Sandra Maddock, President & CEO of IMARC Research
With new technology and groundbreaking medical device news making headlines every day, there has never been a more exciting time to be involved in clinical research. So much is changing so fast — faster than at any other time in the history of clinical research.
At IMARC Research, we take pride in innovation. We’re constantly monitoring medical device trends and regulatory updates to determine how they might apply to the clinical research teams who enlist our oversight.
We know this will be a transformational year, so we’re excited to kick off 2019 with a series that highlights the most important medical device trends you need to know. In this post, we’ll focus on the biggest medical device stories to watch this year, then take a closer look at each in upcoming blog posts.
The biggest medical device news stories to watch
- The use of wearable devices in clinical trials
- More smart medical devices
- Medical devices to prevent and treat opioid addiction
- Stronger regulations in the FDA’s 510(k) program
- More post-market data collection
- Less invasive heart surgery
1. The use of wearable devices in clinical trials
Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. The potential of these devices to assist with data collection in clinical trials is huge.
Patient-generated data is faster to collect and respond to, allowing researchers to monitor patients closely and intervene quickly when adverse events occur. Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description. We expect to see the use of medical wearable devices in the marketplace and their use in clinical research explode in the coming years.
However, this trend isn’t without challenges. Clinical researchers using wearable devices to collect patient data need to ensure patients are trained to use them properly in accordance with study guidelines.
They also need to determine how to collect and store the data they collect through these devices, particularly if they come from multiple vendors.
2. More smart medical devices
Globally, the smart medical device industry is growing fast. The market was estimated at nearly $33 billion in 2017 and is expected to nearly double over the next six years, reaching almost $64 billion by 2024, according to Zion Market Research.
Smart medical devices are being used in a variety of applications ranging from diagnosis, monitoring, therapy and injury prevention.
Here are just a few examples:
- Wearable devices FallSkip, which analyzes balance, gait patterns and other risk factors for falling among elderly patients, and Hip’Safe by Helite, which minimizes the impact of a fall
- A portable visor that sends low-energy radio waves through the brain to detect strokes in patients with 92 percent accuracy
- Smart socks that measure foot temperature to detect skin inflammation in people with diabetes, which helps prevent ulcers that can lead to amputations
3. Medical devices to prevent and treat opioid addiction
The opioid epidemic now kills more Americans than HIV, car crashes or gun violence.
In 2017, more than 70,000 people died from drug overdoses, according to a New York Times analysis of CDC records. That’s nearly 200 people each day or eight people every hour.
As part of its efforts to combat this crisis, the FDA launched an innovation challenge last May to spur the development of medical devices that prevent and treat opioid use disorder.
Medical device developers submitted more than 250 applications, and the FDA selected eight.These devices include:
- A rapid drug screen
- A deep transcranial magnetic stimulation (DTMS) device
- Virtual reality neuropsychological therapy and other systems to treat pain
- A smart pill dispenser
These developers will work directly with the FDA to accelerate the development and review of these medical devices.
4. Stronger regulations in the FDA’s 510(k) program
The FDA recently released an action plan to further ensure the safety and effectiveness of medical devices. This plan, known as The Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, includes strengthening the 510(k) Program, which allows new medical devices that are “substantially equivalent” to an existing device to be exempt from the pre-market approval process.
The FDA has already implemented some of these additional regulations, including increasing the documentation it requires for each 510(k) submission and increasing the time it spends reviewing them.
It’s now seeking public comment on how to further strengthen the 510(k) Program by making information about older medical devices more readily available.
5. More post-market data collection
Another priority for the FDA is increasing post-market data collection and surveillance of medical devices.
The FDA has already taken several steps to do this, including:
- Establishing a new national system for gathering real-world evidence (NEST) and recently requesting $46 million in additional government funding to support it
- Conducting test case demonstration projects using real-world data, such as comparing the safety and effectiveness of different tissue closure techniques and evaluating the safety of intervertebral body fusion devices to treat spinal conditions
- Generating clinical evidence about medical devices used in women’s health, such as breast implants, vaginal rejuvenation devices and surgical mesh used to treat transvaginal pelvic organ prolapse
The Medical Device Reporting regulation 21 CFR 803 already contains mandatory requirements for manufacturers and facilities that use medical devices to report certain adverse events and problems to the FDA. The new European Medical Device Regulation (MDR) will also require all manufacturers who sell medical devices in Europe to follow more stringent regulations, including additional post-market surveillance.
Clinical researchers need to be prepared to update their processes for data collection and review to comply with the new European MDR regulations.
6. Less invasive heart surgery
Major innovations are coming in the way surgeons approach heart surgery. Expect to hear a lot more about mitral and tricuspid valve percutaneous replacement surgery (heart surgery performed through a catheter in the skin.)
This less invasive approach saves lives while reducing recovery time and re-admissions.
The first of these surgeries was performed in 2016 and involved replacing a valve stent through a catheter. Now, medical device companies are racing to bring the first transcatheter mitral valve replacement to market. Abbott is leading the way with its MitraClip TMVR device, but there are at least seven other companies investing in this new technology, according to a Medical Design & Outsourcing article.
How will the latest medical device news impact clinical research?
Clinical researchers have a lot to consider when it comes to testing smart devices, using wearable devices to collect patient data and conducting post-market surveillance to comply with new regulations.
Because this is largely uncharted territory, many of the questions that arise will need to be addressed on a case-by-case basis.
Ensuring patient protection and data integrity starts with a team of well-trained researchers who who fully understand the FDA regulations and latest Good Clinical Practice standards including ICH E6 (R2) and ISO 14155. An experienced contract research organization like IMARC can offer third-party oversight and consulting on these issues so your trial can keep moving forward.
Check out this whitepaper to more about how to hire a compliance-minded CRO. And take a moment to subscribe to our blog for more medical device trends you need to know.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
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