As medical devices and procedures become more reliant on computers and technology, the question of whether a patent is directed to a patent-ineligible abstract idea becomes increasingly relevant. Thus, it is important for the medical device community to understand how to claim their innovations in a way that passes Mayo/Alice muster.
A draft version of the new European Medical Device Regulations (MDR) recently was released, and it stipulates that UDI codes must be included on all medical device labels. Now is a crucial time for European manufacturers to look at how exactly U.S. manufacturers implemented UDI and what, specifically, the European manufacturers can learn from them.
This article demonstrates two methods using the success-run theorem, which uses the confidence level (how sure we are) and reliability value (valid, consistent results) to determine appropriate statistically valid sample sizes for process validation.
Due to critical differences in economic conditions — and unique unmet needs in the Indian market — what works well in the West may not succeed in India. While India’s medical devices and equipment market is growing strongly, a variety of factors specific to that market are impacting the performance of each product type.
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.
In the race to bring innovative products to market, ensuring a seamless transition from design to manufacturing is critical. Yet, in today’s marketplace, design and manufacturing engineers alike are faced with many new challenges.
Looking at the rising trend towards self-administration therapies, injectable drug delivery devices such as pen injectors, autoinjectors and needle free injectors show a significant growth potential in the near future.
Boston Scientific credits its “category leadership strategy” for the company’s staggering 27 percent net income growth in the second quarter of 2016. CEO Mike Mahoney commented that Boston Scientific is aiming for “as much financial flexibility as we can have” and is on track to sustain momentum in its cardiac rhythm management business (CRM), which had lagged due to a lack of MRI-compatible products.
Final guidance from the U.S. Food and Drug Administration (FDA) for staff and sponsors lays out how to plan and implement adaptive designs for clinical studies when used in medical device development programs and submissions for Premarket Approval Applications (PMA), premarket notification (510(k)) submissions, de novo submissions (Evaluation of Automatic Class III Designation), Humanitarian Device Exemption (HDE) applications and Investigational Device Exemption (IDE).
Baxter achieved better-than-expected second quarter sales and significant growth in its hospital products business. CEO José Almeida reported that the company is on track with its strategy outlined earlier this year, with continued growth resulting from a “disciplined focus” on portfolio management, innovation, and capital allocation for M&A.
The U.S. Food and Drug Administration (FDA) has issued draft guidance that clarifies how it intends to evaluate real-world evidence (RWE) to support regulatory decisions.
Following the successful listing of its lighting business on the Euronext Amsterdam Stock Exchange in May, Royal Philips can now focus squarely on its HealthTech business, according to its chief executive.
Zimmer Biomet announced its plans to leverage the company’s years of consulting experience with its cultivated portfolio of technologies and analytical tools to create an “end-to-end” suite of clinical services called Signature Solutions. The intent of the service is to drive greater efficiency and improve patient outcomes in hospitals while working with the hospitals’ existing infrastructure.
Boston Scientific Corporation (NYSE: BSX) today announced that it has acquired Cosman Medical, Inc., a privately held Burlington, Mass. manufacturer of radiofrequency ablation (RFA) systems.
Taking inspiration from bacteria, a team of Swiss scientists has developed a platform for developing microrobots that can be customized for various medical indications, such as delivering drugs or performing delicate surgical operations, including unblocking clogged arteries. These tiny robots shapeshift in response to heat and can be remotely controlled using electromagnetic fields.