By the time an idea or new technology reaches the hands of a surgeon, it has already gone through a lengthy innovation process. If it succeeds at all, as many promising innovations never make it to the finish line.
The Medical Delta Program ‘Medical Instruments Manufacturing: from Idea to Clinic’ (abbreviated as Medical Delta program 'MIMIC') aims to accelerate the innovation process of advanced medical devices and increase their chances of success.
Developing a new instrument that can be used in a clinical study is relatively expensive and risky. The Medical Delta program 'MIMIC' brings together expertise to facilitate innovation up to so-called 'first-in-human studies'.
To support this, the program launched a series of workshops last year. These brought the network together, with various stakeholders - sometimes even competitors - working side by side to move the sector forward. Rather than offering unsolicited advice, the program chose to take the questions arising within the network as its starting point.
Design agency Panton, as a consortium partner in the program, is closely involved in this process. Panton has extensive hands-on experience in guiding promising ideas through to eventual market introduction. Senior Product Developer Wilfred Teunissen hopes to use this expertise to support more researchers throughout the innovation process.
“To realize medical innovations, you need others to see what you do not yet know.”
This interview is the ninth in a series featuring practice partners from the transdisciplinary Medical Delta programs and living labs.
Can you tell us about your role within the Medical Delta program MIMIC?
“Panton is a design agency that contributes to the development of innovations in healthcare. These can include medical devices, but also services such as developing care transitions and redesigning patient journeys. We are also active in the field of prevention, for example by setting up programs that quite literally get people moving toward healthier lifestyles - whether in neighbourhoods or for employees within companies or organisations.
For everything we do, we take a bottom-up approach: working with the people who have a stake in it, while continuously keeping an overview of the objectives. We are particularly strong in analysing and identifying critical points, and then developing creative solutions to address them.
Of all the domains we operate in, ‘medtech’ (medical technology, ed.) is perhaps the most complex. This is due to the technology itself, which requires highly specialized knowledge, but also because of the heavily regulated innovation process, where requirements from many different perspectives must be met in the product being developed.
With the MIMIC program, we are still very much at an early stage. At the launch of the Medical Delta program MIMIC, we were invited to participate and help accelerate innovation. A defining feature of the program is that it is designed to be highly accessible and bottom-up in its approach.
We helped organize a series of workshops. The goal was to bring the network together and map out the entire process: what and who is needed at each step of the innovation process? We aim to build the network and, in particular, support researchers and start-ups. We also try to contribute ideas on how the MIMIC program could evolve in the coming period.”
In which phase of innovation does the Medical Delta program MIMIC aim to be involved?
“Typically, it goes like this: a scientist conducts research, comes up with an idea, and perhaps develops a proof-of-concept. Then it comes the point: what's next? How do you translate that into a product and a business? Through Medical Delta MIMIC, we primarily focus on supporting and guiding that development process. In other words, we are there mainly for researchers.
What’s important is that everyone has blind spots in an innovation processFor the business side, there are already other avenues for support, such as securing investments, but for the innovation process itself, there is less guidance. That’s where we want to help. What’s important to know, is that everyone has blind spots in an innovation process. Things you don’t anticipate or overlook, whether you’re an entrepreneur, a scientist, a healthcare professional, or a technician. You tend to view things from your own perspective, while the key is to bring together those different perspectives. The question is: what can you do yourself, and when do you involve someone else? And at what point do you make that decision? The Medical Delta program MIMIC aims to provide a platform for exactly that.”
You just mentioned that the Medical Delta program MIMIC is a ‘bottom-up’ program. How does that show?
“The starting point of MIMIC is to support the inventor. Often this involves very practical questions, such as: ‘When should I start documenting, and how do I actually do that?’ or ‘How do I know what surgeons want?’ or ‘How can I create safe prototypes that I can use for an initial study? Who can help me with development or production?’
This approach is different from looking at things through a theoretical model or tailoring an innovation process to fit a grant call with fixed policy steps. The accessibility of the Medical Delta program MIMIC lies precisely in looking at: what challenges are you facing right now? And then we develop a suitable solution based on that.”
How is the end-user involved in your program?
“Within MIMIC, researchers and early-stage start-ups are the primary target groups. So our ‘end-user’ is essentially the researcher who wants to become an entrepreneur or do something with their idea. The end-user of a device is usually a physician or nurse - they are also important and represented through network partners across multiple hospitals.
It starts by opening doors and getting to know one another
A question we often hear from researchers and entrepreneurs is: ‘How can we get our product prototype into a hospital?’. Capacity for this is limited, so together with hospitals we explore possible solutions. In MIMIC workshops, we learned that hospitals value being involved early on to assess the usefulness and application of a given innovation. Therefore, we could set up sessions with them where innovations are presented and evaluated against the hospital’s criteria.
An important goal of the Medical Delta program MIMIC is to make it easier to access each other’s expertise and to connect institutions for practical support. It starts by opening doors and getting to know one another.”
Do you have examples of such connections that have already been made?
