Recently I had the privilege of co-presenting a session at the RAPS 2017 Regulatory Convergence with former colleagues from Regulatory & Quality Solutions (R&Q) and members of the FDA. Read more about the session here.
The long-term vision for wearables in healthcare includes an active role restoring patient health, preventing certain diseases by promoting behavioral changes, and ultimately, promoting healthier lifestyles, leading to improved overall health.
At least 2.7 million Americans are living with AFib, according the American Heart Association (AHA), and that number likely is close to 45 million people worldwide. What advances are being made in the management of this condition?
Understanding the most common causes of material failures in medical devices can help manufacturers make better design decisions up front and avoid surprises after product launch.
There are a wide variety of materials to choose from when it comes to micro medical components. In this article, MTD Micro Molding answers some of the most commonly asked questions about bioabsorbables.
Selecting and validating the best dual-chamber design option for the delivery of a given pharmaceutical.
How development teams need to engage in the holistic, programmatic risk management necessary for a predictable development program.
As new technologies are incorporated into POC diagnostics, the challenges of taking product from design to full-scale commercialization increase. Is your supplier model as efficient as it could be?
Medical device design and development is the cyclical process of creating a device for a specific task or set of tasks, and then continuously reevaluating its effectiveness and improving upon it until the device reaches obsolescence. Design and development begins with ideation and the creation of a concept that, if found to be both fiscally and clinically viable, is then designed, engineered, and prototyped. This preclinical period includes bench testing — accomplished through simulated use of the product — and animal testing, along with any necessary redesign work.
Throughout the process, the proposed medical device, and the process by which it will be manufactured, is examined for flaws that may negatively impact the device’s safety, market viability, regulatory acceptance, customer satisfaction, usability, or profitability. Any shortcomings are corrected, and the improvements applied to the final design. Due to the wireless connectivity capabilities of many modern medical devices, cybersecurity and interoperability also must be incorporated into the design. Clinical testing is conducted, using human subjects, to further expose flaws and confirm product strengths. Once both the product design and the manufacturing process have been validated and approved by the U.S. Food and Drug Administration (FDA), production and commercialization of a device may begin.
Scientists at the University of Edinburgh and Heriot-Watt University, through the Proteus Interdisciplinary Research Collaboration, have developed a new camera that can image individual photons emanating from fiber optic medical instruments inside the human body.
Researchers from the NIH Clinical Center Rehabilitation Medicine Department have created the first robotic exoskeleton specifically designed to treat crouch (or flexed-knee) gait in children with cerebral palsy by providing powered knee extension assistance at key points during the walking cycle.
Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today introduced its X-ray-based Patient Specific Instrument, X-PSI™ Knee System, which is the world's first CE Marked surgical planning system that allows for patient specific implant positioning solely utilizing X-ray technology.
A National Institutes of Health-funded study led by a team at the Georgia Institute of Technology and Emory University has shown that an influenza vaccine can produce robust immune responses and be administered safely with an experimental patch of dissolving microneedles.
Hill-Rom has unveiled an airway clearance system that is integrated into a mobile vest and allows patients more freedom of movement while receiving their respiratory therapies.
Successfully miniaturized multimodal optical technology combines three nonlinear imaging techniques into one probe, said German scientists.
A team of Australian scientists has just completed a phase one human clinical trial with an ingestible biosensor that can measure gas produced by the gut, and potentially transmit results to a connected smartphone.
Scientists in South Korea are mining the biomedical potential of both gold and graphene to design a more flexible brain-machine interface (BMI) that can transmit clearer signals while causing minimal damage to brain tissue, said researchers.
With Verily’s new “investigative watch,” the only information the clinical trial participant can view is the time and date, but researchers have access to a host of physiological data and biomarkers, including heart rate, activity data, and electrocardiograms (ECGs).
Toyota Motor Corporation will launch a rental service for the Welwalk WW-1000 robot from the fall of 2017.