man wearing VR headset medical device

MedTech 2021: What the future holds for the medical devices industry

Despite a short-term downturn caused by COVID-19 disruption, the sector’s resilience and emerging cultural importance will see its value continue to soar in the coming years.

 

The initial economic shock of COVID presented an opportunity for medical device companies. For many industry insiders, the main impact of the pandemic on the medtech sector has been the acceleration of trends that were already well underway in the preceding years. 

 

Rapid advancements in AI technology, device connectivity, remote monitoring, and data collection have enabled medtech companies to adequately respond to the demand for critical products such as personal protective equipment (PPE) and ventilators. By being able to quickly scale up R&D and manufacturing efforts, the sector has played a central role in easing the pressure on overstretched healthcare systems. 

 

Opportunity amid disruption

In many ways, COVID-19 changed everything for the medical device market. 

 

After three straight years of record investment, the pandemic hit the sector’s coffers hard. The first half of 2020 saw U.S. revenues decline by 5%, venture capital funding in the sector dropped by 22%, and the total value of non-megadeals fell 44% (EY).

 

However, the external events of the pandemic have caused a wholesale shift towards business models that allow medtech organisations to properly capitalise on existing trends within the sector. As reported by EY:

 

“The rise of connected devices is drawing medtech into the Internet of Things and opening up new opportunities for data-driven improvements in clinical outcomes; growing cost constraints on health care systems; establishing the impetus for providers to assist medtech in reshaping its business models and ecosystem relationships; and seeing patient-consumers’ increasing demands for a more customer-centred health care experience. These drivers of change were all recognised by the medtech industry prior to 2020.”

 

Thanks to these long-term trends, the industry has met the demand for specialist equipment and remained resilient in the face of adversity. Indeed, despite some segments receiving financial blows, other segments such as diagnostics have surged in value and become a major target for investment. And though revenue for the medical device industry has been falling since the start of the pandemic, the sector is expected to slowly recover in the second half of 2021. 

 

The rise of “anytime, anywhere” healthcare

The logistical constraints placed on physicians and patients alike have also necessitated a rise in the use of wearable medical devices and virtual technologies — a trend that will no doubt accelerate further throughout the 2020s. 

 

While the trend of remote care was already in full swing in the 2010s, COVID has taken it to the next level. According to EY, 95% of physicians have increased their use of virtual technology since the start of the pandemic. Before COVID, 80% did not use it to interact with patients.

 

By integrating medical devices into the Internet of Things (IoT), medtech organisations and regulatory bodies are working more closely with each other (as well as with healthcare providers) to drive better patient outcomes at lower costs. In an increasingly complex health ecosystem, collaboration is becoming a hallmark of the industry.

 

In this article, we’ll look at how the key driving forces that have defined the medical device industry during the last half-decade will continue to influence the market in the 2020s — particularly in the immediate post-COVID recovery period.

 

Evolving business models

As COVID has shown, unprecedented disruption can strike at any time. With the direct impact of COVID expected to endure for at least three to five years, businesses need to ensure they meet growing demand while keeping their operations cost-efficient and scalable. 

 

EY has outlined four future business model approaches that medtech companies can adopt to “futureproof organisations and to enable effective deployment of limited capital resources.” They are:

 

  1. Breakthrough innovator. Companies that adopt this model develop products and services that carry high prices. They are typically paid for by traditional health insurance. Such innovative technologies include Intuitive Surgical’s famous da Vinci platform.
  2. Disease manager. These are personalised solutions that help end-users manage chronic conditions in a bespoke way. The focus is on user experience, convenience, and maximum adherence. Examples include Echo Pharmacy’s medication order app.
  3. Lifestyle manager. These companies develop products that are aimed at maintaining overall health and wellbeing, as well as encouraging behaviours that can help to prevent disease. Their products are marketed directly to the consumer. Examples include wearables such as the Apple Watch as well as Fitbit's smartwatches and trackers.
  4. Efficient producer. These companies are the developers or providers of high-volume, low-cost commodity products. Such products include protective personal equipment (PPE) and ventilators. 

