30th January 2019

Into 2019: Intelligent Innovation’s Role In The Shape Of Medtech Things To Come

Executive Summary

Brexit, the “Implant Files” and the new EU regulations – however large they loom at present, they will in time be seen as mere tactical challenges for a global medtech industry working hard to ensure that it is ready for the massive health-care delivery and service-oriented changes to come. Preparing for the future and maximizing current market penetration – in the UK, the EU and beyond – were key themes at UK HealthTech 2018, held in Cardiff, Wales.

Health-care delivery is changing at an ever-faster pace, and predictions made now for four years hence may well prove to be inaccurate. Such is the lot of those who set themselves the task of looking into the future.

Deloitte’s UK Centre for Healthcare Solutions’ Mark Steedman took up that challenge this year in co-compiling the flagship “Future Awakens” report, Deloitte’s attempt to char how health care will look in 2022. He gave an update on his thoughts regarding the shape of medtech things to come at MediWales’ annual UK HealthTech conference on Dec. 4 in Cardiff, UK.

The Deloitte report is a study of current health-care trends and a distillation of the findings into six key themes that the consultants believe will have a major influence on the market by 2022. It is an “optimistic view of the future,” Steedman, research manager at Deloitte UK, told the UK HealthTech audience. The six themes are based on “pockets of evidence” around the world that will or might scale in 2022. He believes the changes ahead will be influenced by the arrival or ongoing exploitation of:

  • The genome generation – i.e. the “quantified self” –  taking ever greater control of their own health, including via lifestyle and weight-loss app-based programs, such as OurPath. (Also see “Test Beds, Digital Hubs And Innovation Tariffs Top Medtech News At UK’s NHS Expo” – Medtech Insight, 15 Sep, 2017.)
  • Digital technologies transforming health care – where smart health care is delivering patient-centered solutions ever more cost-effectively.
  • The industrialization of the life sciences, with AI and cognition technologies increasingly standardizing processes.
  • Data becoming the “new health-care currency,” with AI and real-world evidence unlocking the value in health data.
  • “Futuristic medicines” such as CAR-T therapies penetrating markets more aggressively (CAR-T could become a $35-100bn market in 10-15 years’ time, Steedman believes).
  • The tech giants playing an ever-bigger role in health care, pointing to last year’s JP Morgan Chase, Berkshire Hathaway and Amazon tie-up. (Also see “New Mega Health-Care Trio Offers Opportunity For Digital Sector” – Medtech Insight, 30 Jan, 2018.)

The key enablers for these six predictions are more conventional: skills and talent; targeted technology; and suitable and empowering regulation.

The Tech Guys Are Coming

Speaking to Medtech Insight, Steedman said the remit of the Amazon/JPM/Berkshire Hathaway venture is still not defined precisely, even if the CEO and COO have now been installed. The name of the venture has also not been announced. But, rest assured, “The tech guys are coming and we’ll see a lot more of this.” (Also see “Winning the Medtech Vs. Tech Battle: Five Lessons Learned From Tech’s Success” – Medtech Insight, 29 Nov, 2018.) There has been much collaboration already, and both pharma and medtech companies are keen to see what they can do with more data-driven companies, said Steedman, using Roche and Flatiron as an example. (Also see “Roche To Improve Real-World Cancer Data Extraction With Flatiron Buy” – Medtech Insight, 21 Feb, 2018.)

The big tech companies are asking themselves, is health care “growth-worthy?” says Deloitte’s Mark Steedman.

“It’s a change of business model, and the routing of technology companies into health care is inevitable. The big companies have got to be interested in health, but they are asking themselves: is it growth-worthy?” While the detail surrounding the Amazon venture remains something of a blur, it is considered that the business will have crossed a threshold when it reports on its first delivered outcomes.

