Gwenael Hannema is the co-founder and CEO of InnoSpina, a medtech device start-up that develops unique surgical guiding instruments, novel implants, and a minimally invasive implantation technique to make spinal treatments safer, faster, and more accessible than existing procedures.
After graduating from EPFL as mechanical engineer, he cofounded 3DDynamics, a technological start-up accelerating the Additive Manufacturing adoption by providing cutting edge 3D printing, design, and numerical simulation services. Previously during his Master thesis at the Monash university in Melbourne, he developed a numerical model to study arterial stability and its impact on specific cardiovascular conditions. This was the starting point where he realised he needed to combine 3D printing, numerical simulations and the medical field to kickstart his entrepreneurial journey.
Tell us more about InnoSpina.
InnoSpina is a medtech device startup founded in 2017, dedicated to advance minimal invasive surgery with motion preserving and fusion technology for disorders of the spine. We design and develop new implants and surgical guiding instruments to enable surgeons to treat chronic back pain in less than 30 minutes.
Lower back pain is the leading cause of non-fatal health loss worldwide and is drastically impacting people’s quality of life. Disorders of the spine such as degenerative disc disease, narrowing of the spinal canal (stenosis) or spondylolisthesis (slipped vertebra), may result in severe back and leg pain.
In the US alone nearly 2 million people need to undergo surgery each year. Spinal fusion is one of the most common types of surgery performed and consists of connecting two or more vertebrae to improve stability, correct a deformity or reduce pain. This procedure typically involves placing pedicle screws and short rods in the treated segment for spinal stability. It is a complex, multiple incision and time-consuming procedure associated with high risks and long recovery time.
Considering the costs and risks, with the current high entry barrier, only a fraction of the patients get access to the care they need. InnoSpina is on a mission to change that. With our technology we ensure a safe and accurate positioning of our implants with a single incision, simplifying the surgical act and drastically reducing the operative time.
How did this come about?
At the beginning, I was in contact with the founder from 3D Precision, an additive manufacturing service provider, when I created my first start-up 3DDynamics which failed. I was motivated to start over again having learned a lot with this first endeavor.
In 2017, I co-founded InnoSpina with Dr. Jacques Samani a world-renowned spine surgeon and Nicole Beuchat to leverage our combined skills and expertise. Initially we worked on our other jobs and progressively I reduced my employee activity at Empa. Finally in 2020, after I secured 1.3MCHF in non-dilutive funding I joined InnoSpina full-time to drive the startup forward.
Where does this entrepreneurial spirit come from?
When I was young, I always wanted to create something from scratch with my own hands, putting pieces together and trying to invent new things. After finishing secondary school in 2007, I hesitated between studying surgery or engineering. I finally decided to go for the second option and studied mechanical engineering at EPFL.
With my Master’s degree in my pocket I realized that the engineering background greatly enhanced my toolbox and this motivated me to explore the bumpy road of entrepreneurship. In 2014, I started 3DDynamics, my first startup with one of my friends. We were enthusiastic and tried to dive into the entrepreneurial scene without experience, background and know-how, but we were eager to learn.
Back then with the rise of numerical simulations and the freedom of design offered by new 3D printing methods, we decided to combine these two fields and create a startup that would bring the complex ideas of its customers to life. 3DDynamics was a technological start-up accelerating the Additive Manufacturing adoption by providing cutting edge 3D printing, design, and numerical simulation services. Unfortunately, we didn’t manage to convince investors with our business plan and business model, but we learned a lot during the process, and I wanted to start over again.
Although I do not come from a family of entrepreneurs, I’m grateful that my parents always motivated us to pursue our dreams and take risks, always telling us to simply try. Being in this journey, I can tell it’s a bumpy road, but I believe it’s worth trying, and pursuing the goal of positively impacting a patient’s life is something that really motivates me on a daily basis.
What is your view on failure?
Especially in Switzerland, I think we approach failure as something negative. I would rather see it in the opposite way, even though on the spot it may hurt and may feel uncomfortable, I always try to extract some learnings and not repeat the same mistakes in the future.
What I find interesting is being able to share my “failure” story with other founders and learn from each other, avoiding some of the pitfalls on the road towards entrepreneurship and to be able to fast track startup development. Approaching failure in a positive way and trying to apply what Will Smith says, “fail early, fail often, fail forward”.
Can you share a highlight?
One of the highlights of the company was when we conducted the preclinical test on specimens (cadavers) with Dr. Samani and we were able to place the implants in less than 30 minutes in a safe and repeated manner. This was one of our main goals and it laid the foundation of the ongoing developments.
