A talk with Steven Morris, founding partner, CEO, president, and board member of BIOLIFE4D. His company is leveraging advances in life sciences and tissue engineering to 3D bioprint a viable human heart suitable for transplant.
In the past 18 months, the FDA and DHS have been warning the medical device industry about the danger of cybersecurity vulnerabilities in networked medical devices. But the number of medical device cybersecurity alerts has more than tripled in the last three months. Is this an anomaly or the new normal?
The human body is miraculous in its ability to heal. We cut ourselves shaving and the wound quickly scabs over, healing completely in a couple weeks. We break a bone in our arm or leg and the ends of the broken bone knit themselves back together, healing in a couple months. But, what happens when we injure our brain?
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.
Extremely fine porous structures with tiny holes - resembling a kind of sponge at nano level - can be generated in semiconductors.
Tyndall and Sanmina Corporation have announced a research collaboration, which will focus on the development of a novel wireless technology for a commercial wrist-worn health-monitoring platform.
When studying diseases or testing potential drug therapies, researchers usually turn to cultured cells on Petri dishes or experiments with lab animals, but recently, researchers have been developing a different approach: small, organ-on-a-chip devices that mimic the functions of human organs, serving as potentially cheaper and more effective tools.
Cells communicate with each other through a number of different mechanisms. Some of these mechanisms are well-known: in animals, for example, predatory threats can drive the release of norepinephrine, a hormone that travels through the bloodstream and triggers heart and muscle cells to initiate a "fight-or-flight" response.
Each year 40,000 babies in the U.S. are born with a congenital heart defect, often caused by a defective heart valve, which is estimated to account for 8,000 to 13,000 new cases in the U.S. alone.
A team of researchers at DGIST has recently developed a technology which enables to acquire a high resolution mass spectrometry imaging in micrometer size of live biological samples without chemical pretreatment in the general atmospheric pressure environment.
From clunky wristbands to restrictive chest straps, the first generation of wearables have been marred by user adoption challenges and impractical product design. That’s why Spire, the leaders in discreet and actionable health monitoring, set out to make the wearable as we know it disappear.
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.