Meanwhile, forward-thinking providers are not waiting to be invited to the party. Steedman pointed to the example of the Mercy Virtual Care Center – a building with 300 care staff but no patients and no beds, as a well-reported example of disruptive change in the delivery of health care. Based in Missouri but reaching across 43 hospitals in five US states, Mercy delivers telehealth care to bedside clinicians, primary providers and specialists in a bid to maximize patient data in real time.

MHRA – The Regulator’s View

Back in the UK, digital-health capabilities are seen to hold so much promise that some believe digital and data “might just be the savior of the NHS as we know it,” said Mark Birse, group manager of medical device safety surveillance and software and apps for UK MHRA, the country’s device regulator. The sense is that the markets are reaching a tipping point in digital health, although it remains difficult for some commercial players to grasp the opportunity, Birse told the Cardiff audience.

The MHRA would like to see itself as a “one-stop shop for digital,” but on an operational level, the agency faces a major challenge in “selling what it is doing” to users. Part of its offering is to act as a conduit for accessing the Clinical Practice Research Datalink (CPRD) databank of anonymized clinical data, which sits within the MHRA.

Life Sciences Regulation In 2028

“Life Sciences Regulation” in 2028 is the subject of another new report from Deloitte’s Centre for Health Solutions. It makes four predictions for the next decade:

  • More alignment of regulation globally;
  • Regulatory functions will be seen as a strategic asset;
  • Data-driven approaches will become commonplace for faster approval of products; and
  • AI will be an established tool to improve the quality of regulation.

The MHRA is also working with NHS Digital to design synthetic data sets that can be used by companies developing software apps to validate their software. Another part of the agency’s offering its innovation office (IO), which has been in operation for five years already it is a virtual office administered by a combination of experts within the 1,500-staff agency on a needs basis. To date, the IO has fielded 600 enquiries, a third of which have been on medtech themes.

Brexit An Ongoing Concern

It is a busy time for the regulator, with the twin challenges of Brexit – and associated “no-deal ” planning – and the EU MDR and IVDR, set to take full effect in 2020 and 2022, respectively, to prepare for. On Brexit, Birse said, “We continue to plan for all eventualities as an agency.”

Brexit was – intentionally or otherwise – all but absent as a theme during the main body of the UK HealthTech meeting. Instead, speakers broached many other UK-based areas of industry focus, including the NHS England Long Term Plan (expected imminently), which is expected to address digital data and technology work streams, and updates to the Life Sciences “sector deal” (posted on Dec. 5).

Post-meeting, on Dec. 7, UK Secretary of State for Health and Social Care Matt Hancock issued an update letter to the UK health and care sector, providing new thoughts on the effects of a no-deal Brexit on the supply of devices and pharma goods. A worst-case scenario would see significantly reduced access, for up to six months, across the short English Channel crossing routes, he said, adding in a statement that alternative routes are being investigated to ensure there is enough capacity to allow the  flow of “these priority products” to continue unimpeded after Mar. 29, 2019. ( (Also see “UK Government Prioritizes Medical-Device Transport In No-Deal Brexit” – Medtech Insight, 10 Dec, 2018.))

Taking Due Note Of The ‘Implant Files’

In the final session of the UK HealthTech 2018 meeting, the “Implant Files” journalistic investigation was raised as a theme by a floor questioner who wonderied why more attention had not been given during the day to the global breaking story and its implications for medtech innovators and regulators. Medtech Insighthas covered the story, and an ongoing appraisal of the situation suggests that the industry has so far not been knocked of the rails by the critical reporting from the International Consortium of Investgative Journalists (ICIJ), which produced the ongoing project in collaboration with mainstream news outlets around the world.

Part of the reason for the somewhat contained reaction is that this is very much familiar territory to the industry, if apparently not to the ICIJ. Greg Crist, chief advocacy officer of US industry association AdvaMed, said as much this week: “There isn’t a lot that’s new in the reporting that should raise concerns about patient safety based on the current medical device regulatory system in the US,” he told Medtech Insight. (Also see “US Medtech Lobbyists Say They’re Not Worried About Political Backlash From ‘Implant Files’” – Medtech Insight, 9 Dec, 2018.)

