UK doctor outlines concerns with medical device development
In an article, in The Guardian, Dr Susannah Clarke outlines her concerns over product development in the healthcare market and explains how she got from idea stage to patients
Around 160,000 total hip and knee replacement procedures are performed in England and Wales every year.
Current instrumentation is standardised, using a one-size-fits-all approach, despite the fact that bone shape and size can vary widely between individuals.
Clarke says she first noticed an opportunity to improve this approach when she was studying for a PhD in orthopaedics at Imperial College London.
She told the newspaper she had set up Embody Orthopaedics in 2012 to use 3D printing to create surgical instruments tailored to the individual patient.
The minimally invasive devices assist surgeons to p osition joint replacements precisely, and improve recovery times.
Getting from idea to patient is not a simple process as healthcare is very tightly regulated.
This need for stringent regulatory approvals and clinical trials means medical entrepreneurs can face years with minimal income, a major hurdle for small businesses or entrepreneurs.
Clarke says she tackled this by selling print time on Embody Orthopaedics’ 3D printer, and making 3D models of bones to help medical practitioners plan surgeries, allowing her to bring money in before the core product was ready.
Clarke also successfully applied for a Royal Academy of Engineering Enterprise Fellowship in 2012, which gave her a huge boost in terms of opening doors to new connections, as well as training, mentorship, funding and support from the Enterprise Hub.
In the UK, the NHS is the largest potential customer for medical entrepreneurs but, according to a recent independent review, while most medical device companies want to work with the NHS, they find it difficult to do so.
The medical industry has long sales cycles, and selling into a hospital can take more than 12 months.
Clarke told the newspaper that healthcare professionals are sometimes considered technology-averse, so entrepreneurs need to communicate the benefits in terms professionals are concerned with: tangible health outcomes, financial impact, process and resourcing efficiency.
Clarke recently received the Royal Academy of Engineering silver medal, which is awarded to technology entrepreneurs who have achieved commercial success.
This shows it is possible for medical entrepreneurs to overcome the barriers and maximise their chances of success.
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 for joint replacements.