The smart medical devices industry has exploded in recent years, and with technology developing at a breakneck pace, its influence is set to soar.
The Fourth Industrial Revolution is gathering steam, and smart medical devices are at the forefront of this charge. Interconnected and integrated with other commercial smart devices, ongoing technological advancements mean that smart medical devices are poised to drive a sea change in how we diagnose and treat diseases in the next decade.
In fact, some say that the smart medical device revolution has already arrived. As Business Insider recently pointed out, medical devices such as FItBits and wearable blood pressure monitors are now part of the cultural zeitgeist; a familiar sight on the wrists of people all over the world.
So what, then, does the future hold for an industry that’s currently worth hundreds of billions of dollars and growing at a rapid rate? In this overview, we look at the implications that the ongoing growth of the smart medical device market will have on global healthcare delivery.
How portable and wearable devices are revolutionising healthcare
What do we mean by smart medical devices? Broadly speaking, the term refers to medical devices that have been rendered portable or wearable thanks to advances in miniaturisation and wireless connectivity. These devices can encompass a range of product types, from activity monitors and smartwatches to wearable patches and smart clothing.
With a slew of key players entering the fray — including industrial manufacturing giants like Siemens, pharmaceutical big spenders like Hoffmann-La Roche, and a number of medical device startups — these devices are serving an ever-expanding range of vital uses in healthcare. Whether used in diagnostic and monitoring, therapeutic treatment, injury prevention or rehabilitation, smart medical devices can be life-changing, and, in many instances, life-saving.
Devices such as continuous glucose monitors (CGMs), for example, provide invaluable data that offers insight into diabetic symptoms and epidemiological trends, enable healthcare providers to monitor patients in real-time, and generally give people with diabetes more control over their quality of life and treatment.
By optimising the patient-doctor interaction, such devices incentivise patient adherence — reducing hospital readmissions caused by poorly managed health, freeing up time for health professionals and saving the healthcare industry money. Moreover, the growing datasets gathered from these devices facilitate further advances in burgeoning fields of healthcare such as personalised medicine and gene therapy.
Key challenges to overcome
According to the cardiologist Eric Topol, author of Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again (2019), the starting point for the development of smart medical devices was the introduction of smartphones — specifically, the launch of the iPhone in 2007. Considering that this was only 12 years ago, it’s unsurprising that the computational power of these devices and the speed at which they have developed is disconcerting to many.
Indeed, as the 2018 Netflix documentary, The Bleeding Edge explores, the fast-growing nature of the smart medical device market and the venture capital rush to innovate can lead to “devastating consequences for patients.” According to critics, devices that pass the US Food and Drug Administration (FDA) 510(k) clearance process are not properly vetted in clinical trials, and devices can often malfunction. This supposed lack of stringent regulation, particularly in the US market, was featured on Last Week Tonight with John Oliver in June 2019.
On a more positive note, Topol’s aforementioned book makes the case for further applications of AI in medicine fostering big improvements in both healthcare delivery and cost.
The global smart medical devices market size
According to a report by Fortune Business Insights, the global medical devices market was worth US$ 425.5bn in 2018. By 2025, the market is expected to reach US$ 612.7bn, with a compound annual growth rate (CAGR) of 5.4%.
Interestingly, various medical devices market reports indicate that the growth of the market in emerging nations is outpacing growth in developed nations. In 2018, the North American market was valued at US$ 169.3bn (40% of the global market share). While this region is expected to hold a significant share of the market in the forecasted period up to 2025, growth in the emerging Asia-Pacific region is anticipated to be faster due to increasing per capita income, an ageing population, more widespread disease awareness and improving health infrastructure.
Some future trends to look out for in the smart medical device industry
1) The outsourcing of R&D to smaller businesses
With the emergence of disruptive new players, personalised technologies, and constantly evolving regulatory requirements, various medical device manufacturers that deploy traditional R&D strategies are finding their methods ineffectual in retaining a competitive advantage.
In response, many businesses are increasingly outsourcing their R&D efforts to organisations outside the industry that specialise in value-driven product development. Calling on outside help in R&D (and thus gaining access to advanced technologies) can minimise risk, reduce time to market and ensure quality innovation. Outsourcing can prove especially beneficial to medical device startups, who may lack the funding or expertise to safely develop a product from ideation to commercialisation.
According to Steve Maylish, chief commercial officer of Fusion Biotec Inc., “Today there’s a push to save money and provide value in healthcare, but it’s difficult to provide that value by iterating existing designs. Looking for outside expertise makes so much more sense now, because there is so much more technology.”
The global medical device outsourcing market alone is expected to be worth US$ 193.6bn by 2025.
2) Effective partnerships between tech giants and digital health players
"Partnerships in the health continuum bring together an ecosystem of players who can contribute to a final healthcare solution for customers."
— Maaike van Velzen, head of IP portfolio management at Philips
With a long-standing culture that emphasises innovation and speed, big tech companies like Google, Amazon and Apple are increasingly making inroads into the “digital health market.” Such an approach is often at odds with the rigorous development process needed in the medtech industry, however. Aside from Apple, the big tech giants have often found it difficult to translate product ideation into successful medical devices.
The solution? Medical device manufacturers such as Dexcom are teaming up with tech companies to meet the growing demand for smart devices, optimise the R&D process and improve healthcare delivery. According to a new Deloitte study, the medical device market of the future will be characterised by the convergence of health and consumer tech.
Indeed, initiatives such as Google Cloud’s much-publicised partnership with Flex, a Healthcare Information & Management Systems Society (HIMSS) manufacturer, appear to herald a more collaborative marketplace.
However, with some voicing concern that the intervention of the big tech players may saturate the industry (hundreds of new patents are being filed as we speak), medical device companies will need to ensure that they do not infringe on patents from other industries when incorporating tech-based innovations to their products.
3) More stringent regulation
In response to the ethical concerns related to the 510(k) FDA clearance process, medical device manufacturers and their partners are increasingly implementing processes to ensure they meet global compliance standards — particularly in regions that do not have regulations as strict as those in the EU.
Medical-grade Internet of Things (IoT) platforms such as Flex’s BrightInsight, for example, enable companies to securely manage and analyse data from various medical devices within a regulatory-compliant environment. BrightInsight recently raised $25 million to enhance its regulated platform and “accelerate global commercialisation”, demonstrating the industry’s commitment to integrate products to a regulated global healthcare ecosystem.
As we enter the 2020s, global demand for emergent technologies such as AI, blockchain and advanced analytics is poised to skyrocket. With health challenges such as an ongoing rise in chronic diseases and an ageing population in the developed world, as well as malaria, tuberculosis, HIV/AIDS and non-communicable diseases (such as malnutrition) in developing countries, it’s not difficult to see why.
It’s important for market players to remain vigilant, however. Disruptive new startups will emerge to take a share of the pie, and further innovation will propel the wider healthcare industry into unprecedented territory.
As criticisms of the 510(k) FDA clearance process have demonstrated, new technologies can often bring unknown risks to users. However, with the latest trends in the smart medical device market geared towards increased collaboration and greater safety measures, the outlook is a promising one.
Though it’s too early to predict the full impact they will have on society, smart medical devices are set to revolutionise patient care for the better.
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