In 2018 the number of medical devices on the market grew larger than ever before. At Guided Solutions we keep our ear to the ground and provide daily updates on the most important industry developments across innovations, clinical trials, funding achievements, mergers and acquisitions, and regulatory approvals with our global community of medical device professionals.
Here is our editors’ choice of the most popular industry updates we’ve shared with you throughout the year:
Medical devices that changed the world in 2018
According to MedTech Europe, and average of 10% of Europe’s GDP is spent on healthcare, with 7,2% going straight to medical technologies. Europe is indeed one of the world’s hotbeds for medical device innovation, developing solutions for patient conditions ranging from the most trivial to the rarest of all.
Some of the most fascinating products that could one day change millions of people’s lives forever include EnduraGel, an injectable hydrogel for the treatment of aneurysms; CueStim, a smartphone-controlled device that helps overcome some of the daily challenges caused by Parkinson’s disease; and a groundbreaking graphene-based biomaterial capable of regenerating diseased heart tissue.
A novel transcatheter aortic heart valve was successfully implanted into a patient to treat aortic regurgitation. The device, designed and developed by JC Medical, is the first single solution on the US market to treat pure aortic regurgitation as well as a combination of aortic stenosis and regurgitation.
Back in February, various clinical procedures involving a revolutionary endoscopic surgical robot were performed successfully across Germany. The robot supports surgeons during minimally invasive surgery by moving and holding the endoscope, and is part of startup Medineering’s innovative platform for hybrid robotic surgery.
Regulatory highlights
One of the most important clearances achieved over the past 12 months belongs to Neural Analytics, a US company known for its Lucid M1 Transcranial Doppler Ultrasound System for brain blood flow assessment. Neural Analytics won FDA approval for its NeuralBot robotic ultrasound positioner, which works together with Lucid M1 as the Lucid Robotic System. The new technology will boost progress in the treatment of neurological disorders by providing objective patient diagnostic information that will help clinicians assign more appropriate treatment to patients.
Following major media upheaval on the safety of medical devices available on the market, the FDA announced that it will modernise its medical device legislation. The current procedure known as the 510(k) pathway is an expedited approval process that was launched back in 1976 and is the most common way device makers bring their products to market.
The EU strikes back with its own revamped Medical Device Regulation, which is causing widespread industry confusion. Read our dedicated MDR editorial here.
Clinical trials
2018 saw the completion of the largest prospective neuromodulation study in the field of epilepsy with a 9-year follow up. The trial evaluated the Next-Gen RNS® System for refractory epilepsy launched by Silicon Valley-based medtech company NeuroPace, involving 256 patients across 33 epilepsy centres and nearly 1,900 combined patient implant years of follow up. NeuroPace announced the results of the landmark study at the 2018 American Epilepsy Society Annual Meeting.
Mergers & acquisitions
If we have to pick one medical device company that made a profound impact on the industry through M&A activity in 2018, that has to be Stryker. The global leader in orthopaedics made several strategic acquisition deals throughout the year, but the one that stands out the most is the purchase of K2M for $1.4 billion, with K2M chair & CEO Eric Major becoming President of the Stryker’s spine division.
Stryker’s established leadership in the orthopaedic and neurosurgical market, combined with K2M’s culture of innovation and leadership in complex spine and minimally invasive solutions represent a powerful opportunity to strengthen leadership in the $10 billion global spine market.
Follow our blog for more 2018 industry highlights we’ll be sharing after the holidays.
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