Here is the latest batch of news from the medical products community. Please click the link for more.
Regulatory Approvals, Standards, and Launches
Kyocera Medical, San Diego, CA, a manufacturer of implantable systems and advanced ceramic components, has received the FDA 510(k) clearance for its Initia® Total Hip System. Designed for a global patient population, the Initia system includes a total of 16 tapered-wedge stem sizes, 12 of which are available in the U.S., with both standard and high femoral offsets.
CDRH intends to focus on leveraging “big data” for regulatory decision making and modernizing biocompatibility and biological risk evaluation of device materials, according to AAMI’s assessment of CDRH’s list of regulatory science priorities for the upcoming year. Regulatory science “helps ensure that regulatory decisions are well-founded and achieve the desired impact on public health,” the Center for Devices and Radiological Health (CDRH) wrote in its 13-page report . “It facilitates good decision making in the areas of premarket evaluation, postmarket surveillance, compliance, and communication.”
Leadership News
Novelda, Oslo, Norway, a developer and manufacturer of adaptive smart sensors, has also appointed Cornelia Mender as its new CEO. Mender comes from GE Vingmed Ultrasound where she led the supply chain operation for cardiovascular ultrasound systems. The company also announced a further $12 million funding round to take its XeThru vital signs and true presence sensors into high-volume production.
Expansions/Spinoffs/New Services/Moves
Spiral Medical Development has moved its medical device courses to new landing pages. To see the courses available, go to http://medicaldevicecourses.com.
Mergers/Acquisitions/Collaborations/Licensing
Ecliptek, Costa Mesa, CA, a global manufacturer of crystal and oscillator products, has announced a formal agreement with Doran Associates to represent the frequency control company in Oregon, Washington, Idaho, and Montana. A manufacturer's representative since 1968 and long-standing ERA member, Doran adds a crystal and oscillator line to complement its extensive component line card. The company has also announced the addition of Sheila Hoagland as its new Business Development Manager, based out of its Costa Mesa, CA headquarters.
Industry/Market
Rotation Medical, Plymouth, MN, a medical device company focused on developing new technologies to treat rotator cuff disease, has announced results of a biopsy study published online in Arthroscopy that supports the biocompatibility of the company’s bioinductive implant and its ability to promote new connective tissue with the histological appearance of tendon. The Rotation Medical bioinductive implant is part of the company’s novel rotator cuff system for rotator cuff repair and a new alternative to traditional surgical repair.
The American Heart Association (AHA) launched the Center for Health Technology & Innovation in September to focus on finding technology solutions to healthcare problems. The center will work with medical professionals, technology partners to find ways to improve outcomes, lower costs and increase engagement through technology. According to AHA, CHTI helps its collaborators in the healthcare technology field align and integrate their technology with AHA resources to encourage development and adoption of digital healthcare solutions. These companies can also participate in forums, integrate with research platforms, and potentially collaborate on innovative healthcare solutions with established companies and startups.
Six pediatric medical device innovations that address a significant unmet need were awarded a total of $250,000 in grant money at the 4th annual Pediatric Surgical Innovation Symposium organized by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System. Winning innovations are:
- Maternal Life, Palo Alto, Calif. – low-cost closed system that captures and administers colostrum to newborns with zero percent loss
- JustRight Surgical, Louisville, Colo. – second-generation surgical 5 mm stapler scaled for a wider range of pediatric surgical procedures and bringing the benefits of laparoscopy to patients
- Lully, San Francisco, Calif. – moisture sensor and Smart Pod monitor wirelessly connected to a smartphone app to prevent bedwetting episodes
- Center for Advanced Sensor Technology, University of Maryland Baltimore County, Baltimore, Md. – low-cost, disposable multifunctional incubator for at-risk, low birth weight babies • Nebula Industries, Melrose, Mass. – quick-release medical tape to prevent neonatal and pediatric skin injuries
- May & Meadow, Redwood City, Calif. – low-cost, mobile medical device for assessing feeding ability in infants at risk for feeding problems
AdvaMed has issued a new report designed to further advance a comprehensive set of policy objectives to invigorate the innovation ecosystem for early-stage device and diagnostics companies. The report – “A Future at Risk: Economic Performance, Entrepreneurship, and Venture Capital in the U.S, Medical Technology Sector” outlines significant warning signs that AdvaMed says if left unaddressed could hamper long-term growth and entrepreneurship. Some key signals identified in the report, based on a number of independent sources on medtech industry trends, include:
- A sharp decline in the number of new medtech start-ups each year, going from around 1,500 annually 30 years ago to around 600 in 2012.
- The U.S. medtech industry is “graying,” with more than 30 percent of medtech firms at least 25 years old and more than half 16 years old or more.
- Since the early 1990s venture capital (VC) investment in the industry has gone from about 13 percent of total VC dollars to about 4 percent in recent years.
- The proportion of VC funds devoted to early stage start-ups – which are dependent on these funds to survive in many cases – has gone from about 10 percent in the early 1990s to only 3 percent in recent years.
PA Consulting, London, a global consulting firm specializing in the healthcare industry, has conducted a study that found reducing the time to market is the number one need among medical device companies. Key findings of the research include:
- Reducing time-to-market is seen as one of the most important drivers of staying competitive – only beaten to the top spot by product innovation – and is followed by efficient product development.
- Organizations are targeting an average reduction of 25% in the next five years for development time and costs to remain competitive.
- It’s clear that organizations have a common understanding of the measures they need to take to achieve this reduction.
- There is a huge gap between respondents’ own capabilities, the estimated level of their competitors’ capabilities, and the actual best practices of respondents.
