together in a way that notified bodies can engage with and understand.
That means questions, which in turn means cost, delay, and risk (or in the worst case the need to go away, re-build, and re-submit). A smooth path to approval relies not only on being able to provide data, but narrative, explicitly tying everything together in a clear structure that describes why your device should be approved – the requirements to be met, the work done alongside its justification, and the outcome of the work with the argument sufficient to demonstrate a safe and effective product.
Storyboards throughout the development journey
As a medical device manufacturer, you need to be build effective narratives that describe the value of your medical technology or combination product, and how it is delivered, throughout your product development journey. The ability to build these narratives is often the difference between success and failure in the medtech or combination product space.
Other stages in the journey where narratives are crucial include:
Investment: When investors support a company financially they are buying that company’s story. Does the narrative justify an existing market that value can be delivered into? Can this value be captured effectively by the company/product and create value back to the investors? Can the product be developed effectively and within a reasonable budget? Are the team capable to pursue the development? These are all questions asked by investors that must be answered via a clear and coherent narrative. Failure to do this means failure to fund your product journey.
Development: Equally crucial, is the narrative behind your development path itself. What are you aiming for the product to achieve, and why? How does this make commercial, technical, and regulatory sense? What needs to be done and why? Constructing a clear narrative behind your development keeps your activities focused and on target, enabling you to pursue a timely and efficient path to market. Failure here looks like long development journeys that never build a successful product
Reimbursement: Approval is not the end of a device journey. Even an approved device must be commissioned, reimbursed and purchased by a health system to deliver clinical value to patients and financial value to you as a manufacturer. This also relies on narratives. What does your product mean for patients in practice? What does it mean for the health system? Do they need to change or stay the same? How is the cost of your device justified against the value delivered? Health Technology Assessments are essentially a tool to interrogate the narratives around the cost and value of a device and so make an informed decision on whether it is valuable, including for what level of reimbursement. Failure here looks like approved devices that never get purchased or reimbursed by a health system
Use: Lastly, effective narratives around device use are crucial. Even once a device is acquired, paid for, and in the patient hands; if the patients don’t understand what is expected of them, how they should use the system, and the value they receive and the costs they should expect, then it can still lead to failure. Patient perception needs proactively managing, and this is done via narratives. Failure here is a widely available devices that patients don’t use.
What becomes clear is that building effective narratives also requires understanding of your stakeholders, and what they value. In all examples above an effective narrative articulates the needs of stakeholders and describes why the product developed meets those needs; delivering value, in a way that justifies the cost (financial and non-financial) incurred.
This is not a siloed exercise – an effective narrative integrates the commercial, technical, and regulatory device aspects (the medical device ’troika’) into a single description of value delivered and how it is achieved.
How to begin building better Medical Device storyboards
All of which serves to outline the challenge, but what about the solution? For someone who hasn’t spent years ‘in the trenches’ of medical device development – how to begin constructing narratives that lead to successful investment, development, regulatory approval, and adoption leading to financial success? Here are some ways to get started
To learn, do: As with any skill much can be done with practice. The key is to practice the right thing. The narrative around your product is not a simple elevator pitch. It’s important to link from detail on your stakeholders, and what they value, right through to what your product does and how it delivers that value. Once you have this detail, it’s always possible to abstract it to something shorter if needed.
Test your messaging: Alongside practice, testing is hugely useful. Particularly helpful is to test your messaging with people who don’t know the medical device space. If they don’t understand some aspect of how your product delivers the value claimed, its likely one or more of your key stakeholders may not too. Use the feedback from testing to refine your storyboard/messaging.
Find out what your stakeholders value: Storyboard are about justifying the value that you deliver to stakeholders, and to do that effectively, you need to understand what it is they truly value. This means understanding who your stakeholders are as well as going out and talking to them. The more you can hear what they value, the better you will be able to target your messaging.
Explicitly map your features to stakeholder needs/value: Following talking to your stakeholders, it’s important to map their needs against the features of your medical device that meet them, alongside what elements of your device success they have influence over. For example, practitioners love high efficacy, low safety, and ease of use – but typically don’t make purchasing or reimbursement decisions. Those that do, health systems, value clinical effectiveness over clinical efficacy, as well as complete system costs. Mapping who your stakeholders are, where they are relevant, and what they value is crucial for building the right narratives around your medical technology that lead to success.
Interrogate the commercial, technical, and regulatory aspects of each decision: The key elements of any medical device storyboard and strategy are the commercial, technical, and regulatory ones. Where development often goes wrong is in not effectively addressing all three of these. For example, taking a core technical concept and adjusting it to be as fast as possible to get through regulatory approval, but in so doing losing any commercial advantage. The more you get into the habit of ensuring your device addresses the complete ‘troika’ of needs, the greater your chance of success becomes.
Get Help: If you’re still struggling, get help. There are a wide variety of experts available who can help you develop the right storyboard for each stage of your product development.
Summary
The ability to tell the “story” of your medical device is essential to success throughout your development process. From getting your initial investment, to achieving regulatory approval, and making sales, the story you’re able to tell about the value your solution delivers to stakeholders is an enormous driver of success.
This is not typically a taught skill however, but something learnt through the trial and error of taking medical devices or combination products from initial idea through to market and aligning the medical device ‘troika’ of commercial, technical, and regulatory elements. It is however a skill that it is possible to practice and develop with focus and time.
Are you seeking ways to better include narrative and storyboarding into a successful device development program? Feel free to message us here for a 1:1 no-obligation chat to see how we can help you
Or find out more at www.fullspectruminnovation.com