It was exciting to witness the potential of our technology and it was one of our great achievements so far.
Congratulations! You were also one of the 10 medtech teams for this year’s Venture Leader program.
Thank you. It was a truly enriching experience, being able to share and get feedback from other founders, learn from their development journeys, what they have done to build their teams and attract talent and how they grow the company spirit and vision. It was also a fantastic opportunity for InnoSpina to pitch to top-level US investors in preparation of our upcoming Seed round.
There were 70 startups at the start of the process, and I was fortunate to make it in the top 10 and to be chosen by the jury. I’m happy I was able to participate and get exposure in the US which was extremely beneficial for the company.
Where is InnoSpina at today?
Currently we have two projects that are running in parallel. Our surgical guiding instruments is a platform enabling the surgeon to deliver two types of implants.
Our first implant is a fusion implant that targets the most severe conditions and is supported by the economic promotion from Canton Jura. We are also developing a motion preserving implant to address less severe conditions with an embedded sensor. This development is supported through an Innosuisse project assisted by 4 R&D engineers from our academic partners. In total, 1.3MCHF in non-dilutive fundings has been secured to date to develop our products.
We are finishing the development of our fusion implants and will operate a design freeze of our second product by Q4 this year. We must then go through all the regulatory challenges, targeting the US for our first product as it falls into a Class 2 device in the US versus Class 3 in Europe making it more challenging to get a CE mark. Therefore, we will launch in the US first.
This was also the reason why InnoSpina participated in the Venture Leaders Medtech program to better understand the US medical device ecosystem and refine our go to market strategy.
Best and worst part of being a CEO.
The best part is being able to develop products that can positively impact people’s lives all around the world. It’s a long and challenging but rewarding journey to answer an unmet need by bringing an idea from the initial concept to the final product on the market.
One of the worst parts is bearing the weight and responsibility when something doesn’t go to plan. If things go wrong, it’s your responsibility no matter what happened. And having to lay-off employees either because you didn’t manage to secure the funds on time or due to other reasons is something that I will never enjoy as part of my job.
The biggest challenge is that the regulatory process is extremely long, tedious, and costly. It is frustrating that despite having an innovative product that can have a big positive impact on patients’ lives and which has already received traction from spine surgeons, we must go through extensive clinical trials, typically five years, before we can get it on the market.
What has been the biggest challenge so far?
The biggest challenge is that the regulatory process is extremely long, tedious, and costly. It is frustrating that despite having an innovative product that can have a big positive impact on patients’ lives and which has already received traction from spine surgeons, we must go through extensive clinical trials, typically five years, before we can get it on the market.
What drives you?
To have an impact and help people is a universal driver and greatly motivates me. To think that a couple of years down the road, I will be in the surgical operation room with my co-founder Dr. Samani, being able to treat the first patient who will come in for a 30-minute surgery and walk back home on the same day is extremely motivating.
Can you share a lesson you have learned?
Ask people and reach out to more senior guys who have been through the process and have the experience. Don’t be afraid to ask.
I also try to put myself into more uncovered ground, stepping outside of my comfort zone and fail more often to learn faster.
What are your hopes for InnoSpina?
Looking at the short term, I hope to secure the upcoming seed round and close it by Q3 this year. This will enable the company to reach our next value inflection point and start the US market launch for our first product by Q1 2024.
For the long term, I hope to be able to get our product across many patients who are currently in pain. I hope that InnoSpina will be successful, and that I will have the financial means to be able to start over again.
I would like to have an impact on another continent – in particular South America as I traveled there a lot in the past – and to be able to start other projects and help people there.
You studied mechanical engineering and now you’re in the life science field. Has this interest in the life science space always been there?
I was always interested in the life science or the medical space. Before starting mechanical engineering, I wanted to study surgery. During my Masters, I spent seven months in Melbourne and had the chance to develop a numerical model to study arterial stability and its impact on specific cardiovascular conditions.
This was the starting point where I realized that I had to combine these two fields of interest and it’s extremely rewarding to have founded a startup in the medical field.
Any advice for other new entrepreneurs out there.
Just try, it doesn’t matter if you fail. You will learn so much along the journey in such a short period of time that it’s more than worth it. Everybody should go after their dream, and a quote from Mike Horn, a South African-born Swiss professional explorer and adventurer that resonated with me was – we all have roughly 30,000 days in our life, and we should use them to pursue our dream and to make an impact, whatever it is.
Define your own goals and vision. If you have this feeling inside you that you must do something, just do it. It’s really a rewarding journey.