ANAHEIM, Calif. – Most medical device manufacturers follow a traditional, linear, task-driven approach for product development. Switching to a knowledge-driven approach, called agile-lean, may yield better results. That was the takeaway from a talk at MD&M West.
Health and Human Services (HHS) Secretary Alex Azar was peppered with questions about the Trump administration’s budget proposal for fiscal 2021 during a Feb. 13 Senate hearing. However, another theme that resonated during the hearing was Senate legislation addressing drug prices. Azar addressed the issue of price caps, while noting that the bill “leaves plenty of room” for both ample profit margins and innovation in drug development.
The latest mutation to the coronavirus, dubbed COVID-19, has sparked a reaction by many national governments, but the expense associated with development of vaccines and diagnostics is considerable. Ron Klain, who served as the Obama administration’s coordinator for the response to the Ebola virus, said during an Aspen Institute seminar that drug makers took a hit in their efforts to develop a vaccine for the Ebola virus, and thus there is a need to de-risk these and other development efforts in the private sector.
A half-day open meeting intended to examine “how the public perceives and values pharmaceutical quality,” convened by the Robert J. Margolis Center for Health Policy at Duke University in cooperation with the FDA, included a rundown of the agency’s oversight program, results of surveys to measure viewpoints of patients and providers – and tart commentary from a two-member “reactant panel.”
The Dec. 9, 2019, FDA draft guidance spelling out performance criteria for magnetic resonance coils seemed to take up a relatively simple matter, but industry’s response suggested otherwise. The Medical Imaging & Technology Alliance (MITA) recommended that the agency undertake nearly two dozen changes to the draft, including a change to the title to indicate that the scope of the guidance is limited to receive-only MRI coils.
In a budget proposal sure to spark opposition, the Trump administration has proposed to provide the National Institutes of Health with only $38 billion in fiscal 2021, several billion dollars short of the agency’s funding for the current fiscal year. The proposal also calls for funding of less than $95 billion for the Department of Health and Human Services, a 10% reduction in funding that includes an adjustment for drug pricing proposals and a $5 million cut to FDA monies for the 21st Century Cures Act.
The advent of transcatheter aortic valve replacement (TAVR) changed the framework for dealing with aortic valve stenosis, but some clinicians might argue there was a corresponding and inappropriate rush away from surgical aortic valve replacement (SAVR).
Houston-based Nanospectra Biosciences Inc. has kicked off a pivotal U.S. study of its Aurolase therapy in the targeted destruction of prostate tumors using nanomedicine technology. The IDE study, with an estimated completion date of December 2022, will support a de novo 510(k) submission to the U.S. FDA. The first two patients were treated at the University of Michigan, which also participated in the first-in-human pilot study of Aurolase.
FDA warning letters to device makers have been conspicuous in their paucity in recent years, but they have been surfacing with greater frequency over the past few months.
Becton, Dickinson and Co. (BD) (NYSE:BDX) reported revenue of $4.23 billion for the first quarter of fiscal year 2020, ended Dec. 31, up 1.6% from the same period a year ago. Revenue grew 2.5% on a currency-neutral basis. However, an unexpected regulatory hurdle for its Alaris infusion pumps caused the Franklin Lakes, N.J.-based company to lower its 2020 revenue and earnings guidance. Despite the shadow cast by the Alaris news, BD beat Street expectations for the quarter – clocking in at $4.23 billion vs. $4.18 billion.
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