“We have established strong ties with the Technology Transfer Offices (TTOs) of the academic institutions in the province of Zuid-Holland. We have also strengthened connections with universities of applied sciences and TU Delft, including through student projects.
The network is beginning to grow. You can see this in the workshops, where even competitors help each other and others find their way. We simply need a broad perspective to make faster progress.”
Earlier you mentioned briefly that medtech is the most complex domain Panton works in. Why is that?
“It’s because you need to understand both the technology and the treatment. The regulations for developing a safe and effective device, and the pathway to approval, are also quite complex—you have to prove that you meet all requirements and that the product does not introduce unnecessary risks. Within the innovation process, you must combine a wide range of requirements and translate them into a product that is safe, user-friendly, technically feasible, and economically viable.
The entire development process requires a transdisciplinary approach. Engineers, healthcare professionals, patients, investors, notified bodies for certification, distributors, purchasers, health insurers - you need them all at some point.
A healthcare transition can also be complex, but often stakeholders can be brought to a single table, and their interests are easier to map out. Compared to medtech, you’re dealing with fewer disciplines and requirements, especially when it involves technology that enters the human body, such as devices used to place a stent in a coronary artery.”
How do you help with turning an idea into a product?
“We work with a technology or idea until it becomes a product that can be used in everyday healthcare practice. Often, a technology is not yet a product. To move, for example, from a lab prototype to a tangible product, you need to consider production techniques suitable for larger-scale manufacturing. You also have to take into account safety, ergonomics, and usability, while keeping an eye on costs.
We help start-ups map out the steps that need to be taken. The experience we have at Panton in these types of innovation processes can be used to support researchers and start-ups within the MIMIC program.”
How do you incorporate feedback from clinical practice?
“The designer’s perspective can be well summarized by design engineer Kees Dorst, a professor in Sydney, with the so-called ‘designer’s paradox.’ He says: ‘You can only properly define your problem if you think about the solution. But you can only develop a solution if you truly understand the problem'.
In the beginning, you engage in conversations with, for example, the surgeon about what the product needs to do and what the user needs are. This serves as input for developing concepts or prototypes, which are then presented back to clinical practice. The feedback received from that process informs the next, improved version.
You also continuously check with clinicians: “Does this meet your needs?” This way, validation is ongoing throughout the process.Determining exactly which problem you are solving and working toward a solution go hand in hand. Kees Dorst refers to this as the ‘co-evaluation of problem and solution'. It is an iterative process: you continuously incorporate new requirements and arrive at ever-clearer definitions of what you want. You also continuously check with clinicians: “Does this meet your needs?” This way, validation is ongoing throughout the process.
How is this interplay between practice and innovation incorporated into the workshops and the program as a whole?
“We try to make it clear to early-stage companies that they need to look early on at what is truly desired and needed in the medical application. Sometimes a technological development may seem very efficient, but the actual clinical need can be a blind spot. The advice is to involve the target users at an early stage and ask them to observe and reflect.
The challenge with testing in practice is that in a clinical study, the test products must be completely safe and also identical to each other. These products therefore need to be manufactured in small batches according to all regulations, which is currently a significant cost. Through the program, we also try to find solutions to address this.”
It is notable that the program actively seeks collaboration between wo, hbo and mbo. Why is this so important?
“Because everyone has a role. A vocational graduate (mbo, ed.) can manufacture the instrument. The mbo students from LiS (Leidse Instrumentenmakers School, ed.) might go on to work in a production company. Many hbo graduates focus on development work, and the university of applied sciences needs practical cases to prepare their students for how medtech innovation works in practice. The university (wo, ed.) students are the potential researchers of tomorrow.
In the collaboration between wo-hbo-mbo and clinical practice, there is still room for improvement. The program identifies these points and actively seeks ways to bridge the gaps.”
What are the most important lessons so far?
“It has been mentioned a few times, but my main conclusion so far is that everyone has blind spots. You simply cannot know everything from all the disciplines involved. I see this in other collaborative projects and programs as well, but MIMIC makes it very clear. Thanks to the Medical Delta program, the importance of transdisciplinary collaboration is made explicit.
Thanks to the Medical Delta program, the importance of transdisciplinary collaboration is made explicitIn a sense, this is an open door that everyone can see, but at the same time, it is really both the problem and the starting point. For me, this is what defines why the Medical Delta program MIMIC exists and why the field needs it: to realize medical innovations, you need others to see what you do not yet know.”
What message would you like to give to the Medical Delta community?
“The main thing is: open the doors. Encourage cross-pollination, listen to others, and try to understand each other. There is enough room for everyone to contribute to meaningful innovations in healthcare.
I would also like to emphasize the facilitative role of the MIMIC network and the knowledge it provides in a broader sense. We have many strong institutions in this region, a lot of entrepreneurship, and extensive networks. It would be wonderful if these could also come together more top-down and reinforce each other in realizing healthcare innovations.”
Photo's: Guido Benschop
Text: Sietse Pots
