There are about 466 million people worldwide with disabling hearing loss, 48 million of them in the US. To date, hearing aid devices have been the only solution to sensorineural hearing loss, the kind that comes from aging and the damage loud sounds cause. Eyeing the potential blockbuster opportunity, pharmaceutical companies like Decibel Therapeutics have finally joined the fray.
Robotics were the hot topic at NASS 2018, but discussions also raged about advanced implant materials that have the potential to promote better bone growth and faster healing and reduce reliance on expensive biologics to achieve those goals. An excerpt from Senior Writer Wendy Diller’s November 16 feature, “At NASS 2018, Advanced Biomaterials and the Pull of Robots.”
Apple recently made a splash with its new ECG-enabled watch, but technology from an Israeli start-up may have a better chance of penetrating the multibillion-dollar ambulatory cardiac arrhythmia monitoring market. An excerpt from Executive Editor Mary Thompson’s October 31 feature, “Ambulatory ECG Monitoring Enters a New, More Patient-Friendly Era.”
Behemoth online retailer Amazon is setting its powerful sights on the medical device supply chain. Will the Internet giant have the resolve to invest in the competencies and infrastructure necessary to meet the regulatory demands of healthcare logistics? It faces a number of tailwinds and headwinds in its run at disrupting the healthcare market, says Larry Smith, retired Vice President, Global Supply Chain at BD.
Innovation in the device space isn’t just about next-generation technologies—it also defines the forward-thinking role of today’s medical device supply chain. Here, we look at three key issues impacting supply chain organizations that companies of all sizes need to pay attention to as they grow, expand into developing markets, and as the industry consolidates, according to industry veteran Larry Smith, retired VP, Global Supply Chain at BD. One potential game-changer on the horizon: Amazon.
Last November, FDA issued a long-awaited, final guidance on its standards for overseeing human cell and tissue products. It is the latest move in an ongoing effort by the agency to wrap its arms around the complex, evolving, and controversial area of tissue-based biologics and, by extension, the newer, fast-growing field of regenerative medicine. An excerpt from Senior Writer Wendy Diller’s October 17 feature, “Regulatory Shifts for HCT/P Products Put Orthobiologics Manufacturers on the Spot.”
Sloan Gaon, CEO of PulsePoint, a programmatic health technology company that uses data and technology to engage consumers and personalize healthcare advertising on the web, talks with the Community Blog about how the new Apple Watch and other tech and data initiatives are driving the shift to “radical health personalization.”
At the recent MedTech Conference powered by AdvaMed, held in Philadelphia, the Community Blog caught up with Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health (CDRH) at the FDA. We asked him what he thought about today’s medical device regulatory climate, and where he sees the industry overall headed in the next few years. Hint: Shuren’s optimistic vision for the future of the CDRH embodies the overall theme of everything we do here at the Community Blog - build a community. Our Q&A is included below.
DeNovo Ventures’ Managing Director Joe Mandato speaks with minimally invasive surgery/robotics pioneer Fred Moll, MD. Moll founded three public robotics companies, co-founded Origin MedSystems and Gynecare, and recently raised a record amount of capital for a new device company, Auris Health. Moll is an innovator, entrepreneur, and seasoned board member, and he speaks with Mandato about board governance.
Neuro-focused prescription digital health companies are taking aim at a range of diseases from psychiatric and mental health disorders to neurodegenerative diseases. In this excerpt from our September 28 feature, “Digital Taps Into Neurological Function,” Mark Ratner talks with William Marks, MD, about Verily Life Sciences’ activities in the field.
gBETA Medtech Accelerator, launched this past March, is the first accelerator of its kind to tap into the rich medical device, digital healthcare, diagnostics and biotech ecosystem that exists in the Midwest Medical Alley region. Its goal is community building, and fostering innovation among the most promising of today’s early-stage start-ups. The program is funded by Boston Scientific, with additional support from Mayo Clinic, University of Minnesota, and Medical Alley Association.
Carbon’s unique 3D liquid interface process creates the products it prints out of a pool of liquid, an approach that it says overcomes the challenges of traditional layering. The well-funded start-up has partnered with big players in numerous industries. Johnson & Johnson invested in its latest financing round, which points toward opportunities in medtech. An excerpt from Editor-in Chief David Cassak’s recent profile of Carbon.
NASS, the year’s biggest spine surgery gathering, begins next week in Los Angeles amid a hot medtech financing market and tides of disruption—if a slow-shifting market like spine can be disrupted. We’ve put together a crib sheet on the key trends in M&A and R&D we will be watching for at the meeting, based on interviews in recent months with leading spine surgeons, analysts, and industry execs.
In Part 2 of our interview, Rick Valencia, President of Qualcomm Life, tells us about his company’s recent partnership with AlertWatch Inc. to provide real-time intelligence to anesthesiologists in the operating room (and those monitoring patients remotely). He also talks about what’s next in the evolution toward value-based care, and his personal passion for the medtech industry.
The Community Blog caught up with Rick Valencia, President of Qualcomm Life, three years after his Q&A interview with MedTech Strategist’s co-editor-in-chief, David Cassak, to find out where we stand with the value-based healthcare evolution, and Qualcomm Life’s initiatives in this important area. In Part 1 of our interview, Valencia talks about the current status of mobile health and wireless connectivity in the device space, what still needs to happen, and how his company is helping to propel this movement forward.
Conventional wisdom has held that medtech companies could only be successful if they were willing and able to tackle the US market, but two decades ago Biosensors International built an extremely successful interventional cardiology business by bypassing the US to target Japan and, at the time, a nascent Chinese market. We share an excerpt from David Cassak’s conversation with Biosensors’ former CEO Yoh-Chie Lu.
Virtual reality and other tech-enabled digital tools are entering the healthcare education arena with a promise to make clinician training and assessment more flexible, efficient, and user-friendly. One of the most active pioneers in this space is medtech giant Johnson & Johnson. J&J’s professional education unit, the Johnson & Johnson Institute, is embracing a variety of digital learning tools, ranging from virtual and augmented reality to AI-driven online learning tools. And its efforts could have far-reaching implications for both J&J and the clinicians it serves.
For the past couple of years, the idea of a US medtech/diagnostic public market has been just that—an unrealized hope. Despite quarter after quarter of promising signs, the US IPO window remained basically closed to device and diagnostic companies. That inactivity continued through the first quarter of this year, but Q2 brought several deals and prompted increased optimism that the public market would once again be open to medtech offerings.