After the mega-merger era of 2015-2016, the passage of the 21st Century Cures Act and a new administration in the White House, many in the medical device industry are wondering what changes are on the horizon for 2017.
It’s unclear whether the U.S. Food and Drug Administration (FDA) or the market will be the biggest driver of change, or exactly how these elements will affect the industry.
In this post, we’ll look at some of the most important medical device trends to watch this year.
- Regulatory Changes
What will the new Trump administration mean for medical device regulations? Many companies are watching key areas such as:
- Affordable Care Act (ACA): The medical device industry is obviously looking for a repeal of the medical device tax. And while some industry groups are promoting repeal of ACA as a whole, there are concerns over how loss of coverage for millions might disrupt the market.
- Medical Device User Fee Agreements (MDUFA): The FDA’s current Medical Device User Fee Agreements require medical device manufacturers to pay over $200,000 for a new device. The industry is looking to reduce these fees (or at least prevent an increase), and MDUFA negotiations could provide a barometer on the incoming administration’s stance towards the industry.
- Tax code changes: Some experts are predicting that changes to the U.S. tax code could provide more stimulation for mergers in 2017.
- Mergers and Acquisitions (M&A)
With the market maturing and continued pressure on prices, experts don’t expect M&A to be slowing down anytime soon. Of course, any M&A effort isn’t without its risks. Good deals require solid due diligence and effective strategies around communication and reputation management, which quality management is a key part of.
Cybersecurity is still a top concern for medical device manufacturers. Even though no major breach has yet been reported, the increasing prevalence of online and cloud-connected devices means this concern isn’t going away for consumers. In fact, a survey by consulting experts PricewaterhouseCoopers (PwC) showed more than half of patients would avoid or be wary of a device if a cyber breach occurred.
For continued growth of the market, it’s clear that companies’ risk management processes must remain a top priority for manufacturers of connected medical devices and be applied to the lifecycle of the product.
- Investing in Innovation
Slow market growth means many medical device companies are looking to innovation as a way to improve competitive advantage. In fact, they’re spending an average 7% of revenue on research and development, a figure that’s higher than many other industries.
- Wearable Devices
Wearable devices such as glucose monitors for diabetic patients are becoming increasingly prevalent in the medical device industry. According to a Kalorama Information report, the market was valued at $13.2 billion last year. Healthcare devices are one of the fastest-growing segments of wearable devices, which may play a key role in helping monitor the health of aging patient populations.
Also called electroceuticals, bioelectronics allows implantable devices to stimulate biochemical changes normally driven by drugs. Potential applications include nerve-stimulating devices for treating conditions such as arthritis, high blood pressure and chronic pain.
This field is still emerging, with many clinical trials still years away. For now, companies must focus on innovating the right materials and power sources appropriate for long-term use in the body.
- Artificial Intelligence
Artificial intelligence (AI) is another hot topic in medical devices today, given the ability of computers to quickly mine huge datasets for better decision-making. Potential applications include areas such as clinical trial matching and reading images, but we’re still in the early stages and likely to see things develop more over the coming year, like Deep Learning.
No matter what lies ahead, it’s clear that quality management will remain a key strategy for adapting to changes in the market, innovation and regulations. As a result, many companies are adopting cloud-based GMP Compliance Software to improve quality and efficiency and shorten product cycle times, all of which can add up to a significant market advantage.