Of all the scientific developments that have been made over the last century, those in the medical field could be said to have had the most impact on our lives; improving diagnosis and making treatment more effective giving us healthier and longer lives.

Recent technological advances in smart materials, big data and miniaturised electronics promise to further revolutionise healthcare, and there are large numbers of medical entrepreneurs taking these innovations from lab to market, working to make them better, cheaper and more accessible.

Developing medical technologies can be hugely rewarding. I find it really fulfilling to design something that people really use and depend on. However, the field of medical entrepreneurship can also be very challenging. My own technology improves joint replacement procedures through 3D printing surgical tools tailored specifically to the patient, rather than a ‘one size fits all’ approach. I have encountered many barriers in getting this technology into hospitals, but I’m proud to have ultimately overcome them.

So, for those looking to help shape the future of healthcare, here is my guide to overcoming the challenges of being a medical entrepreneur.

Be prepared for a lengthy regulatory process

Healthcare is a very tightly controlled environment and gaining regulatory approval for your products or services can be considerably more difficult in healthcare than it is for consumer technologies. It can take many years, and requirements vary from country to country.

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Medical entrepreneurs must thoroughly research exactly what they need to do to get their product or service approved in each territory they wish to operate in. The UK Government, European Commission and World Health Organisation all have guidelines that are a good starting point.

Although demanding, regulatory approvals are essential and this higher barrier for entry can ultimately be beneficial, as it can prevent you from losing out to lower cost but potentially lower quality competition from other regions of the world, where manufacturing may be cheaper. It also benefits the patient through consistently high standards of treatment.

Secure revenue early

The need for stringent regulatory approvals and clinical trials means medical start-ups can face years with minimal income. With my company, Embody Orthopaedic Ltd, we diversified our offerings from an early stage to secure a revenue stream while trials were still ongoing. Selling print time on our 3D printer, and making 3D models of bones to help medical practitioners plan surgeries, allowed us to bring money in before the core product was ready. At the same time, we were able to raise our profile among our intended customer base early on.

Securing grants and getting business support from those who have expertise in the field can also be a particularly good route for medical entrepreneurs; there tends to more available in this sector since developing new medical technologies has demonstrable societal impact.

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I successfully applied for a Royal Academy of Engineering Enterprise Fellowship in 2012, which gave me a huge boost in terms of opening doors to new connections, as well as training, mentorship, funding and support from the Enterprise Hub. Applications for the 2016 Enterprise Fellowships are currently open, so I’d certainly urge any medical entrepreneurs looking to get their technology to market to consider applying, as this was a real game-changer for me.

Know your audience

In the UK, the National Health Service (NHS) is the largest potential customer for medical entrepreneurs but, according to a recent independent review[1] whilst most medical device companies want to work with the NHS, they find it hard due to barriers like a disjoint between local and national organisations, budget siloes and long decision making processes. Recent figures[2], show that 85% of UK entrepreneurs feel that NHS procurement processes are too complicated. Unlike in other industries where the user is often also the budget holder and decision maker, the decision makers in healthcare are rarely the users of products or services. Budgets are also fragmented between different hospitals and trusts.

With so many diverse stakeholders involved, when building a business model medical entrepreneurs need to look beyond the immediate buyer and consider the impact of their technologies or services on different groups, from hospital management to patients, carers, and health professionals.

Reinforce your sales pitch

Even when you have a business model you are confident with, you still have to actively sell your product or service. The medical industry has long sales cycles, and selling into a hospital can take more than 12 months. Healthcare professionals are sometimes considered technology averse, so influencing them to buy into new medical technologies requires entrepreneurs to communicate the benefits in terms they appreciate most: focus on tangible health outcomes, financial impact, process and resourcing efficiency. The medical industry needs proven data, and client references and case study examples can provide useful evidence.

Healthcare remains a challenging market for entrepreneurs. However, there is evidence[3] that the NHS is increasingly working with external partners and there are always opportunities for entrepreneurs with technologies that can make a difference. I recently received the Royal Academy of Engineering Silver Medal, which is awarded to engineering entrepreneurs that have achieved commercial success, and really goes to show that it is possible for entrepreneurs in healthcare. By taking the above factors into consideration, medical entrepreneurs can overcome the barriers involved in the sector and maximise their chances of success.

About Susannah

Dr Susannah Clarke is Founder and Director of Embody Orthopaedic, a spinout from Imperial College London, which is pioneering a new type of 3D printed technology to revolutionise joint replacements.

Further reading: What kind of entrepreneur are you?

[1] Accelerated Access Review: UK Mapping. March 2015 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/444246/AAR_UK_Mapping.pdf

[2] ‘The NHS must keep its pledge to embrace tech entrepreneurs’, The Guardian, November 2013 http://www.theguardian.com/healthcare-network/2013/nov/25/nhs-pledge-tech-entrepreneurs-start-ups

[3] ‘Arms race over £5bn in NHS work’, Financial Times, July 2013 http://www.ft.com/cms/s/0/6424b29e-f60a-11e2-a55d-00144feabdc0.html#axzz2lr8VGEER