This year our annual look at the medical device trends is, as in every other sphere of business, heavily dominated by the impact of COVID 19. In January 2020, before the pandemic, we identified six key trends for Medtech: more Diagnostic Tools and Personalised Medicine; convergence of AI and Digital Health Technologies; focus on Cybersecurity for the Internet of Medical Things (IoMT); new Surgical Procedures and an increasing use of Robots; and Drug Delivery expanding with a focus on Reusable Devices. However, barely two months into the year, the emerging pandemic forced us to revisit our predictions and ask ‘How will Coronavirus impact Medical Device Industries?’.
This highlighted the following key effects:
As the year has progressed, these trends have all played out, largely as predicted. As we look forward to 2021 and hopefully to life after COVID, we consider what other long-term effects the pandemic will have on the world of healthcare and medtech. Considering the effects of the pandemic together with longer term trends in medical device technology we have identified seven key themes for 2021.
In a bid to track and control the virus, governments around the world have one of the main drivers of innovation in the area of diagnostics. In its most basic form this has involved the large-scale purchase of diagnostic test equipment, reagents and test kits but governments have also stepped into the device innovation area by providing grants for innovative technologies related to the diagnosis and treatment of COVID 19. By May of 2020 the European Commission had approved €117 million of grants for Medtech projects related to Covid 19. This is likely to continue as governments seek to find solutions for some of the problems faced by their health services.
Equally significant has been the rapid approval of new and innovative tests and therapies. In the USA, the FDA issued an increased number of Emergency Use Authorisations (EUAs) for new devices and modifications and EU regulators. According to research company Globaldata, there are more than 140 Point of Care (POC) COVID diagnostic test kits in development. Early leaders include US Biotech firm, Lucira Health, which received an EUA for its COVID-19 home test kit in November, and UK biotech company Genedrive, who notified the FDA of its intent to distribute its Genedrive 96 portable PCR machine with SARS-CoV test kits in the USA.
In the coming years it is likely that many of the systems being used for detecting coronavirus will be adapted and repurposed for the detection of other protein and genetic markers, leading to an expansion in rapid and cheap diagnosis of other conditions, including cancers.
2020 saw a massive uptake in telehealth and remote as the pandemic created a requirement to minimize clinic and hospital visits whilst still trying to maintain a continued and high standard of care. According to a 2020 report by McKinsey, use of telehealth services by US healthcare consumers went from 10% in 2019 to 50% in 2020. This is likely to continue beyond the pandemic as healthcare providers come under increasing pressure to reduce costs without compromising care outcomes. Consumers seem happy with the change, with 83% of consumers in a Globaldata survey considering telemedicine as an established element of healthcare.
Whilst much of this rapid expansion has taken the form of telephone or online consultations, the continued development of connected devices, is seeing an increasing number of patients using devices which feed the results back to their healthcare providers to interpret. Areas include vital signs monitoring, drug regime compliance and insulin and diabetes monitoring, amongst others. As the quantity of data generated by such devices increases, so will the use of automated algorithms and AI. The growing prevalence of connected devices and the ever increasing amount of personal health data being collected will ensure the focus on cyber security will only increase as predicted in our report last year.
As well as dedicated medical device wearables, consumer-based wearables such as the Apple Watch and Fitbit fitness trackers are also being increasingly used in health monitoring. The current Apple Watch series 6 features a blood oxygen monitor although not registered as a medical device, it is clear that these devices have every capability to measure such health indicators. Last year saw a study with Fitbit wearables detecting 50% of coronavirus infections a day before symptoms were reported and Whoop wearables being used to monitor patients participating in phase III trials of the Sinopharm COVID-19 vaccine, reducing cost and contact required to monitor trial participants.
Looking forward across the next few years, it is clear that consumer wearables are increasingly going to enter the medical sphere. Improved availability and functionality will see an increased use of wearables to encourage active lifestyles and prevent illness, with companies such as UK health insurance provider Vitality Health providing an Apple Watch and dedicated tracking app to policy holders. With FDA guidance on Software as a Medical Device (SaMD) and EU MDR regulations, more consumer wearables are likely to be classified as medical devices.
While coronavirus has put healthcare into the spotlight, many areas of medtech have been negatively impacted. Surgeries have been dramatically reduced with orthopedics, particularly badly hit. Away from COVID, clinical trials and uptake of innovative technologies have been delayed or cancelled, and in many cases investment capital has been held up or diverted to COVID related technologies. The growth of robotic surgery stalled with Intuitive, the US manufacturers of the Da Vinci robotic surgery system, reporting a 3% reduction in earnings for 2020.
With the rollout of the vaccine these elective surgeries and clinical trials will restart, but with COVID unlikely to disappear completely, some healthcare capacity and funding will inevitably be diverted to COVID diagnosis and treatment. Therefore, procedures are unlikely to return to pre-pandemic levels before 2022 at the earliest. This is likely to cause some consolidation as companies with stronger balance sheets look to competitors struggling from this slowdown.
The global shortage of PPE and ICU equipment at the beginning of the pandemic highlighted the fragility of some global supply chains and inventory systems. With global freight prices increasing by up to 300%, many companies have begun the process of reassessing those supply chains and reshoring or multi-sourcing parts of the production. For the development of new devices, a greater proportion of the devices are likely to be made closer to the final market and expect to see investment in greater clean room and high-tech manufacturing in US and Europe.
With the introduction in the EU of the Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) from May 2021 and May 2022 respectively, the approval process for getting a medical device CE mark has in many cases become more onerous than for obtaining FDA approval. Previously, a common strategy for Medtech companies would be to first gain CE under the MDD and then later apply for FDA clearance. This strategy is likely to now be reversed with many companies applying in parallel or initially in the US.
Alongside this, the UK’s Exit from the EU will see it diverge from CE regulations as it will maintain the previous, less stringent regulations. Although many companies are likely to follow the EU practice, it is likely that the UK will be chosen by startups and innovators looking to trial new devices and technologies and obtain more rapid market access.
Whilst being the first country to face the coronavirus pandemic, China’s tough, rapidly imposed, lockdown allowed it to return to near normality within a few months. Global demand for PPE and medical consumables has boosted manufacturers and led to a resurgence in the economy across all sectors but with medical technology companies performing very well. This, coupled with government led efforts to reduce China’s reliance on imported innovation, has led to a boom in the home-grown development of medical device innovations. With increased healthcare spending and a growing economy, we see this as the beginning of a period of strong growth for the Chinese medtech sector.
Whilst 2020 saw some disruption for some of IDC’s clients in UK and Europe, most of our developments continued. The 2020 launch of the IDC-designed ShailyPen Axiom and Protean, disposable and reusable injection pens, will be followed in 2021 with the ShailyPen Harmony Platform, as well and development of autoinjectors and wearable pumps.
The expansion of our electronics and software teams will see more connected device projects as well as the development of innovative wearable technologies and the automation of innovative laboratory testing and diagnosis systems.
IDC’s partnerships in China will see innovations heading in both directions as innovative Chinese companies look to go global and IDC assists medtech SMEs to gain product approvals and partner with large scale Chinese distributors.