The medtech masters: How Sagentia Innovation is easing the path to market
Masterclass: What does it take to develop and commercialise a medical device and how can we speed the process up? Editor Paul Brackley talks to Duncan Smith – a judge in the Cambridge Independent Science and Technology Awards 2023 – and learns about the best strategies, the trends and the pitfalls.
Bringing a new medical device to the market is no mean feat, but there are ways to smooth the path.
Duncan Smith, managing partner for medical at Sagentia Innovation, heads up a team that helps companies bring their innovative medical technology to patients and clinicians quickly and safely.
“We help companies with their most business critical technology challenges – the ones they can’t solve in-house but which make a difference to their markets and their patients,” Duncan tells the Cambridge Independent.
Duncan works with medical device companies in areas such as surgical robotics and diagnostics, including half of the top 20 medtech companies in the world. Meanwhile, his colleagues in Sagentia Innovation also work with many of the world’s largest brands and organisations in consumer, industrial, defence, and food and beverage.
Intriguingly, Duncan brings a whole other skillset to the medical field.
“I’ve got a consumer electronics background,” he says. “I’m a relative latecomer to medical, but that background has given me a real interest in three areas where consumer brands tend to lead over medical companies.
“One is user centricity – focusing on the needs of the patient, or the clinician or the surgeon, as a priority.
“Adoption of digital is another area where having a consumer background is useful. I’ve seen digital technologies and hybrid-digital technologies adopted very rapidly in the consumer sector, but it’s not quite there yet in the medical world. It’s coming.
“Also, sustainability – where consumer brands have been quicker to adopt net zero sustainability strategies than medical companies.
“So that’s what I hope to bring to the mix in the medical team, alongside my stalwart colleagues who have worked in medical devices for 30 years.”
Between them, they are adept at helping companies – from start-ups to blue chip household names – which typically require different approaches to navigate the many challenges of devising, developing and commercialising medtech.
“It’s different working with a start-up to a big company and we’re lucky enough to work with both,” says Duncan, who was on the judging panel for the Cambridge Independent Science and Technology Awards 2023, at which Harston-based Sagentia Innovation is sponsoring Medtech Company of the Year.
“At the front end, large organisations often need outside eyes on their strategy, for example, to work out how to build technologies from other industries into their world.
“Often they have M&A activities, because medical companies often acquire rather than invent technologies.
“When bringing technology from outside, it’s not just the usual due diligence you would do as part of an acquisition. Often companies are buying into really early demonstrators, so the technology is not even proven. It might require very experienced eyes to work out what would be required to take that all the way to market successfully.
“And, of course, for medical companies there is the added need to understand the regulatory approach and reimbursement: how your product is going to get paid for eventually.
“That drives the challenge at the early stage of the process – really pre-development.”
Having established what to develop, the next step is a proof of concept, which Duncan describes as “a demonstrator that shows the hard science could actually work and meet that need”.
“The hard science is at the core of what we do and what differentiates us,” he explains.
“But it’s not only about science breakthrough, it’s about having a scientific approach to other important elements such as the needs of the user, whether that’s the patient or clinician, who are equally important in our view. The business case is extremely important and something we take care to discuss with our clients – making sure that you’ve got the right value proposition, and ensuring there is a balance between that, the technology feasibility, and the commercial viability of any venture.
“We are part of Science Group which is an international science, engineering and technology (SET) business providing a range of services and products. Where appropriate we can call upon our colleagues in our sister businesses to help consider the many aspects required for our clients to achieve clinical utility and commercial success.
“The best projects that we work on have a good focus and balance of those elements; the user, technology feasibility and commercial viability.”
If the middle section of product development takes you to a compelling proof of concept, then the final stage is getting to market.
“The biggest challenge is predictability. That is all about having a strong risk-based approach – building a team that understands how to tackle the biggest risks in getting to market first, whether that is a technology risk or navigating clinical trials to prove safety and efficacy.”