COVID-19 demonstrated the short-term resilience of each of these business models and their importance within the medtech ecosystem. In the longer term, medtech companies will need to be proactive and choose business models that secure the most value and help futureproof operations.

 

Supply chains

As healthcare becomes more virtualised and moves towards an “anytime, anywhere” model, medtech companies need to ensure their supply chains are ready to meet this change. However, a number of challenges stand in the way.

 

Pre-COVID, the industry faced the problems of inefficiencies associated with supply intermediaries and inflexible legacy systems, as well as a lack of transparency for regulators and companies alike. These were already hotly-contested topics prior to the pandemic.

 

Arguably the biggest challenges, however, are political in nature. The last decade has seen a widespread backlash against globalisation (and, by association, against globalised supply chains) from nationalist politicians and their support bases. COVID has made travel restrictions a reality, but so too have seismic political events such as Brexit. 

 

Changes to trade agreements have far-reaching implications for the industry, most notably around the location of manufacturing plants, which are typically concentrated in low-cost geographies. Will such restrictions lead to the “onshoring” of manufacturing to safeguard supply bases? Only time will tell.

 

Thus far, the medtech sector has not sought to localise supply. Instead, it has responded to supply chain disruption by forging mutual partnerships between device manufacturers and component part manufacturers. 

 

In May 2020, for example, the medtech trade association AdvaMed launched the VentConnect platform to link device manufacturers with component suppliers. In August, the platform rebranded as Med Device Network — its scope expanded to cover devices beyond the pandemic.

 

Regulation

COVID-19 has transformed regulation in the medtech sector. Since February 2020, the FDA has authorised over 250 emergency use authorisations (EUAs), while the EU chose to defer its Medical Device Regulation (initially slated for May 2020) by a year. These moves are symptomatic of a wider industry trend that has seen the loosening of stringent regulatory conventions across the globe.

 

Of course, this relative leniency was borne out of the need to quickly and effectively get new devices to market as part of the fightback against COVID. As the virus retreats, the frequency of EUAs will likely decrease. But a precedent has been set. 

 

During the pandemic, regulators and medtech organisations have been receptive to one another and come together to meet the urgent demand for vital equipment (including in vitro diagnostics and other tests, as well as PPE and ventilators). Beyond COVID, this sense of collaboration and collaboration is set to flourish further.

 

The Internet of Things (IoT) in healthcare

The advancement of technologies such as smart sensors and smart devices is increasingly bringing medical devices that capture data into existing care pathways via the Internet of Things (IoT): the giant system of interconnected, Internet-based devices that collect and transfer vast amounts of data across a wireless network. 

 

By aiding with the monitoring and diagnosis of disease, this integration of medtech platforms is improving patient outcomes, lowering costs, and improving end-to-end efficiency.

 

Most notably, IoT-enabled devices are ushering in an era of preventative care. With most of these devices being wearable and connected to smartphone apps, users are given greater autonomy over their health and wellbeing — and presented with accurate data from which they can make better-informed decisions about their treatment.

 

For medical device companies, the expansion of device connectivity also presents an opportunity to provide a value-based service — according to a Research2Guidance survey (commissioned by Deloitte), 31% of medtech organisations were already offering data distribution channels as a service in 2018.

 

As the 2020s progress, further IoT integration between all parties in the medtech ecosystem will take place — providing value for patients and new opportunities for business. By 2029, the Internet of Medical Things (IoMT) market is forecast to grow $285.5bn (£204.9bn) — with CAGR of 28%.

 

Software as a Medical Device (SaMD)

Defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device,” SaMD is having a huge impact on healthcare.

