EDITOR’S NOTE: This article was published in the April 2018, Vol. 28, No. 1 issue of the journal Australasian Biotechnology under the title, “Top Five Medical Device Trends of 2018.” To download the article/issue, visit https://www.ausbiotech.org/news-room/publications.
The speed at which the medical device industry is changing and evolving is perhaps unrivaled in the life sciences industry. Medical device manufacturers are experiencing disruption from small companies and startups entering the market1, tech giants like Amazon are investigating and investing in medical device expertise and cybersecurity concerns are on the rise.
But despite uncertainty and challenges, the medical device industry continues to experience tremendous growth, potential and an abundance of opportunities for further technological innovation. Not only did Investing News predict that medical device manufacturers would capture major market share in 20172, but Evaluate Research estimates that by 2022, medical technology sales will exceed $530 billion. Sales rates for medical devices are expected to grow annually by 5.2 percent.
Taking this into consideration, we’ve identified five trends that industry professionals that are likely to have the most significant impact on medtech this year.
Tech behemoths Apple, Google and Amazon have turned their gaze to the life sciences sector and medical devices, but they’re not alone. Other business sectors are investing in bioelectric medicines (e.g., miniature implantable devices) to treat diseases while major courier companies are advancing into health care logistics, shipping and mobile health (mHealth) devices, such as smart device wearables.3
“Times are still good for medtech — but the health care industry as a whole is undergoing a period of significant change,” said Alexander Belcredi, an editor with Boston Consulting Group.4 “These changes could create a downward spiral for companies that cling tightly to business as usual. But those that build their capabilities and adapt their business models will find enormous opportunities to grow and thrive.”
Every year, pharmaceutical and medtech industries become more interdependent. In an environment which requires more device manufacturers to conduct clinical trials, many firms are looking to ally with pharmaceutical companies to minimize the resources needed to conduct clinical evaluations and navigate non-traditional registrations.
Conversely, pharma and biotech companies are seeking opportunities to partner with medtech firms to capitalize on the growing drug-device combination products market, estimated to exceed $115 billion by 2018.5 It’s expected that pharmaceutical manufacturers will continue to transition from blockbuster drugs to mHealth and wearable technology products to gain a competitive edge and add new revenue sources.
As consumers and industry stakeholders continue to demand better, safer products, government officials in the U.S., Europe and Australia have insisted upon improved regulatory oversight of the medical device industry. Many of the changes are a concern to medical device manufacturers because they are significant.
For example, in the U.S., ISO 13485: 2016 gives device makers until March 2019 to completely transition to a quality management system. Certification is voluntary in the U.S., but mandatory in several other countries, including Canada and Japan.
The Australian TGA have introduced a new guidance to prioritize the review designation for cutting-edge IVD technologies, considerably speeding up time-to-market. The TGA target for these novel IVDs is decisions on priority review designation applications that will take no more than 20 business days. This will help push technologies like AI and machine learning to the forefront.6
With baby-boomers entering their golden years, the market for interconnected medical devices is at an all-time high. It’s been fueled by devices such as Fitbits, smartphones, and now, smart speakers like Amazon’s Alexa-controlled Echo speaker, which has the potential to audibly remind a person to take her medications.
According to a 2017 report by the Australian Bureau of Statistics, the proportion of Australians aged 65 and over increased from 12.1 percent in 1997 to 15.4 percent in 2017.7 This population demographic is projected to increase more rapidly over the next decade as more baby boomers turn 65. Moreover, a report from the Parliament of Australia estimates that the country’s aged-care workforce will need to grow by 2 percent annually, “or triple its size for the next 30 years or so to meet demand.”8
Since many seniors won’t be able to afford an assisted living facility, tech-enabled homecare will be expected to fill the gap.
“Aging care is one of the most aggressive industries in innovation,” stated a report in the online trade publication TechRepublic.9 In the first half of 2017 alone, $3.5 billion was invested in 188 digital health companies, setting a record. 10
The potential market for bioelectronics and internet-connected devices is significant, but the level of their success may depend on two critical issues — security and data privacy.
“Things are coming to the market very, very fast, and a lot of these organizations that are building these devices are trying to be first on the market,” said John Petersen, senior manager with The Chartis Group.11 “That’s a huge risk to any organization, as that’s a starting point for really any type of breach into the network.”
