The process of material selection often begins by evaluating the characteristics of a given polymer family, and comparing and contrasting them with the characteristics of other polymer families. This evaluation is done in concert with a thorough review of the performance requirements of the device.
The MEDDEV guidance 2.71, revised by the European Commission this year, instructs manufacturers how to properly conduct a clinical evaluation, including demonstration of the scientific validity of data and conclusions. The document also covers requirements specifically for postmarket surveillance and postmarket clinical follow-up.
Donald Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn about the agency, to help facilitate the transition from the Obama administration to the Trump administration. In this article, I describe what I expect the nascent 2017 agenda will be as Trump’s team walks in the door, and I offer a few thoughts as to why the Trump team would do well to consider the unique nature of FDA as transition planning takes shape.
Medical device interconnectivity has obvious benefits, but it also introduces new cyber-attack vectors for hackers to insert malware, compromise connected technologies, steal patient data, or even jeopardize patient health. The current state of medical device cyber readiness and compliance requires an immediate, industrywide call to action
Often, an already-approved drug can further benefit patients when applied with a medical device. In such cases, the pharmaceutical product sponsor may utilize the 505(b)(2) pathway for regulatory approval of the combination product. But even when the regulatory pathway is known, submission strategies for regulatory approval of combination products can be challenging and confusing. The development and review of combination products in the U.S. typically requires the involvement of multiple centers within the Food and Drug Administration (FDA), under the oversight of the FDA’s Office of Combination Products (OCP).
To enter the rapidly growing mobile health space, companies must overcome the Mobile Health Development-crucial hurdle of validation. This process demonstrates that the app – in combination with the underlying technology platform / device – performs comparably to traditional products on the market, ensuring that patients and providers can rely on the output to make appropriate medical decisions.
Winning in the medical devices market of the future requires mastering advanced technologies – or finding a partner with these capabilities. The global Internet of Things (IoT) in healthcare market is forecasted to reach $410 billion by 2022. To succeed in this arena, device companies need to stay out in front of manufacturing innovations so they can quickly integrate information technology (IT) functionality into their products, accelerate time to market and control costs.
The best practice for fitting multiple parts into a single assembly at tight tolerances is to choose a single component supplier with a sufficient array of core competencies in advanced device manufacturing methods. The chosen supplier should also utilize a well-designed component management process that includes close attention to important elements, proper planning, and high performance levels to provide an affordable, highly scalable drug delivery device.
The in vitro diagnostics (IVD) market is commonly segmented by techniques, products, application, end users, and geography. To better navigate the IVD diagnostic market landscape, understanding and recognizing how each segment is distinct, yet related to one another is critical for the company that wants to optimize its opportunities within this market.
Boston Scientific continues to diversify its foothold in the cardiovascular space, signing a definitive agreement to acquire select technologies and manufacturing capabilities from Neovasc, a Canadian biological tissue business specializing in elements used to build transcatheter heart valves.
The European Diagnostic Manufacturers Association (EDMA) and the European Medical Device Manufacturers Association (Eucomed) have formally integrated into a single entity called MedTech Europe effective immediately. It's the culmination of four years of close collaboration between the two associations, which are now dissolved.
Flexan Medical Holdings, LLC, a leading global custom rubber molding company, announced today the acquisition of Medron Inc, a medical device contract manufacturing services company. This acquisition supports the current trend of the medical device industry’s strategic efforts to outsource with total solution providers who can consolidate critical offerings to address the needs of the global device market.
The U.S. House of Representatives overwhelmingly passed a compromise version of the 21st Century Cures Act to streamline drug and medical device approval, and to boost research and medical innovation. The landmark legislation is headed next week to the Senate, where approval is seen likely.
President-elect Donald Trump has nominated U.S. Rep. Tom Price (R-GA.) as secretary of the Department of Health and Human Services (HHS), and tabbed Seema Verma, a healthcare consultant, to head the Centers for Medicare and Medicaid Services (CMS).
Medtronic has inked an Integrated Health Solutions agreement with University Hospitals Cleveland Medical Center (UH), the first agreement of its kind signed by Medtronic in the U.S. Together, the organizations will implement Medtronic’s operational models to streamline workflow and efficiency in select catherization (cath) and electrophysiology (EP) laboratories.
The U.S. Food and Drug Administration (FDA) has released guidance recommending mitigation strategies to reduce the risk of cross-contamination from irrigation tubing and accessories that are part of a flexible gastrointestinal endoscope system.
For the first time, scientists have generated lasers from the interaction of light and water waves. This "water-wave" laser can find future application in optofluidic devices and "lab-on-a-chip” devices for studying cell biology and delivering drugs at the nanoscale.