Showing all posts written by Clayton Henson
NAMSA, which describes itself as “the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research and regulatory consulting services,” has announced the acquisition of Reimbursement Strategies, LLC.
According to Mass Device, “NAMSA is a medical device firm that “offers integrated laboratory testing, clinical research and regulatory consulting services.” According to NAMSA, Reimbursement Strategies is a consultancy “focused on reimbursement, health economics and market access for the international life science industry” which “places a significant concentration on providing clients efficacious and timely development outcomes through the organization’s expertise in reimbursement strategy, health economics, medical policy research and coverage advocacy.”
Christopher Rupp, VP of NAMSA’s global marketing and commercial operations stated that the acquisition of Reimbursement Strategies “will allow clients to proactively address the largest challenges of bringing novel devices to the global marketplace—securing appropriate coverage and payment for new and existing technologies.” Rupp continued to state that “We look forward to delivering device manufacturers faster, more cost-effective commercialization results through our comprehensive, full-service development solution.”
The former President of Reimbursement Strategies, LLC, Edward Black, stated, “We are very pleased to join the NAMSA Team as we work together to provide clients the most critical services required to navigate our industry’s complicated global reimbursement landscape.” Black, who is now NAMSA’s Director of Global Reimbursement Strategy, asserted that, “It is more important than ever for device manufacturers to assess reimbursement challenges early so they may fully integrate this planning into regulatory and clinical research pathways to achieve resource efficiencies and expedite market commercialization.”
According to Business Wire, “NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines—consulting, regulatory, reimbursement, preclinical, toxicology, microbiology, chemistry, clinical and quality—to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements anywhere in the world.” Business Wire also reports that, “NAMSA operates 13 offices throughout North America, Europe, the Middle East and Asia, and employs nearly 1,000 highly-experienced laboratory, clinical and consulting Associates.”
According to PR Newswire, the Israeli Ministry of Health has granted initial approval to Tel-Aviv-based Kanabo Research for their VapePod vaporizer product as a medical device. PR Newswire notes that with this approval, Israel has become the first country in the world to grant medical device approval for a “vaporizer for the use of medical cannabis extracts and formulations.” High Times, a cannabis-related publication, goes further to say that this is the first certification of marijuana “‘paraphernalia’ as an accepted medical device.”According to Israel21c, Kanabo claims that the approved vaporizer will provide for “more effective, consistent, and accurate dosing and delivery methods than currently accepted medical cannabis treatment methods.” Cannabis administration “has long frustrated doctors due to lack of precise dosage” according to The Jerusalem Post. It reports that Kanabo says the VapePod will solve this problem with its “consistent and accurate gauge.” Moreover, The Jerusalem Post notes that many medical cannabis patients inhale by smoking, and that vaporizers “reduce health risks and make inhalation more effective.”
Israel21c also reports that Kanabo’s next version of the approved VapePod – the VapePod MD, will “monitor patient usage and gather usage data for caregivers, doctors and research applications. PR Newswire reports that Kanabo has initiated pre-clinical trials and is “achieving impressive results in early findings” with their targeted formulations for sleep disorders that are designed to be used with the approved VapePod. Kanabo also has two patents pending which are directed to the formulations according to PR Newsire.
Kanabo Research was founded in 2016 and currently employs 12 people according to The Jerusalem Post. Co-Founder and CEO of Kanabo Research Avihu Tamir had this to say about the future of the company: “We expect that due to the transition of most of the cannabis consumers to the use of vaporizers, our company is projected to reach $10 million in sales within three years in the Israeli market, while the Israeli cannabis market is expected to reach $100 million in sales within three years. The Israeli market is a platform to deliver our technology to global markets in North America and Europe.”
The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017. This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA. Previously, companies had to submit a report within 30 days of a problem. Under the current version of the Reauthorization Act, companies will be able to submit reports once every three months instead. Additionally, these reports will be able to “summarize previously reported product malfunctions, rather than filing detailed reports on each case” as reported by the StarTribune. However, this does not affect the 30-day reporting requirement for medical device companies to report “adverse events” or anything that result in actual injury to consumers.
This measure is part of a piece of legislation that must be renewed every five years and which sets the fees that device makers pay the FDA to review their products. The goal of the agreement from the device maker’s perspective is to reduce the time it takes for the FDA to review products and get them to market. According to the New York Times, this bill “compels the F.D.A. to speed medical devices onto the market — and into patients — faster than ever.” But this may not be in patients’ best interest, because medical device malfunctions are already “vastly underreported” as acknowledged by the FDA.
StarTribune reports that proponents of the change say that it would “simplify the needlessly repetitive process of reporting known product problems.” Minneapolis-based med-tech regulatory attorney Mark DuVal said that “A lot of MDRs (Medical Device Reports) are really boilerplate and repetitive,” and that “[i]t would be nice to be able bundle them.” According to the StarTribune, DuVal thinks that the current system of reporting MDR’s creates a lot of work for companies while doing little to inform doctors about issues that are known. Janet Trunzo, a senior executive vice president with the lobbying group AdvaMed, said in a statement that the reporting provision “will allow the agency to better focus its resources on more serious reportable events.” According to Trunzo, the quarterly summary reporting only applies to well-understood and familiar malfunction incidents. Medical device companies would still be required to file an individual report on any malfunction incident that had not been previously reported.
According to the New York Times, critics of the change do not think relaxing the rules is proper when so much already goes unreported. Jack Mitchell, director of health policy for the National Center for Health Research, said that “[p]ost-market surveillance of medical devices continues to be dangerously slow and clearly inadequate to protect patients from risky devices.” Mitchell thinks that loosening up the reporting rules will “exacerbate the tendency to underreport.” Ms. Tomes, who is now the chief executive of Device Events, which mines FDA’s device data to find signals of problems, also does not think this loosening of the reporting rules is in the public’s best interest. Ms. Tomes pointed out that last year, many reports about battery depletion of cardiac defibrillators were reported as “malfunctions.”
The bill still needs to be passed in the Senate before being signed into law by President Trump.