When designing a medical device, nothing beats direct observation of, and feedback from, the people who will be using it. Ideally, this research is performed as a close partnership between the human factors (HF) researchers and the engineers who will be working on the device.
As patient-centered care and mHealth have become driving forces in health care, digitally connected health technologies have emerged as a solution to engage patients and collect data. But patient and provider adoption of these devices can be a challenge.
Though neurostimulation procedures have been performed for decades, recently, the improved understanding of neural circuitry has led to a desire for a new generation of neuromodulation devices.
Clear trends are emerging, some helping to push connected healthcare forward and some that are slowing down progress. Identify the opportunities and challenges arising as drug delivery devices are becoming part of the connected world.
This article explores the rise of connected health services and smart device solutions in the pharmaceutical market and how these tools are leading the trend toward patient centricity by enabling direct interaction with end users using real-life data.
Understanding what is involved in injection-molding process validation and why it is important will help you choose a molding partner who can provide you with the confidence that your plastic parts will work well every time.
The biopharmaceutical industry is not immune to the new opportunities that mobile and ‘Cloud’ technologies are opening up for new service and business models. Applications that will thrive on this new technology will improve patient outcomes and deliver strong return on investment for service providers.
While the concept of RADAR (RAdio Detection And Ranging) is firmly entrenched in the common vernacular, the what and how of radar technology is not as broadly understood.
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.
Cianna Medical, Inc. has received FDA clearance of the SAVI SCOUT® reflector for long term implant. The SAVI SCOUT reflector is an integral part of the SCOUT system for wire-free breast tumor localization.
Researchers at Binghamton University, State University of New York have created a micro-scale biological solar cell that generates a higher power density for longer than any existing cell of its kind.
Six companies presenting innovative medical device solutions that address significant unmet needs in pediatric health were awarded a total of $250,000 in grant money yesterday in San Jose, Calif.
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.