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UK Medtechs Determined To Exploit Digital Health Opportunity Born From The Pandemic

New UK devices legislation, EU regulation and payment system changes must all be broached while COVID-19 continues to disrupt health care delivery

Executive Summary

COVID-19 has forced a rethink in how care should be delivered. Healthcomms Consulting partner Dan Jones says it is an opportunity that must not be squandered.

There has been no let up for the health care sector since the coronavirus arrived in early 2020, and that also goes for the wider health care industry, including service and information providers, and consultants, demand for whose expertise and insight has sometimes threatened to go off the scale.

That has been the experience of Healthcomms Consulting, formerly PB Consulting, which has adjusted its routine operations mix to accommodate the demands of the pandemic, both in terms of understanding what is happening on the ground and helping health care clients plot a course through uncharted territories.

Instead of the EU Medical Device Regulation and Brexit dominating the concerns of an increasingly  nervous health care products industry, as had been expected, it has been “COVID, COVID, COVID,” said Dan Jones. Jones is a partner in Healthcomms Consultancy, which underwent a rebrand in fall 2020, the very time when talk of the second spike was changing from “if” to “how big.”

“Right now, people are trying to get a handle on what’s going on with the spread of coronavirus,” said Jones. In that respect, the EU-UK free trade agreement (FTA) at the tail end of 2020 has helped smooth the general trading situation for the present, although there is still a long way to go in terms of the detail for medtech and wider UK business. (Also see "UK/EU Free-Trade Deal Sees Hopes Of Mutual Recognition Of Medtech Regs Fade" - Medtech Insight, 30 Dec, 2020.)

How the UK National Health Service and individual companies and their staff are being impacted by the pandemic is currently the major challenge. Reports on 14 January of an NHS waiting list of 4.46 million (in November 2020) for those waiting to start hospital treatment in England has underlined what president of the Royal College of Surgeons of England Neil Mortensen described as the “calamitous impact of coronavirus.”

“The sector is now looking at June, July or August at best before there is an NHS return to normal.” – Dan Jones.

Last year, NHS chief executive Simon Stevens set ambitious post-COVID aims of a 90% return to routine NHS working by November. Now, however, the UK is back in pandemic crisis mode. Not much progress has been made by the NHS in its plans to provide side-by-side COVID care and elective surgery. With over 30,000 hospital beds in England occupied by COVID patients, the national provider is having to retreat a little on cancer therapy provision. (Also see "COVID-19: UK NHS Chief Calls For 90% Return To Planned Care Within 3 Months" - Medtech Insight, 11 Aug, 2020.)

The sector is now looking at June, July or August at best before there is an NHS “return to normal,” Jones speculated.

Building On The 2020 Digital Uptake

But looking past the gloom of the pandemic, there is an opportunity to be seized, said Jones. “We’ve completely changed the health service, and we don’t want to see it snap back to exactly what it was” pre-pandemic.

The ability to do things differently and better, in areas such as use of minimally invasive technology and treatments, and treating people more quickly with fewer appointments and using digital tools more fully, have been shown to work. “This approach must be embedded as good practice for the future.”

In late 2020, Jones and team worked with the Association of British HealthTech Industries (ABHI) on creating a Digital Health All-Party Parliamentary Group (APPG) to develop the opportunities that a proper digital infrastructure would bring. It would examine all the benefits to be derived from digitally enabled devices, data, communication and sharing information electronically, in an aim to reduce in-person clinical consultations.

The initiative fits squarely with the NHS Long Term Plan’s aim to use digital health technologies to support health care delivery, identify unmet needs, measure outcomes and shape services. The digital health sector is already the largest employer within the UK healthtech sector, employing 12,900 staff and making annual turnover of £1.7bn ($2.3bn).

The APPG, chaired by Dean Russell MP, will bring together parliamentarians and senior health and technology leaders. Other officers of the APPG are Anne Marie Morris and Greg Smith, both MPs, and Lord Hunt, who was a House of Lords spokesperson for health and social care until 2018. The ABHI will provide the APPG’s secretariat.

If this is one positive to emerge from an unwelcome situation, then another must be that the traditional winter flu season, which in mid-2020 had been expected to exacerbate lingering COVID infections to create a second spike, has not materialized. The wearing of masks, social distancing and work-at-home edicts have prevented flu from becoming as rife as normal.

Non-COVID Medtech Concerns On The Agenda

Alongside their COVID-19 preoccupations, UK medtechs await the enactment of the Medicines and Medical Devices Bill. The UK’s new standalone legislation remains in the House of Lords report stage but is not expected to change dramatically now, said Jones. Its apparent delay is procedural, and not particularly bound up in Cumberlege Review considerations. The bill is currently expect to emerge around February-March. (Also see "UK Device Safety To Be Enhanced By Patient Safety Commissioner" - Medtech Insight, 14 Jan, 2021.)

On the EU FTA front as regards medical devices, Jones’ noted that the UK medtech sector had become resigned to no form of mutual recognition of devices addressed being addressed during the high-level trade talks. Industry has understood for quite a while that the UK would have its own regulatory system, and companies have been preparing accordingly over the past two years or more.

“What people in the UK want now is a regulatory system that does not require hugely different processes to the EU system,” said Jones. As of 1 January, under the new system, the Medicines and Healthcare products Regulatory Agency has documenting the products that are on the UK market. In addition, more UK product registries are planned to capture data and information about patients, procedures and products. There is already a good model for this in the almost two-decades-old National Joint Registry (NJR), said Jones.      

In short, UK medtechs are now getting used to a system they did not press for, but are keen to identify the positive elements to take advantage of.

Elsewhere, companies in the UK market must keep an eye on planned changes to the payment systems for medtech products within the NHS. There are expected to be far-reaching changes in 2021, said Jones, referring to the establishment of integrated care systems and the move away from the traditional Clinical Commissioning Group-hospital model, under which hospitals have been paid according to levels of activity undertaken.      



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