Then you need to understand how to secure regulatory approval and get difficult products manufactured, to achieve this we work closely with our sister company, TSG consulting, which offers a deep regulatory knowledge and understanding of local nuances and experts in navigating the complex and ever-changing regulatory landscape across the globe. It’s all about getting the right team around you and trying to minimise risk and make the process as predictable as possible.
“It’s a ‘safe pair of hands’ approach. That’s where the biggest differences are between start-ups and blue-chips – the teams they have available to make that predictable,” says Duncan.
And he has some sage advice for those earlier-stage companies making their first forays into medtech – and it starts with getting in touch early.
“It doesn’t cost anything to call us and have a chat,” he points out. “There is an impression that consultants will send an invoice straight away. But we definitely like to talk to people and understand where they are coming from and see if we are the right fit for where they are.
“You can raise money through personal vision, belief and charisma, but you can only make money through teamwork, pragmatism and patience.
“Have a vision but accept you’ve got to build a team around you with a range of skills and they are going to be critical friends for you.
“I would say that, as we are critical friends for hire, but it is so important.
“We see start-ups who think they can do everything all at the same time, but picking the right first application for their technology and getting to market quickly so they generate revenue is the best thing they can do.”
This is often driven by a gap in the market – and user needs.
“It might not be the breakthrough, but if there is an unmet need and we can see a path to revenue, that will buy us the time to do the really killer app. That is not specific to medical, but more acute for medical companies because the costs and risk are higher, and there is more challenge with the regulatory side,” Duncan notes. “We love entrepreneurs with vision, but you need pragmatism too.”
Some start-ups seem to take years to bring that exciting vision to reality, getting mired in seemingly endless refinements. How can we speed up the process?
“Firstly, do your homework. It’s important to have the balance between technology, the user or patient/clinician need and the business case. Make sure you’ve done equal amounts of homework before you’ve even started,” says Duncan.
“What slows development down is change. If you’re able to get your early stage and proof of concept right, you’ll be able to have a very straight line through the expensive bit, which is the development and scale-up of the product. Changes during those later processes are expensive, because by then you’ve got a bigger team and third parties involved.
“Reducing risk sounds really dull, but I’m afraid it’s key to speedy product development.”
But there is also a major opportunity in medical to embrace new technologies too.
“At the moment, there is a reticence to embrace digital technologies but we are seeing companies benefit from doing so and taking advantage of the power of data. We have a rapidly increasing data science practice here. There is so much more focus on data and using that as a tool to build better products and get to market faster.”
And that, after all, must be better for everyone.
Supporting the Cambridge Independent Science and Technology Awards 2023
Sagentia Innovation is sponsoring Medtech Company of the Year at the Cambridge Independent Science and Technology Awards, being held on May 18 at the Faculty of Science and Engineering, Anglia Ruskin University, in Cambridge.
Nominees get free tickets, with limited number of other tickets now on sale, priced £35 plus VAT and booking fee. You can buy them via Eventbrite here.
“It’s important to us to support the Science and Technology Awards,” says Duncan. “It’s a great event that highlights and celebrates some of the most exciting research and development projects in the local area, of which there are many, and the focus on scientific and technological advancements aligns perfectly with our belief that a deep scientific approach to medtech innovation is key.”
Five trends in the medtech sector
What can we expect to see in medtech in the coming years? Duncan is witnessing several key trends.
The first – artificial intelligence – isn’t new anymore, but it is becoming integrated in more interesting ways.
“AI has been part of medical systems for years. It is used to identify the difference between cancerous and non-cancerous cells for surgeons, to improve their decision support,” notes Duncan.
Now we’re seeing AI used with surgical robotics – a related trend.
“People tend to think of robots as autonomous, something driving themselves and going off on their own.
“But of course that’s not what they do in surgery. They are all about aiding surgeons to do something that is otherwise really difficult, with enhanced dexterity and accuracy.
“That trend is continuing – using robots and AI together to improve guidance systems and allow surgeons to get to places they wouldn’t otherwise get, so they can carry out operations more efficiently and improve patient outcomes.”