Australia’s Emergency Care Research Institute (ECRI) has listed ransomware and other cybersecurity threats to healthcare delivery among its top 10 health technology hazards for 2018 that can endanger patients.12
According to a poll report from PwC HRI, 50 percent of respondents said they would avoid using a connected medical device in the wake of a cyber breach.13 And Info Security Group reported in August 2017 that more than one-third of surveyed medical device manufacturers said that their organizations experienced a cybersecurity incident in the past year.14
So, while these trends to the medical device manufacturing industry could be viewed as potential challenges, it is important to remember that the industry is evolving quickly and adapting to meet these obstacles. Many of these “obstacles” also present promising opportunities to expand medtech into new sectors into and well beyond 2018. The key for manufacturers is to remain nimble, adaptive and to implement policies, practices and course corrections to navigate the fluidity within the industry.
(1) “Top 10 Crucial Medical Device Trends for 2018,” by Lauren Gerard. BizVibe Blog, Dec. 18, 2017. https://www.bizvibe.com/blog/top-10-medical-device-trends-2018/
(2) “Top Medical Device Trends for 2017,” by Chelsea Pratt. Investing News.com, Jan. 4, 2017. http://investingnews.com/daily/life-science-investing/medical-device-investing/top-medical-device-trends/
(3) “Google Patents a Wearable that Tells You to Take Your Medications When You Eat,” by Novet, Jordan Novet. Jan. 9, 2016. http://venturebeat.com/2016/01/09/google-patents-a-wearable-that-tells-you-to-take-your-medications-when-you-eat/
(4) “Medtech Companies Need to Transform While Times are Still Good,” by Alexander Beldredi, et al. The Boston Consulting Group, July 16, 2016. https://www.bcg.com/en-us/publications/2016/medical-devices-technology-transformation-medtech-companies-need-to-transform-while-times-are-still-good.aspx
(5) From press released issue by Transparency Market Research on Jan. 20, 2016. http://www.transparencymarketresearch.com/pressrelease/drug-device-combination.htm
(6) “Priority review designations medical devices (including IVDs); Version 1.1, Feb. 2018.” Department of Health Therapeutic Goods Administration. Feb. 13, 2018. https://www.tga.gov.au/book/export/html/769683
(7) Australian Bureau of Statistics’ Australian Demographic Statistics, June quarter 2017. http://www.abs.gov.au/ausstats/abs@.nsf/0/1CD2B1952AFC5E7ACA257298000F2E76?OpenDocument
(8) “Future of Australia’s aged care sector workforce,” by the Parliament of Australia (APH). https://www.aph.gov.au/.../AgedCareWorkforce45/.../AgedCareWorkforce45/c02.pdf
(9) “How Tech Can Help Seniors ‘Age in Place,’ Save Money and Be Independent,” by Hope Reese. TechRepublic.com, Oct. 10, 2016, http://www.techrepublic.com/article/how-technology-can-help-the-aging-populationhow-tech-can-help-the-elderlyage-in-place-save-money/
(10) “Digital Health Funding 2017 Midyear Review: A record breaking first half,” by Halle Tecco and Megan Zweig. https://rockhealth.com/reports/2017-midyear-funding-review-a-record-breaking-first-half/
(11) “Medical Devices Safety Update, Volume 6, Number 1, Jan. 2018” Department of Health Therapeutic Goods Administration. Jan. 15, 2018. https://www.tga.gov.au/publication-issue/medical-devices-safety-update-volume-6-number-1-january-2018#fn1
(12) “Top Ten Tech Trends in 2017: Medical Devices are the New Cyber Threat Landscape,” by Heather Landi, March 23, 2017. https://www.healthcare-informatics.com/article/cybersecurity/top-ten-tech-trends-2017-medical-devices-are-new-threat-landscape-0
(13) 6 “Medtech’s Take on Washington Policies,” by M. Thibault. mddionline.com Jan. 17, 2017, http://www.mddionline.com/blog/devicetalk/medtech-take-washington-policies-01-17-17
(14) “Medical Devices in the Crosshairs with 36 % of Orgs Attacked,” by Tara Seals. InfoSecurity Magazine, Aug. 15, 2017. https://www.infosecurity-magazine.com/news/medical-devices-in-the-crosshairs/
Terry Walsh has more than 20 years of experience in life sciences manufacturing, IT and quality engineering sectors in a variety of roles, including engineer, owner, partner, principal consultant and business development manager. He is thrilled to serve as director of APAC with MasterControl due to his passion for helping professionals achieve the highest levels of quality and productivity using state-of-the-art technology and training.
Previously, Walsh served as a regional account executive for Australia and New Zealand with MasterControl, and prior to that was a principal quality engineering and GMP consultant with CVP Quality Systems. He’s served in a diversity of capacities and roles with SeerPharma, EC Integrators, CSL, and Pfizer. Walsh holds a master’s degree in pharmaceutical manufacturing and a bachelor’s degree in manufacturing/mechanical engineering from the Institute of Technology, Dublin, Ireland.