Wolfgang Emmerich, CEO of Zühlke UK, creator of the UK’s test and trace app, highlights emerging trends in medical technology.
Government projects, new medicine development and the introduction of new medical devices are three things which have been commonly known for moving slowly, often glacially – that was until 2020 and the arrival of COVID-19.
Public and media pressure to accelerate innovation quickly mounted as the world was put into lockdown. Solutions had to be found swiftly. Disruption can be the innovator’s friend, and the impact of the pandemic in terms of forcing everything to be done differently has been profound – and it will continue to have a profound impact on every aspect of the healthcare system.
Medical technology (medtech) developments were already gaining momentum before the arrival of COVID-19, but we will look back on the pandemic as creating the circumstances that will unleash an even faster acceleration of medtech development and adoption, leading to dramatic and far-reaching changes to every aspect of healthcare delivery.
Over the next 10 years many aspects of healthcare will change beyond all recognition. It will no longer be a case of traditional healthcare augmented with a few extra clever apps and devices. Instead, we will see mobile medical technology increasingly bringing together a wealth of data for immediate analysis by Artificial Intelligence (AI) to help prevent illnesses, diagnose patients, and aid medical professionals with their treatment monitoring. Patients, doctors, nurses, scientists, researchers and pharmacists will all find medical technology driving changes to their roles – and, most importantly, better patient outcomes.
There are several elements to this. The first was the way in which many countries around the world immediately saw data and apps as part of the solution to containing the virus, with huge political pressure for the rapid creation of ‘test and trace’ apps for people to use on their mobile phones.
Test and trace
Zühlke UK developed the test and trace app for Britain’s National Health Service. It was created within 12 weeks under demanding and rigorous conditions and registered with the UK regulator the Medicines and Healthcare products Regulatory Agency (MHRA) as a class 1 medical device.
The app has now been downloaded by over 22 million people, and its usage data was recently analysed by Oxford University, in association with the Turing Institute (the United Kingdom’s national institute for data science and artificial intelligence), to investigate its efficacy. They estimated that from its national launch at the end of September to the end of December 2020 it helped prevent up to 600,000 infections. The same research also found that every 1% increase in usage of the app reduces infection rates by 2.3%. Similar apps in other countries, such as Germany and India, have also had very high download rates, reinforcing that – for all the media attention on the vocal few obsessed with conspiracy theories – most people are happy to use such technologies.
To unpack the important elements from this: complex medical apps can be created, approved and deployed very quickly where there is the will and skill to do this; and they can quickly have a major public health impact, in this case in making a major contribution to reducing the spread of a dangerous disease. On top of this is the issue of cost effectiveness. It is crucial to understand that the cost per user of an app is several orders of magnitude smaller than that of a device built into dedicated hardware.
Low cost, high investment
Our engineering budget to build the NHS app was less than 50p per user. The distribution and operation costs are in single-digit pennies per user per month. This renders the ‘app as a medical device’ paradigm very financially attractive, because if an app can be used instead of custom-built hardware the cost will be orders of magnitude lower. Even if the app is used as a companion device, it will still substantially reduce the bill of materials for the medical device; as expensive user interface modules will not be required and the device can use smaller amounts of memory and lower-spec central processing units. This combination of low-cost, verifiable patient results, alongside the major return on investment, will attract the attention of both investors and national healthcare systems to apps as medical devices.
Investment in medtech is huge. According to the WhatInvestment website the global medtech market is projected to will grow to $432.6bn by 2025, increasing at a compound annual growth rate (CAGR) of 4.1% for the next five years. The ongoing development of apps and smartphone interfaces will comprise a substantial part of that market, and their growth will doubtless be accelerated by the clear impact demonstrated by test and trace apps in Europe and elsewhere.
The importance of trust for medtech
With so much disinformation online about every aspect of the virus, maintaining trust in the UK test and trace app was vital. Throughout the project, one important challenge was unfounded public comments from privacy campaigners about the alleged potential for the app to infringe privacy.
In this case, what silenced many of the doubters was the release of the source code into the public domain. Every update to the app is published on the NHSX GitHub repository, which includes the documentation, the source code, the tests and the scripts that create the Amazon infrastructure that the app is hosted on. I have been contacted by leading privacy researchers who downloaded the source code and reviewed it: they congratulated us for upholding the privacy principles we set down; and this has defused much of the criticism.
When it comes to tackling distrust and rumour, the lesson for medtech is that transparency builds trust.
What about the near future?
There is so much potential for this trend to dramatically improve many treatments this decade alone. We should examine what kinds of medical devices could feasibly be recreated as an app.
- Companion apps for drug delivery devices, which dynamically configure prescription protocols or alert users on deviations from them
- Apps as diagnostic devices which could enable remote diagnostics and long-term monitoring of vital signs
- Apps which suggest health interventions to users or healthcare practitioners (HCPs), for example the self-isolation advice of the COVID-19 app
- Apps which assist in the remote interaction between patient and HCPs, such as the Babylon GP app
As an example of the first point, Medtronic is an insulin pump manufacturer in Great Britain. A smartphone app enabled them to develop an insulin pump small enough to be attached to the arm of the user. The pump regulates insulin release and can be controlled from the user’s phone.
My company’s own venture capital arm is investing in sensors which allow you to put your finger on your phone and have it measure all vital signs – including body temperature, pulse, respiration and blood pressure – with clinical precision.
Capabilities such as this will, for instance, enable pharmaceutical companies to drive down the cost of clinical trials: visiting a clinic each day to have your vitals monitored is expensive for the company and inconvenient for the participant. If the data can be gathered remotely, with the correct level of clinical accuracy, huge savings can be made.
Phone apps are also now being used in life-critical situations. For instance, there are thousands of parameters of a heart pacemaker’s function: if any of these aspects change, the patient must undergo surgery. To prevent this, pacemaker manufacturer Abbott has built a Bluetooth-enabled pacemaker defibrillator implant, for which it received market approval from the US Food and Drug Administration (FDA) last year. It now comes with a smartphone app which enables remote monitoring of the pacemaker, and the ability to digitally tailor the device with the app to the evolving needs of individual patients without their having to go through potentially unnecessary surgery.
The possibilities of medtech are numerous. Diagnoses can be faster and more accurate. Treatment and medication can be less invasive, less painful, and far more economic.
The impact that these medical device apps could have over the next five years can lead to earlier detection of health issues or better adherence to drug delivery regimen and, with that, improved quality of life. They can reduce the cost of healthcare considerably and enable healthcare in the developing world through remote diagnostics and consultation. In some instances – as was the case with the NHS COVID-19 app – they can save tens of thousands of lives.
Shaping the future
This year has demonstrated to us what is possible when public and political wills allow it. It is good to know that when the need arises, we are in a position to face up to a health crisis and find solutions at speed – but how much benefit might the medtech industries deliver to the world by carrying forward the lessons this crisis has taught us?
To get things done quickly, act like a start-up
To get the test and trace app developed quickly, we worked alongside the UK government’s Department of Health and Social Care (DHSC) to establish a working group that was allowed to operate like a tech start-up.
This made it much easier to respond quickly to the changing needs of the pandemic, and is in stark contrast to the DHSC’s usual role of overseeing the UK’s National Health Service – the biggest single employer in Europe, with 1.3 million employees.
People were pulled out of their silos – we had policy, user research, and development all working as part of the same team, using lean delivery techniques and cloud-based backend infrastructure to release new versions of the app via the Apple App and Google Play Stores weekly.