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#NHSScot70 Innovation Series: Colin Morgan, Director and Vice Chair, SHIL Board

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Medical devices and diagnostics play a key role in delivering new products that benefit the NHS, the economy and above all, patients. With some 80,000 different types of devices and equipment used in UK hospitals, GP surgeries, residential care, and in patients’ homes, the market is vast.

The last 50 years have brought about significant medical advances and the medical device market has been revolutionised. While the first whole-body MRI scan in the world was only conducted in 1980 at University of Aberdeen; Glasgow is now home to a £32million Imaging Centre of Excellence (ICE) featuring the world’s most powerful MRI scanners. On a smaller scale, but no less important, laparoscopic surgery, commonly known as keyhole surgery, was first conducted in the UK at Ninewells Hospital in Dundee with the removal of a patient’s gallbladder. It has since revolutionised most disciplines of surgery as well as the patient experience and is now in routine use across a range of surgical procedures.

Against this backdrop of continuous medical innovation, over the last 15 years, SHIL have tapped into the talent and skills of health professionals across Scotland supporting them to develop a range of medical products and devices to drive improvement in the value and quality of patient care. These range from simple devices such as the Rhinopinch (Class I medical device) which is a simple nasal clip to staunch nosebleed through to PEEKaBoo (Class I medical device), an app for testing visual acuity in children.

Delivering expert innovation services to NHS Scotland: find out how SHIL drives innovation in healthcare

The challenge today is keeping up with the rapid advances in technology. Wearable tech, ehealth, mhealth, and telehealth are revolutionising healthcare and blurring the boundaries between science, technology and manufacturing. But with a vibrant and growing medtech sector in Scotland, world-class expertise and facilities, dedicated innovation centres such as the Digital Health and Care Institute and a wealth of successful companies including SHIL spin out’s - Touch Bionics, Clear Surgical and Ambicare – we have the ability to position Scotland as an internationally leading centre of medical device innovation.
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As part of our NHS at 70 Innovation Series, we talk to Colin Morgan, Director and Vice Chair of the SHIL Board. With 36 years spent with the Johnson & Johnson Medical Device Companies in the UK and Ireland; Honorary Fellowships from the Royal College of Physicians & Surgeons of Glasgow; the Royal College of Surgeons Edinburgh and the Association of Surgeons of Great Britain & Ireland and an OBE (2008) for services to the Medical Device Industry, Colin’s vast knowledge and experience across UK and international markets guide our work at SHIL.

 

The medical device market has changed dramatically with advances in digital technology transforming healthcare, what are the most significant changes you have seen in the medical device market over your career? 

“Of course in recent years, implantable and wearable tech has generated a lot of attention with many large and influential companies such as Apple, Nike and Samsung all developing medtech devices and digital applications. These, without doubt, have the opportunity to transform healthcare by providing vast amounts of health data and empowering patients to manage their own health. Similarly, robotics, artificial intelligence and digital manufacturing such as 3D printing are experiencing growth and development which I have no doubt will continue to influence the delivery of healthcare in the future. These are all hugely exciting areas and therefore generate a lot of attention, however, we shouldn’t become nonchalant about the innovative devices and technology already in use every day throughout the health services.

Advances in technology and visualisation equipment have transformed devices that were previously only capable of being used in ‘open surgery’.  The “scope” be it laparoscope, endoscope or arthroscope revolutionised surgery allowing the development of minimal or no access surgery. Whilst the driver for change was technological capability, surgeons and physicians were quick to see the advantages for patient care, a reduction in hospital stays, and patients themselves seeking quicker recovery times. This medical advance really was transformative for our health services and I often recall speaking to a surgeon in the later stages of his career who claimed the advent of Laparoscopic surgery was the single most exciting thing that had happened to surgery during his career.

The transformation is perhaps most optimised in the field of cardiovascular treatment - it was only 50 years ago that the first heart transplant with open heart surgery was performed; yet now, minimal access medical devices allow many cardiac and vascular interventions, for stroke treatment or heart attacks, to be done within a day.

