Tell us more about IBI and why did you decide to found the firm?
IBI (Industrie Biomediche Insubri SA) was a crazy idea that came up in the past from the brains of two “drunken” postdoc guys in London.
I have a master’s degree in bioengineering and courses from the medical faculties, as it was a twin programme. I then got a PhD in industrial engineering and physical chemistry, with a focus on translational regenerative medicine. Gianni, the other founder, holds a PhD from King’s College. At the time we were in London, and we decided to do something when we would have returned to Italy.
Both our families have an entrepreneurial background. At the same time, we are both interested in translational research. We also have complementary backgrounds and competencies. We said, “let’s start”, and everything started just like that.
In our field, it’s easy to find tons of papers on possible ideas of innovative medical devices for tissue engineering. That includes lab tests, cell tests, etc., but very little get to the animals and almost none gets to the patient. A tiny minority of these finally gets stably into the market.
I have a strong belief from a philosophical and technical perspective, that I’ve embraced since almost 20 years ago—we should try to ‘heal’ the patients and not to just ‘repair’ them. This is not just a semantic exercise or Oxfordian English.
It’s essential because ‘healing’ means that I restore and help the body to self-restore by providing support through scaffolding technologies and others; while ‘repairing’ sounds more like a mechanic repairing the window, the gearbox of the modern bike using spare parts or whatever. In the last decade, these slight differences are becoming quite evident as we move from ‘repairing’ to ‘healing’, together with the trend in regenerative medicine.
Gianni and I said that we should do something in the field of bioengineering and regenerative medicine, indeed, but not just in research. It should have become a business in the long run. And of course, the bone district has a huge market potential, and from an anatomy and physiology perspective, it’s relatively easier when compared to the other parts of the body.
We bought an existing small company that was almost an empty box, some years ago, with just some space and a couple of labs. We revamped it and made it into a new entity. Over time, we grew with a garage science approach. In 2011, we got the first robust preclinical results with our bone graft material.
We met Lorenzo Leoni at the time who was just coming back from the States to Ticino. He was running the sovereign investment fund of the Canton Ticino (at that time “AgireInvest”) and said that he was looking for start-ups where he can put money into. We said that we’re looking for money, and that we could be the start-up that he invests in. Everything started from there.
We started the first clinical trial early 2012, got the first CE mark end of that year and we continued growing all the way. Now, we are still at a small stage, battling in between the market and the pandemic, the new rules to certify our products, and other daily challenges. We’re growing, manufacturing bone grafts and selling them in roughly 30 countries through distributors.
Can you share some challenges that you’ve faced?
The major challenge is the never-ending changing regulations in Europe. We recently got another change with the lack of a bilateral agreement between Switzerland and Europe which is quite a nightmare.
Once you get ready after one year of work, then you discover that something has changed again, as every notified body sees things differently. We are now thinking of expanding into foreign markets like China and the U.S. where it is more straightforward. It doesn’t mean that it’s easy, but they do have clearer processes.
The second big challenge that we face daily is in managing human resources. It’s not easy to find good compromises in managing people, finding the right person, and putting them in the right place.
What has been some highlights so far?
Some have been severely critical because we have been walking through all the changes in the regulatory framework in Europe. We succeeded and already got the first transition to MDR, but it was a tough job.
Other highlights are our clinical results. I remember that it was 2016 Christmas time, when we performed the first oncology paediatric patient (a compassionate case). At that time, some people told us that we were totally crazy, and that the success didn’t make much sense, and it could have been just a lot of luck.
But at the end, when we reach more than 20 paediatric oncology patients and they all go along really well, then it’s no longer luck. It’s just design, commitment, performance, safety, etc.
In the major application fields, we are happy to say that we are one of the few manufacturers who have 0% failures in orthopedy. When I say zero, it is not just a low number, but truly zero, full stop.
We also have very nice published papers, and we are growing in research at the same time. We have developed the next-generation product which is meant to work in traumatology and even better in the paediatric oncology space. When you have results and you make top level publications with top level European Brands, this is certainly a highlight.
Congratulations. Can you share some lessons learned?
Open an ice cream shop. Do not start a medtech company. 😉
Did you always know you would become an entrepreneur?
No, I wanted to have a gasoline shop when I was a kid and I regret not following through with my real intentions! 🙂 Everything in life has its pros and cons, and each one brings a lot of potentiality and other good things.
Particularly in our field, satisfaction comes from the patients’ results. And I would say that it is something really strong.
What is your view on failure?
I have two answers for this. You know the quote ‘failure is not an option’ by Gene Kranz from the Apollo 13 story, who was the flight director of NASA. But failure is part of the game for you to grow and understand, and you cannot say that “I’m failure-free”.
And of course, if you think of the quote that I just gave you, it’s really a challenging quote. On a practical perspective, very little is considered to be a clinical failure. However, if we gave patients hope and are unable to meet it, whether it’s a small piece of a jawbone or a massive bone tumour in the leg, then I would consider it a very heavy failure.
I always wondered if the company, from a business perspective, doesn’t grow as our investors expect – Is this a failure? From their perspective, it is. But I can tell you, we have had so far 80,000+ satisfied patients who received our graft, and I’m really happy with that.
So, it depends what you focus on. Nevertheless, failure is part of the game. You can fail an audit, fail a recertification, fail a grant, they can reject your paper, etc. It happens to everyone.
Any advice for other scientists looking to become entrepreneurs?
Yes, open an ice cream shop or something similar! Do not start a medtech company in Europe now. 🙂
I mean, if you do so, get yourself really well-prepared to fight a lot of audits, to fill tons of papers and battle bureaucracy. A lot of people will question you, either it’s the investors, the notified bodies, or the competence authorities, but nobody’s asking us if this really works. So, you must be quite tough and crazy.
Did you always know that you are tough and crazy?
Crazy, for sure. I can sign it with my blood now in front of any public notary. I knew that I am tough, but sometimes I ask myself why didn’t I just end up being a happy university professor but choose to put myself through these challenges every single day.
There’s an old quote from one of the very last real prime ministers in Italy, Luigi Facta, and it’s been almost a hundred years now. He asked why an entrepreneur would wake up and turn on the lights in his company and start fighting against bureaucracies, taxes, rules, competition, unfair markets, and syndicates; when he could take his money and invest it in more relaxing solutions that would get at least the same or even more money with less issues, problems, and concerns.
And he said, look, it’s because they are doing it for something else. Because they consider what they do as a personal success, others for their own ego, others because they believe in what they do, others because they think it’s a social mission, etc. It could be a mix of these.
I think in every one of the crazy ones, as we are, it is a mixture of these things. We do it for several reasons. I would suggest to any other potential entrepreneur to stop thinking that much and just live with some kind of unconsciousness. And go. Trust me, go.
What is your hope for IBI?
We have a strategic plan which sees a certain degree of growth. The future in our field is usually to go into M&A, or grow by purchasing or listing. In the long run, we expect the company to keep growing and become interesting internationally. There are different options on the table when it comes to the ‘when’, ‘why’ and ‘what’.
Anything else to add?
Remember the ice cream shop. Keep it seriously in mind. 😉