No limits: overcoming barriers to innovation

You may think that coming up with a killer idea is the hardest part of the innovation process, but there are many other potential barriers to turning your inventive idea into a market-ready product. We meet doctor-turned-innovator Will Nicolson and policy expert Herb Riband to hear about the issues that they think can limit innovation in Europe, and what you can do to beat them.

“When you have an idea, it’s easy to tell yourself that it couldn’t possibly work. So the encouragement to pursue different ideas is vital to help you progress,” says Dr Will Nicolson, Clinical Research Fellow at the Leicester Cardiovascular Biomedical Research Unit.

A cardiology registrar, Nicolson decided to take time out of his training to undertake a PhD with Dr Andre Ng, Senior Lecturer and Consultant Cardiologist at the University of Leicester. Looking for a clinical application for some of his supervisor’s basic science research, Nicolson and his colleagues have developed LifeMap™, a device that can help clinicians predict a potentially fatal disturbance in heart rhythm called ventricular arrhythmia.

Gaining support

LifeMap™ has won several prizes already, including a 2010 Clinical Impact Da Vinci Award, just six months into the project, and a Medical Futures Award for Best Innovation in Cardiovascular Diagnostics in 2011. What difference did this early recognition make? “It is a real challenge getting something like this to market,’ says Nicolson, ‘and the prizes we’ve won have helped enormously in getting interest and support.”

Recognition is not enough though, and Nicolson is quick to add that a base of expertise to draw upon is vital. He recalls a talk from the University of Leicester’s intellectual property team to a group of cardiologists: “I had just started my research, so this came at just the right time. When I had an idea that seemed a bit different, it was in my mind to ask if it could be patented. That was crucial – if we hadn’t got the patent at such an early stage, effectively everything would have been lost.”

For some fledgling innovators, the regulatory and approval aspects of device development can be daunting, confusing and distracting. The regulatory requirements haven’t been an immediate issue for Nicolson so far, but he is planning the next stage of the project with them firmly in mind. He will, for example, ensure the software language they choose is approved for use in medical devices.

Rules and regulations

“A clear regulatory pathway can be a help to an innovator,” says Herb Riband, VP, Legal and External Affairs at Medtronic International, “But an unclear pathway can soon become a barrier.

“An innovator may be looking for some technical assistance in terms of prototyping or critiquing a technology,” says Herb. “They’re going to want as much certainty as possible about what the requirements are for getting regulatory approval. If that pathway is clear then they can write a business plan and lay out what they need to achieve. That’s going to be very important to their ability to attract financing.”

He thinks that European regulation, while not a perfect system, is good and something that strikes a balance between safety, performance and innovation.

Things are changing, though. A review is underway at the European Commission, which will propose new medical device legislation later this year. “One of the big policy issues we’ve been working on over the past two years is how can we keep the basics of the current system, maintain its balance, but improve some aspects of it,” says Riband.

Prove your worth

Another potential hurdle for innovators – all the more pressing with the current austerity measures underway – is who is going to pay for a device, and how much? “Can you bring a new product to market that’s going to save money somewhere in the system or allow a more efficient use of healthcare resources?” says Herb. “It’s one thing to say it, but another to prove it.

“I think a lot of developers of technologies in the past didn’t need to worry about this, but today it’s critically important. I think you’ll see more and more people starting to think about how they’re going to make the economic case for a product.”

30/01/2012 | Posted by Medtronic
Tags: Innovation, Will Nicolson, Leicester University, Biomedical Research Unit, Dr Andre Ng, ventricular arrythmia, cardiovascular diagnostics, LifeMap, patents, medical devices, prototyping, pathway, Herb Riband, European regulations