“It is one of the constraints of life that people in this industry go through,” says medtech industry veteran John Jeans of the “Implant Files.”

In Cardiff, session chair and veteran of the device industry John Jeans (former roles at Amersham and GE Healthcare, among several senior postings) indicated to Medtech Insight that the sector is not underestimating or overestimating the ICIJ’s claims. Jeans, chair of the Scottish Digital Health and Care Institute, called out the criticism leveled at what the public might see as early EU access to untested devices. The EU and US industries are duly concerned, he stressed, but he considered that such claims will never go away. “It is one of constraints of life that people in this industry go through.”

Many point to the EU MDR (2017/745) as a means of giving additional muscle to EU regulation. Or is it over-regulation?  The MDR is proving to be a challenge for manufacturers inasmuch as it tends to up-classify risk rather than down-classify, which has been a more obvious trend at US FDA of late. That observation was made by MEDDEV QA’s Simon Richards, who also said that companies will need to supply more clinical data, now that this approach has been formalized in the MDR, where it had previously been in in MEDDEV guidance 2.7/1 rev. 4. Periodic Safety Update Reports (PSURs) are also coming into the MDR, bringing the need for annual updates; as is the installation of a person responsible for regulatory compliance at medtech companies. These new stipulations, which could conceivably slow down innovation, were ignored by “Implant Files” reporters, he argued.

Making Way For The Value Proposition

But UK stakeholders are trying to do what they can to support innovative medtech. Sheryl Warttig, who heads HealthTech Connect, the NHS England-funded, NICE-hosted information source on technologies and products (diagnostics, wearables, devices) made a request for companies whose products provide additional benefitsto step orward and input their technologies onto the system. It’s basically a way of demystifying the value proposition of a product, she said.  Meanwhile, the NHS supply chain is trying to introduce notions of value into NHS procurement buying.

Health Technology Wales and Life Science Hub Wales

Health Technology Wales, the local counterpart of NICE, has been in existence for one year, with a remit of not duplicating the work of NICE – and adopting it unless there is a justification as to why this should not happen. HTW is hosted by Velindre NHS trust, and has 15 staff who have produced four pieces of guidance in year one, on: cardiology, diabetes, ophthalmology and management of incontinence. Elsewhere, the Life Science Hub Wales is having a renewed push to insert itself more fully into the local and regional medtech innovation stakeholder system. See:

But the problem, as West of England AHSN innovation and growth director Lars Sundstrom sees it, is that “we still don’t understand where innovation fits into the system.” His advice to innovators is that they should try to support clinicians by “designing things people want to use”, and by making it easy for health care systems to adopt them. Maybe the biggest way to harness innovation is to “bring people with you.” The current five-year plan for the AHSNs includes the intention to combine them together in a national network.

Future Orientation

If he had a wish, Sundstrom would do away with the transactional nature of NHS buying and adoption, which he believes remains a huge barrier to innovation being taken up. But there will be a greater drive to foster a climate of partnership between business and health care in the future. Hamish Lang, of Swansea University school of management, suggested that in the future it would be a world where clinicians will become interpreters of information.

Wales’ Plan for Health and Social Care (issued in summer 2018) sets an aim to increase the value achieved from funding of health and care through improvement, innovation, use of best practice and eliminating waste. This is described as a “quadruple aim,” although it differs slightly to Royal Philips’ take on the same concept. However, it does set the context for value-based health care and the drive to deliver better outcomes at reduced cost.

Steedman said medtech’s future role in this shifting landscape will be major. “Medtechs are transforming health care, going from innovative product suppliers to insightful partners.” But the challenges remain huge – including interoperability of devices, new funding and business models and secure data needs. These are predictions Deloitte makes in another of its new reports, on “Medtech and the Internet of Medical Things (IOMT),” an ecosystem that will be valued at some $158bn in 2028, up from $41bn in 2013.