Sagentia Innovation has recently been working with a client focused on total knee replacement surgery.
“Your knee is very complex. There is an awful lot of very subtle movement and control going on in there, so to replace that with a metal implant is very challenging.
“Our client is working on a brand new system to make that a lot more accurate and efficient for the surgeon replacing the knee. It’s a good example of combining robotics and navigation in surgery,” says Duncan.
“Another big trend is hospital-to-home. It’s not just a reaction to Covid. Within this trend, there are point-of-care and point-of-need diagnostics – bringing more of the lab to the patient, rather than the other way around.
“It is a huge trend and it can reduce the overall cost of care and improve outcomes. The whole industry is about that.”
Bringing hospital standard care closer to home is not simply about performance, but improving access and inclusivity in testing.
“For example, breast screening is currently expensive and cumbersome. Can we use technology to reduce the cost, reduce the invasiveness and improve accessibility? That could have huge potential impacts on patients,” says Duncan, who notes that sustainability will become another major trend in medical.
“Net zero healthcare is a long way off,” he observes. “The healthcare industry worldwide is responsible for about four per cent of greenhouse gas emissions – so it’s basically the size of a large country in terms of its impact.
“At the moment, it’s not top of the list. You often hear medical companies saying the patient outcome outweighs the sustainability considerations, but we are starting to see it impact a lot more.
“The NHS in Scotland has just banned a specific anaesthetic – desflurane – because of its environmental threat. When we look at toxicity of chemicals, we’re not just worrying about toxicity to people but also to the environment. In that case, it was about 2,500 times more impactful than carbon dioxide.
“These things are starting to make a difference. The people who buy products from medical companies care about sustainability.
“It’s about much more than lateral flow tests and disposable plastic. That’s part of it, but only a fraction of the challenge we’ve got to get to net zero.”
Personalisation is, of course, another major trend.
“It is about technologies that enable personalised medicine to tailor treatments to very individualised needs based on their genetic make-up or physical make-up,” says Duncan.
Converging technologies are driving this trend, such as the molecular diagnostics and PCR testing notable for their use during the pandemic.
“We all got used to PCR in Covid, but it has so many more applications,” notes Duncan. “Being able to be very specific about a diagnosis based on an individual’s genetic make-up is becoming mainstream now.
“And the trend towards liquid biopsy means being able to carry out blood tests or other non-invasive tests for diagnostics that would previously have required a hospital visit.
“It’s huge in terms of the impact of getting people out of a hospital and to a clinician nearer to them.”
Two case studies
Sagentia Innovation’s product knowhow covers the full pathway, from prevention and early-stage diagnostics through to treatment and aftercare.
genedrive came to Sagentia Innovation for help with developing its low-cost, low complexity molecular tuberculosis (mTB) diagnostic system.
It needed to ensure the cost of both the cartridge and instrument was low enough to be affordable in the intended lower income markets and decentralised settings to diagnose TB infection and provide drug resistance information to clinicians.
Sagentia Innovation focused on the design and development of the sample preparation instrument and disposable cartridge and produced a proof-of-principle system.
“It’s a good example of a test that was previously expensive but made much cheaper and decentralised,” notes Duncan.
Sagentia Innovation also worked with Smith & Nephew to develop an advanced negative pressure wound therapy system.
The company wanted to know whether the device could be made smaller and quieter, and what battery-powered vacuum pump would enable such performance improvements.
Aimed at helping patients with their post-operative wound care, Sagentia Innovation mathematically modelled sources of loss and inefficiency in potential vacuum pumps and, having discovered no suitable off-the-shelf pumps, developed a range of bespoke concepts using structured innovation techniques, before taking the development through to transfer to manufacture.
“Wearables are often thought of as sensors, but they also go through to therapeutics,” said Duncan. “This advanced wound care system, called PICO 7, applied negative pressure to wounds using a vacuum pump to promote healing. It was discrete enough and small enough to be worn under clothes.
“Being able to carry that around makes a massive difference to patient wellbeing and outcomes.”