By James Scott, CEO and Co-Founder at Orthofuse
When people talk about innovation, the idea tends to get most of the attention. It is the breakthrough, the thing that is easiest to explain. But once you try to turn that idea into a business, the technology quickly becomes one piece of a much bigger puzzle.
That is particularly true in medtech, where bringing an innovation to patients means thinking about intellectual property, regulation, clinical engagement, reimbursement, manufacturing, investment and team building alongside the technology itself. Commercialisation was always the objective for Orthofuse, so the focus was never simply on developing the product. The challenge has been understanding how all of those pieces fit together.
As an engineer, I find that side of company building interesting. Engineering is ultimately about solving problems, and building a business applies the same mindset across a much broader set of questions. Product development remains central, but it sits alongside decisions about adoption, evidence, markets and the people needed to move the company forward.
Putting the pieces together
One of the biggest lessons from building Orthofuse has been how interconnected those different workstreams are. Early on, product development, IP, regulation and commercial strategy can look like separate tasks. In practice, decisions in one area often shape what is possible in another.
A regulatory decision can affect product design. Clinical feedback can reshape the commercial proposition. IP strategy can influence investment conversations. Progress is rarely linear, which means founders need to understand the wider picture rather than treating each challenge in isolation.
That also makes the people around the business extremely important. No founder has deep expertise in every area, particularly in a highly regulated industry. Building a strong network of clinicians, advisers and specialists gives you access to perspectives that can improve decisions and help identify issues earlier. The MSK Accelerator was valuable to us because it provided exposure to the complete innovation pathway. It created opportunities to discuss strategy with experienced founders, investors, clinicians and industry experts who had already navigated many of the decisions ahead. For us, the value was in broadening our understanding of how the commercial, clinical and regulatory elements interact.
Technical founders will naturally spend a great deal of time on the product because that is where their expertise sits and where progress can feel most tangible. But even excellent technology needs the right foundations around it if it is going to become a sustainable business.
Investment is one of those foundations, but it works best when the other pieces are moving with it. Raising capital is important, yet funding does not answer questions about regulation, clinical adoption, manufacturing or commercial strategy. A stronger position is created when those areas develop together and investment can accelerate an already coherent plan.
Choosing the right route to market
Commercialisation also means thinking carefully about where a technology may have the greatest impact. Healthcare innovation is inherently international, and different markets offer different routes to adoption, regulatory requirements and commercial opportunities.
It is easy to frame this as a choice between building in the UK or looking overseas, but the reality is more nuanced. The UK has significant strengths in research, clinical expertise and early-stage innovation support. As companies grow, however, it also becomes important to understand opportunities across a range of markets and the different commercial, regulatory and clinical considerations they bring.
The US may offer attractive opportunities for one technology, while another business may find a different route makes more sense. There is no single formula. The common objective is ensuring promising technologies ultimately reach patients, and that means making informed decisions about where and how to commercialise.
Across all of this, founders do not need to become experts in every discipline before taking the next step. What matters is recognising the breadth of the challenge and surrounding yourself with people who strengthen the areas outside your own expertise. A strong network of mentors and advisers can provide perspectives from people who have encountered similar situations before, helping founders make better-informed decisions as the business develops.
For me, that is what commercialisation has come to mean. The technology remains at the heart of the company, but success depends on building the right structure around it: strong clinical relationships, informed advice, regulatory and commercial understanding, investment and a team capable of bringing those strands together.
The idea may be where the journey starts. Putting the rest of the puzzle together is what gives that technology a genuine opportunity to reach the patients it was designed to help.
