The U.S. Department of Health and Human Services (HHS) Office of Inspector General’s (OIG) Work Plan for 2016 summarizes OIG’s efforts to improve the overall effectiveness of more than 100 programs administered by HHS. In addition to scrutinizing Centers for Medicare & Medicaid Services (CMS) reimbursement for fraud and cost-cutting opportunities, OIG will put medtech cybersecurity under the microscope.
Combination drug/device delivery products are becoming the standard of care in many therapeutic areas, but a cloud of confusion persists surrounding investigational products: What are the requirements for drug/delivery devices used in clinical trials?
Diabetes affected almost 9 percent of adults globally in 2014. The prevalence of the condition results in a very large market for both drug delivery and diabetes-monitoring devices, and there is room for improvement in the treatment and management of the disease. Here, I will discuss two innovations which, upon release, will help address some of the shortcomings associated with current diabetes treatments options.
In this article series, we will explore the latest trends, challenges, and best practices surrounding outsourcing and offshoring in the medical device industry. This first installment will explain the benefits of outsourcing and offshoring, and share some tips for making the transition process as smooth as possible for you and your organization.
Wearable devices are changing the world of drug delivery, emerging as solutions for chronic disease management and offering patients reprieve from the burden associated with frequent injections and bulky ambulatory devices. This article details some of the design considerations that manufacturers must make when creating next-generation drug-delivery wearables.
Endoscopic examination is a key technique used to diagnose early-stage neoplastic lesions associated with stomach and other gastrointestinal cancers. While white-light reflectance (WLR) imaging has become the standard for in vivo diagnosis using “conventional endoscopy,” this white paper details three alternatives - or supplements - to WLR that leverage the wavelength selectivity provided by optical filters: narrow-band imaging (NBI), auto-fluorescence imaging (AFI), and endoscopic Raman spectroscopy.
As medical devices become more sophisticated and complex in performance and structural complexity, solvent bonding is used in making permanent connections within plastic part assemblies. This method can dramatically reduce costs while producing aesthetically pleasing joints with low weight and sufficiently strong connections. The process of bonding medical components involves a thorough understanding of the design process, material compatibility, performance testing, assembly methods, and regulatory affairs.
Parker Hannifin has designed the next generation of liquid handling products and solutions which includes a large array of liquid valves, liquid pumps, pneumatic valves and pumps, and syringe pumps. Advancements in liquid valve capabilities enable more innovative devices that are significantly smaller, can work under higher pressure differentials, and enable a large reduction of reagent consumed for each sample to be tested. This article discusses how valve manufacturers are designing and producing liquid valve technologies to help meet OEM challenges.
Clinical trials conducted in the Cardiovascular (CV) arena are challenging, first and foremost, due to the variety of underlying disease states and conditions that affect a majority of potential trial participants.
The U.S. Food and Drug Administration (FDA) has issued a safety communication warning physicians that hydrophilic and/or hydrophobic coatings on several types of intravascular medical devices could separate and cause serious injury or death to patients.
Despite issuing a proposal last week that would limit access to Boston Scientific’s Watchman, the Centers for Medicare and Medicaid Services (CMS) now has suggested the creation of a registry that would provide coverage for Medicare and Medicaid patients participating in an approved clinical study of similar devices.
PTI Engineered Plastics, an industry leader in tooling and injection molding, was honored to make the list of “Top 100 Workplaces” in Michigan. This distinction was based on employee feedback in a survey conducted by Workplace Dynamics, on behalf of the Detroit Free Press newspaper.
Dell Services has signed a multi-year agreement with Zebra Medical Vision to deliver a world-class platform for medical imaging research that integrates with theDell Cloud Clinical Archive, which currently hosts more than 10 billion medical images and 150 million medical studies.
United States-based Pfizer Inc. is set to merge with Ireland-based Allergan plc in a transaction worth $160 billion. The combined firm would be renamed Pfizer plc and transfer its tax domicile in Ireland. Because the combined portfolio of the two companies is expansive, executives of both companies already are considering splitting the combined company into two no later than 2018.
Scientists at MIT have developed an ingestible device that can collect acoustic data and translate it into heart rates and lung sounds. Their proposed system is an alternative to wearable monitoring equipment, which can be cumbersome for patients, particularly trauma victims.
Philips has introduced Lumify, an ultrasound transducer that plugs into commercially available Android smart devices and tablets, part of a holistic ultrasound solution which includes a mobile app, access to an online portal, a warranty, and integrated IT and support services. Philips plans to distribute the system using a flexible subscription model.
Johnson & Johnson subsidiary Biosense Webster has purchased Coherex Medical, maker of the WaveCrest left atrial appendage (LAA) occlusion device for the treatment of high-risk atrial fibrillation (AF), for an unspecified amount.