 

This technology enables patients living with chronic conditions to capture data and, if willing, share it with their health professionals. By opening up new digital pathways for screening, diagnosis, monitoring, and alerting, SaMD empowers people to become active agents in their healthcare plans. And with the technology becoming cheaper, more powerful, and more accessible, SaMD gives physicians the data and scope to develop personalised treatment plans.

 

According to a Deloitte survey, just under half of patients are willing to share their personal data for medical research. That said, protecting patient privacy is paramount, so we can expect to see further regulation passed aimed at ensuring confidentiality and patient control over their data.

 

Robotics technology

Over the last five years, major advances in robotics technology have led to a huge spike in demand for minimally invasive robotic surgery (MIRS), causing the surgical robot market to experience double-digit growth. 

 

This trendline is set to continue its upward trajectory. By 2025, the number of global MIRS procedures will more than double to 2 million, while the market is predicted to grow from $5.5bn (£3.95bn) to over $24bn (£17.26bn)

 

The COVID pandemic has caused an upsurge in the use of robotics in a hospital setting. With medical services being restricted and unprecedented demand being placed on hospitals, robots have proven an efficient, cost-effective method to provide safe and socially-distanced preoperative, intraoperative, and postoperative care. 

 

According to a 2020 study by Zemmar, Lozano & Nelson, this rise in robotics “may well outlast the pandemic and revolutionise surgical performance and management.” With demand for MIRS only increasing, the medtech sector will look for innovative new ways to create surgical robots that are more accurate, dependable, and easy to use.

 

Cybersecurity for medical devices

One downside in the advancement of smart medical device technology is the threat of increasingly sophisticated cyberattacks.

As the number of medical devices that are integrated with clinical cloud applications increases, so too does the possibility that hackers may gain unauthorised access to data and cause potentially adverse side effects to the patient. Securing patient privacy and safety, then, is of the utmost importance to medtech companies.

 

Though there have not been any documented cyberattacks on medical devices so far, a raft of regulation has been passed to safeguard against the looming menace. In June 2019, for example, the European Union ratified the Cybersecurity Act, which requires manufacturers to set IT security measures for medical devices and protect against unauthorised access.

 

The FDA holds manufacturers primarily responsible for managing cybersecurity risk in their products. Moving forward, companies need to act quickly and collaboratively to mitigate cybersecurity risk. 

 

The future outlook: an overview

Ongoing advancements in medical technology and the growth of information sharing through IoT-enabled devices are causing a sea change in healthcare. 

 

Just as changes to working patterns and consumer behaviours have facilitated the need for remote technologies, so too has the evolution of the relationship between patients and physicians. As the COVID-19 pandemic demonstrated, the medical device market is more than ready to meet this demand for user-friendly diagnostics and monitoring devices.

 

The key challenge for the sector is how to best use data to optimise patient outcomes while also safeguarding patient privacy. The success of this goal depends on medical device companies and regulators coming together to build infrastructure with agreed-upon expectations and boundaries. 

 

Governments have a major role to play, too. The U.K. government, for example, has launched incentives (such as waiving VAT and import duties on vital medical equipment) to buffer the nation’s medical device industry during the pandemic. Beyond COVID, the U.K. aims to become a leader in medical device technology and has pledged to pump tens of billions into the sector in the coming years.

 

The global medical devices industry expected to reach a valuation of $612.7bn (£440.5bn) by 2025, growing at 5.4% CAGR. Thanks to growing consumer demand and technological innovation, we can expect to see high growth in product areas such as wearable healthtech, robotics nanotechnology, and extended reality devices. Artificial intelligence is also facilitating the creation of increasingly sophisticated data-driven algorithms, such as autonomous diagnostics.

Despite recent setbacks, opportunities abound for medical device companies of all sizes.

 

To mirror the convergence of the medical and technology industries, SRG and our sister brand Lorien have partnered to provide a one-touch service for clients at the intersection of their expertise. If you’d like to find out more, or discuss the wider trends at the heart of the medical device sector and how they could affect your business, you can speak to one of our industry experts here >

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