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Jul 20, 2017

5 Trends Driving Disruption in the Med Device Industry in 2017

Connected devices for seniors
may allow them to age in place.




by Lisa Weeks

MasterControl Staff Writer


The medical device industry is complex, ever-changing and highly regulated, that much we know. We also know that, despite the complexity, the outlook is rosy for device manufacturers that can recognize—and navigate—the major trends of the day. The purpose of this post is twofold: to identify the trends that are likely to have significant impact on the industry this year, and to provide some high-level tips for exploiting them. Here's a mid-year review of 2017's biggest trends---and some tips for exploiting them.



#1 Other Business Sectors Will Continue to Disrupt the Space


Google and Apple may have led the charge, but we can expect to see other business sectors vying for a piece of the health care market in 2017. “As emerging technologies are further integrated into health care, more tech and non-traditional device companies will continue to enter the space,” according to Matt Lowe, an engineer who has successfully launched more than a dozen medical devices and serves as executive vice president of MasterControl. “To stay competitive, established players will have to gain knowledge of these new technologies, or partner with companies that already have it.” 

 
Lowe cited the growing sector of bioelectronics as an example. Bioelectronic medicines are miniaturized, implantable devices—smaller than grains of rice—that deliver small doses of electricity to the body’s nervous system. One day, these tiny devices could be used to treat a wide variety of diverse disorders, such as asthma and diabetes, better and with fewer side effects than conventional drug therapy.1

GlaxoSmithKline, one of the world’s largest drug manufacturers, is making great strides in the budding bioelectronics sector since partnering with Verily, the life sciences arm of Alphabet, Google’s parent company, last year. Their joint venture, Galvani Bioelectronics, combines GlaxoSmithKline’s drug development expertise with Verily’s engineering know-how to pioneer a new technology that could improve millions of lives.2


#2 The Marriage of Pharma and Med Device


The alliance between Verily and GlaxoSmithKline is indicative of a larger trend, according to Alex Butler, the director of medical device industry solutions at MasterControl.
“No question about it, the pharmaceutical industry is becoming more dependent on medtech—and vice versa,” he said.


As more device manufacturers are required to conduct clinical trials on their devices, many are looking to partner with pharmaceutical companies to leverage their experience running complex clinical evaluations and navigating non-traditional registrations.

On the flip side, pharmaceutical companies want to partner with device companies to take advantage of the growing drug-device combination products market, which is expected to reach $115 billion by 2019, per Transparency Market Research (TMR). 


#3 Connected Devices for Seniors Are Becoming More Popular   


The availability of interconnected devices, e.g., Fitbits, smartphones and Amazon’s Alexa-controlled Echo speaker, present a tremendous opportunity for the health care industry. One aspect of the Internet of Things (IoT) that hasn’t received much public attention (until now) is how networked devices might support older adults in aging independently at home—and bridge the growing care gap for baby boomers.

The AARP Public Policy Institute predicts that the supply of caregivers is unlikely to keep pace as baby boomers move into old age. In 2010, the caregiver support ratio was seven potential caregivers for each person aged 80 or older. The ratio is expected to fall to four to one by 2030 and three to one by 2050.4
  
“Many seniors simply don’t have the funds to cover moving to an assisted living facility,” said Butler. “Tech-assisted homecare will allow seniors to monitor and track their homecare through mobile devices and age in place.”


While the growing demand from seniors for connected products is exciting, there are some caveats. “Compliance is a big issue, as is the user's ability to manage the data,” said Butler. “Companies must implement robust design and validation controls into their devices to account for these human factors.”   


#4 Continued Issues with Cybersecurity Will Threaten Innovation


Lowe thinks the potential of bioelectronics and internet-connected devices hinges on security and data privacy. “As devices become more interoperable, they also become more vulnerable,” he said. “Device makers must be able to assure consumers that their devices are safe from hackers, or these new products and technologies will not gain market acceptance.”

A report from PwC HRI seems to confirm Lowe’s predictions. Fifty percent of respondents said they would avoid using a connected medical device in the wake of a cyber breach.5 
Unfortunately, in 2016, the device industry had its share of cybersecurity scandals—Johnson & Johnson being the biggest. In September, the company had to warn customers of a cybersecurity vulnerability found in its Animas OneTouch Ping Insulin pump, making them the first major medical device manufacturer to address hacking threats. After consulting with the FDA, the company sent letters to 114,000 U.S. patients explaining the issue, and how to resolve it.

Historically, device manufacturers have been reluctant to reveal threat and vulnerability information due to confidentiality issues. Butler said they might not have a choice; consumers are demanding it.



This article is an excerpt from the White Paper:
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#5 The Trump Administration Will Shake Up the Industry


Spoiler alert! Many government programs introduced during the Obama administration will be significantly impacted by the 2016 presidential election results and, in turn, will impact device makers.

While the Affordable Care Act was not repealed, device executives are hoping the highly controversial 2.3% medical device excise tax will be. The tax has been on temporary suspension since December of 2015, but industry groups like AdvaMed are pushing for a full repeal. If this happens, Lowe said it will be a huge boon to device manufacturers and innovation.



A survey recently conducted by the Medical Device Manufacturer Associations revealed that 75% of device executives would invest more money in jobs and research and development if the tax was eliminated.6

What other trends do you expect to see in 2017? What do you consider to be your biggest challenges this year, and how are you planning to address them? Please leave a comment, and don’t forget to download the full white paper.


Lisa Weeks writes extensively about technology, the life sciences and other regulated environments. In addition to GxP Lifeline, her work has appeared in numerous industry publications, including Medical Product Manufacturing NEWS (MPMN), Medtech Pulse, Risk Insights, MD+DI, Medical Product Outsourcing (MPO), Medical Design Technology, Pharmaceutical Processing, Genetic Engineering & Biotechnology News (GEN) and PharmaTech.



References 
1 GlaxoSmithKline website, viewed March 30, 2017,

2 ‟GlaxoSmithKline and Google’s Verity to Invest £540m in joint UK Research Centre,” by Julie Bradshaw. The Telegraph.com, August 1, 2016,

3 From press released issue by Transparency Market Research on January 20, 2016,

4 “The Aging of the Baby Boom and the Growing Care Gap: A Look at the Future Declines in the Availability of Family Caregivers,” by Donald Redfoot, Lynn Feinberg and Ari Houser. AARP.org, viewed on April 31, 2017,

5 “Top Medical Device Trends for 2016,” by Morag McGreevey. Investing News.com, viewed on March 1, 2017,

6 “Medtech’s Take on Washington Policies,” by M. Thibault. mddionline.com January 17, 2017,

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