If, as most believe, the future of the medical device industry will be determined by emerging markets, manufacturers need to embrace the idea of needs-driven local innovation for unmet medical needs.
Last week, we spoke with the CEO and founder of Biotricity, Waqaas Al-Siddiq, about physician concerns due to a lack of clear delineation between medical grade vs fitness/lifestyle devices. In Part 2 of my discussion with Al-Siddiq, we explore some of the trends and market evolutions that will affect the wearable device industry in the next five years.
The European market for hearing devices has experienced significant growth in recent years. In 2015, the market was valued at just over €7.2 billion. Included in our analysis are the markets for hearing aids, hearing aid batteries, cochlear implants, and bone-anchored hearing aids.
As hospitals and health systems grapple with value-based payments and new quality requirements, medical device and diagnostic companies are serving as enablers, reaching across the healthcare ecosystem to offer services that engage patients in real time, improve physician performance, and demonstrate value beyond any one device, diagnostic, or technology. Both established medtech players and newer entrants should consider these four factors when designing their offerings and contracting with customers:
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.
The National Institute of Health has awarded a $2.3 million grant to CivaTech, developer of an implantable device that provides targeted radiation treatment for cancer patients. CivaTech plans to use the grant to fund a clinical study that will evaluate safety and efficacy of the CivaSheet device in patients with pancreatic cancer.
A Planning Board convened by the U.S. Food and Drug Administration (FDA) and the Duke-Margolis Center for Health Policy laid out the initial priorities for the proposed Coordinating Center in charge of the National Evaluation System for Health Technology (NEST).
Orthopaedic products manufacturer Zimmer Biomet has unveiled Vanguard Individualized Design (ID), which is touted as a first-of-its-kind total knee arthroplasty (TKA) personalized construct, with dual bearings to better preserve the natural tissues surrounding the knee joint.
FDA has published a draft guidance for industry outlining the agency’s approach to the coordinated development of antimicrobial drugs and antimicrobial susceptibility test (AST) devices. Though the agency wishes to better facilitate interactions between drug sponsors and device developers, FDA emphasized that applications will remain separate, and review timelines for separate products will not be influenced by each other.
Bayer announced that the U.S. Food and Drug Administration (FDA) has approved the company's newest intrauterine device (IUD), Kyleena (levonorgestrel-releasing intrauterine system) 19.5 mg, for the reversible, long-acting prevention of pregnancy for up to five years.
Johnson & Johnson (J&J) subsidiary Acclarent announced that the FDA has awarded de novo approval to its balloon dilation system, the Aera System, which joins J&J’s portfolio of minimally invasive therapies for ear, nose, and throat (ENT) conditions. Aera is indicated for the treatment of persistent eustachian tube dysfunction (ETD).
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the launch of its next generation wireless rapid diagnostic system for detection of influenza A and B, respiratory syncytial virus (RSV) and group A strep, with new traceability and secure patient health record documentation features and functionality.
SynCardia Systems, LLC (“SynCardia” or the “Company”), maker of the SynCardia temporary Total Artificial Heart (TAH-t), recently successfully completed its previously announced reorganization process and has been acquired by affiliates of investment firm Versa Capital Management, LLC (“Versa”).