Health care is in the midst of a major transformation as data becomes the focal point of vital decisions that will affect patient care and everything used to deliver that care. Just as other industries have found ways to utilize data analytics to turn “Big Data” into a cost savings and efficiency tool, so too is health care moving to embrace the potential of Big Data to both improve patient care and impact the bottom line. For device manufacturers, this shift could bring a fundamental change in the way medical products are assessed, adopted, and reimbursed.
Despite the dire headlines, VCs are still investing in medtech start-ups, although the deals are becoming fewer and later stage. Start-ups looking for funding have to be more creative and look beyond traditional sources of funding, according to a discussion by six European venture capitalists speaking at the IN3 meeting in Dublin in April 2013.
Orthopedic companies now target the so-called extremities as an area of capable of producing double-digit growth in sales. To be sure, the markets are considerably smaller than hips or knees, but multinational leaders can’t ignore untapped potential when their core markets are stagnant, and a new front is forming in the battle for foot and ankle supremacy around an old but still underutilized device – total ankle replacement implants.
Patent attorneys suggest lawsuits from firms that buy up device patents purely to pursue litigation, which appears to have occurred recently with Medtronic’s kyphoplasty patents, may become a more common occurrence.
With health care becoming increasingly data driven, third-party payors are requiring a higher level of evidence before making a positive coverage determination for a new technology or procedure. This has made the road to reimbursement much longer and tougher for device companies in general, and manufacturers of transoral devices for GERD are a prime example.
Even with all of the advances and options in heart failure therapy, there remain no real options for a large number of patients who are seriously ill but not yet at the end-stage of the disease. CircuLite hopes to change that with a partial support device for patients who don’t need a VAD.
Topera Medical questions the assumptions underlying current therapies for atrial fibrillation. Sanjiv Narayan, MD, PhD, the electrophysiologist who founded Topera, has developed a means of identifying focal sources of aberrant electrical activity called rotors, and in late breaking clinical trials at the 2013 annual meeting of the Heart Rhythm Society, was able to show a definitive link between their ablation and treatment success.
The agency issued a draft guidance and safety communication last week in response to a recent emergence of cybersecurity breaches occurring in wirelessly connected medical devices in hospitals.
The current technologies for diagnosing spinal disease don’t consistently deliver what’s required of any medical diagnostic: good predictive value, high specificity, sensitivity, validity, reproducibility, and safety. This is a gap that several young, innovative companies have set out to fill.
Robotic-controlled surgical tools – led by market leader MAKO Surgical Inc. – are beginning to take root in the knee surgery market, at least in partial knees. Perhaps the truest measure of the potential of this market is the growing competition that MAKO is facing: just over the past five months, Blue Belt Technologies and Stanmore Implants Worldwide received FDA approval for rival robotic surgical systems.
