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Compliance In Focus
Posted by John Lehmann on Fri, Jan 24, 2020

Four Medical Device Trends To Watch in 2020

To stay on the leading edge of innovation, today’s medical device manufacturers need to stay up to date on the latest trends and technologies.

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At IMARC, our team keeps a close eye on medical device news and regulatory updates to determine how they might apply to the clinical research teams that enlist our oversight.

We’re excited to kick off 2020 with a few of the most important medical device trends you need to know. Here are four trends we’ll be watching.

4 Medical Device Trends For 2020

Artificial Intelligence

Perhaps the most profound changes transforming healthcare today are medical devices that incorporate artificial intelligence (AI) and machine learning. This technology is being used to diagnose conditions, identify disease and create efficiencies in everything from clinical trials to clinical practices. It will likely lead to more personalized, targeted treatments based on patient needs.

Last year, the FDA introduced new guidance for this emerging segment of the healthcare technology market, stressing the need to provide guardrails without stifling innovation or restricting access to breakthrough technologies for patients.

Because these devices rely on algorithms that continually learn and adapt, the FDA approval process will need to be different than the traditional step-by-step approach to regulating medical devices. Developers will need to ensure the models for medical devices that use artificial intelligence are properly validated and documented. Any changes to the algorithm will also need to be documented, but not every change will require FDA approval, former FDA commissioner Scott Gottlieb said in a statement.

“The goal of the framework is to assure that ongoing algorithm changes follow pre-specified performance objectives and change control plans, use a validation process that ensures improvements to the performance, safety and effectiveness of the artificial intelligence software, and includes real-world monitoring of performance once the device is on the market to ensure safety and effectiveness are maintained,” he said.

Robotics

Collaborative robotics like the da Vinci surgical robot have been assisting surgeons in the operating room for a while now. The field of robotics is profoundly changing healthcare today – way beyond the bounds of the surgical suite. Robots are helping doctors treat and rehabilitate patients, automating research laboratories and are even helping disinfect hospital rooms. Experts like McKinsey project tremendous growth in this sector of healthcare with this market reaching $20 billion by 2023. The technology shows particular promise for telemedicine in rural areas.

Nanotechnology or microbots are also very promising; robots work inside the body to target a specific area like a tumor. They can be controlled using an electromagnetic field or navigate on their own through bodily fluids.

Genomic Medicine

Utilization of a patient’s genomic data to make healthcare decisions is a promising trend for 2020 and beyond. Genomic medicine has tremendous potential in the areas of pharmacology, oncology and infectious disease medicine. Innovation in this field is fueled by artificial intelligence and machine learning, which have both helped to significantly advance genomic medicine by increasing the data processing time needed to analyze genes and gene mutations.

The National Institutes of Health report that the field is reaching its fruition, based on the foundational work of the Human Genome Project that decoded the human genome. That extraordinary research effort has paved the way for precision medicine, allowing doctors to use genomic data, environmental exposure data and other data to personalize healthcare to guide an individual diagnosis.

Because this technology is so new and rapidly evolving, it remains to be seen how the FDA will regulate it.

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Extended Reality

Extended reality modes like virtual reality, augmented reality and mixed reality have been transferred from the entertainment industry for important uses in healthcare, such as surgery simulation and patient care and treatment. Virtual reality has been applied to help patients with everything from depression to visual impairment, and the technology shows tremendous application for medical training. According to BIS Research, the global market for AR and VR in healthcare is expected to grow to $11.4 billion by 2025.

AR allows researchers to gather data in 3D format. Data on the human body can be gathered digitally, then presented in 3D view. This has the potential to transform the way physicians plan and execute medical procedures and even conduct research.

Therapeutic imaging also has the potential to be transformative for diagnostics and treatment, making the process easier for patients.

Stay Up to Date On The Latest Medical Device Trends

Because this is largely uncharted territory, many of the questions that arise will need to be addressed on a case-by-case basis. An experienced contract research organization (CRO) like IMARC can offer expert oversight and consulting on emerging medical device trends 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.

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Topics: Medical Devices

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