Beyond addressing an unmet medical need, diagnostics device makers serving the home point-of-care (POC) market must satisfy both the care provider and the patient if a product is to succeed. Add to that the challenge of keeping pace with the evolution of telehealth and mobile health platforms, and the uncertainty of new technology — specifically, that it doesn’t always deliver on its promise of a trouble-free solution.
Despite global medtech giants’ domination of India’s medical device industry and unfavorable domestic regulations, local startups hope to make lifesaving medical technology more accessible in a country where high-quality, affordable healthcare is scarce. Their products and ideas stand ready to impact markets across Africa, low-income countries in South America, Asia, and even Eastern Europe.
Medtech entrepreneurs need to think like their investors and structure their operations accordingly. Excessive spending without achieving the critical milestones will not be tolerated; nor will an overly restricted cash burn that leaves a project limping forward.
Historically, startups haven't gone through the entire product development process. They’ve done the heavy lifting with innovation and engineering, but are at a loss when it comes to navigating regulatory approval and figuring out how to successfully (and compliantly) commercialize. This is where value can be lost.
As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”
The industry must be able to demonstrate that it has been able to use the tax suspension to innovate and grow in order to avoid the tax’s reinstatement. The ability to show results will be paramount, creating a need for more efficient online reporting.
Radio frequency (RF) ablation uses RF energy to ablate or destroy unwanted tissues. When delivered via a catheter, it offers a minimally invasive treatment for a wide variety of conditions, including atrial fibrillation (AF). These systems typically include a peristaltic pump to provide cooling or temperature control, and this pump must be able to produce and control the high pressures (up to 130 psi) required in this application.
Shifts in healthcare have essentially changed suppliers’ role in the industry – especially when it comes to infection prevention. And, they’ve greatly impacted how both providers and suppliers think about the use of antimicrobials.
Labels often are an afterthought, because they don’t directly affect the capabilities of a medical device. However, they certainly affect the functionality of the device and users’ ability to effectively utilize all of its features. Consider these factors — and their importance — as you design your medical device overlay or inventory stickers.
Patient organizations and industry groups want the U.S. Food and Drug Administration (FDA) to clarify salient points in its draft guidance on how manufacturers should share patient-specific data with patients.
The FDA has for the first time cleared a computerized diagnostic device designed specifically to evaluate a patient’s cognitive function immediately following a head injury and a suspected traumatic brain injury (TBI), otherwise known as concussion. While the Immediate Post-Concussion Assessment and Cognitive Testing (imPACT) device cannot conclusively diagnose TBI on its own, or direct a course of treatment, the tool offers point-of-care quantitative evaluation to assist trained healthcare providers in making treatment decisions.
A new handheld device may better equip patients in their decision-making process when choosing an intraocular lens (IOL) implant. The SimVis, developed by Spanish scientists, was tested with cataract surgery candidates, and researchers found patients had a clear preference for certain implants based on their experiences with the device.
Engineers at the University of Washington (UW) have devised a new method of wireless communication that converts Bluetooth transmission from mobile devices into Wi-Fi signals. Using this "interscatter" communications technology allows medical devices and implants with limited power sources to gain the ability to send data using low-power Wi-Fi signals to smartphones and smartwatches.
The Advanced Medical Technology Association (AdvaMed), the Medical Device Manufacturers Association (MDMA), and Medical Imaging & Technology Alliance (MITA) recently announced that a tentative agreement has been reached with FDA to reauthorize the Medical Device User Fee Act, building on the progress from the 2012 user fee agreement to further improve the agency’s device review process while maintaining its robust standards for patient safety.
SeaSpine has acquired Israeli medtech NLT and its platform of minimally invasive fusion technologies for degenerative spine disease. SeaSpine CEO Keith Valentine remarked that the deal, potentially worth $52.5 million in cash and stock, marks the newly spun-off company’s commitment to innovation through acquisition.
Ethicon*, a trusted leader in advancing wound closure, announces the launch of STRATAFIX™ Spiral PDS Plus and STRATAFIX™ Spiral Monocryl Plus Knotless Tissue Control Devices.
Edwards Lifesciences has received from the U.S. Food and Drug Administration (FDA) expanded indication approvals for its Sapien 3 and Sapien XT transcatheter heart valves in intermediate-risk patients suffering from aortic valve stenosis. With the approval, Edwards brings significantly more patients into its captive transcatheter aortic valve replacement (TAVR) market, ahead of Medtronic and others.