It is a proud history of medical innovation and whilst we must continually evolve, explore new opportunities and capitalise on technology advances, we shouldn’t forget the innovative practices in use every day in our health service helping to transform patients’ lives.”
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Are there risks associated with the proliferation of mobile technology?

“Others are better placed than myself to speak directly on mobile technology but looking at the broader issues, in principle, my opinion is yes. Combining healthcare and digital technology, offers innovative ways to manage the current and future health challenges but technology should always be seen as an enabler only, not the entire solution - people and processes are key. If we want people to use digital technology to support their healthcare, we must understand how people use the tools (patients and clinicians), what barriers may exist and what more is required to connect people to their health and care digitally. Health is an area where people are very engaged and in that respect, we are very fortunate – but we do need to have mandated standards in terms of expected outcomes and reducing variations across the health system. Tens of thousands of new medical apps are now available. To be effective and importantly safe, clinical development and endorsement are vitally important. This is applicable to any medical devices which should be trialled and tested.

Steps have been taken by NHS England to create a library of NHS endorsed apps. This is important as it can be a challenge for clinicians to consider data from a health app that has not been prescribed, endorsed or recommended in any way - the clinical integration into current systems does not exist so it does not feed into any sort of clinical pathway, and that doesn’t even begin to touch on information governance issues around safe and secure data. Then, of course, we cannot expect all patients to adopt digital or mobile technology. Some demographics will not engage and we must remain mindful of this.

It’s easy to be seduced by the possibilities of mobile technology but it should be approached sensibly to ensure proper application into the health service in a way that is useful to all stakeholders. I also stress that innovation is not all about technological solutions. This is evidenced in some of the products and spin out companies supported by SHIL. For example, Clear Surgical – its range of innovative medical devices are used in operating theatres to improve the efficiency of the surgical procedure and so improve the potential outcome for patients and with application across other sectors including veterinary and military.”
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What do you see as the biggest opportunities and challenges around medical device innovation?

“The opportunities are vast and with many large and influential, yet non-traditional, companies such as Apple, Nike and Samsung all developing medtech devices and digital applications, there is no shortage of vision, entrepreneurs and expertise to drive this.

This coupled with an increasingly ‘digital life’ means our patients will have high expectations of how technology can be better adopted in the health service. It is routine to use technological solutions in other sectors – banking, retail, hospitality but the consumer experience in healthcare is rather complex. So whilst not negating the opportunities to advance our healthcare system, the single biggest challenge to medical device innovation is its routine adoption throughout health systems – and that is not just in Scotland, it applies globally.

A more general point is that one single technology or innovation will unlikely be as transformative as some in the past – take the heart-lung machine or the coronary stent as examples. Generally, each “new” device is likely to need a “companion technology” to drive its use and effectiveness. We are already seeing this in the field of personal diagnostics and precision medicine whereby integrated solutions need to include digital and data handling technology. Scotland is already doing great work in this area to push our expertise and capabilities and it will be inspiring to see advances in more targeted approaches to medicine.”
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With the sector experiencing such growth, medical devices must meet strict regulatory requirements – how does SHIL support this?

“The Regulatory requirements for Medical Devices is frustrating for companies in the sector, large and small, as these requirements and standards can vary around the world, although some commonality exists between the two largest jurisdictions - the EU MDD and the US FDA. But such has been the proliferation (and success) of new technological solutions,that the regulatory system has struggled to keep pace with any potential associated risks.

Having supported a number of products and devices through the regulatory process, SHIL has vast experience and can advise and guide health professionals, resolve challenges and generally make this process as efficient as possible. This includes advice  critically supplied very early in the development cycle on the information required to obtain “approval” to market, as well as advice such as notifying the competent authority, or appropriate classification of the medical device.

SHIL also has a broader role in understanding how the Regulatory landscape is evolving around the world and their dedicated experience and expertise on a national level is very beneficial to NHS Scotland.”


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