Inspector General’s 2016 Work Plan: A Cybersecurity Wake-Up Call To Medical Device Designers
Inspector General’s 2016 Work Plan: A Cybersecurity Wake-Up Call To Medical Device Designers

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.

  • A Primer On Investigational Drug/Delivery Device Regulatory Requirements
    A Primer On Investigational Drug/Delivery Device Regulatory Requirements

    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 Device Innovation: Changing Current Treatment Algorithms
    Diabetes Device Innovation: Changing Current Treatment Algorithms

    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. 

  • Why Outsource Or Offshore Your Medtech Operations? (And How To Ensure A Smooth Transition)
    Why Outsource Or Offshore Your Medtech Operations? (And How To Ensure A Smooth Transition)

    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. 


  • Drug Delivery On The Go: Device Design Considerations

    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.

Enhancing Endoscopy With Optical Filters

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. 

Solvent Tube Bonding

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.

Benefits Of Using A Miniature, High-Pressure, High-Flow Liquid Valves In Laboratory OEM Instrumentation

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.

5 Factors To Consider When Choosing A CRO For Your Cardiovascular Clinical Trial

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.

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Extreme Precision Optics Group Extreme Precision Optics Group

Zygo’s extreme precision optics group provides services involving aspheric surface fabrication, computer controlled optical surfacing, ion beam figuring (IBF), precision glass machining, abrasive machining, and precision glass assembly.

Gamma Irradiation for Medical Devices

The STERIS Isomedix Services gamma sterilization process uses Cobalt 60 radiation to kill microorganisms on a variety of different medical devices. Processing with gamma yields quick turnaround time, easily penetrating packaging and product, and is ideal for many types of materials.

RF Radiated Immunity System: MT06000A RF Radiated Immunity System: MT06000A

AR’s Multistar is a multi-tone RF radiated immunity system covering the 65 MHz to 6 GHz frequency range. It’s a complete testing solution for the following standards: EN/IEC62000-4-3, EN/IEC60601-1-2, EN50130-4, EN61000-6-1/2, EN55024.

Micro Molding Medical Grade Materials Micro Molding Medical Grade Materials

ProMed offers micro molding services for both long-term and short-term implantable medical device components, making parts as small as .002g and shot sizes up to 3g. They have experience with a variety of medical-grade plastic materials (thermoplastics) such as EVA, PSU, PLA, PLGA, PEEK, Filled PEEK, and Ultem. They also work with Polycarbonate, ABS, and Pebax.

Micro Prisms Micro Prisms

Micro prisms have a minimum of two plano surfaces that are separated by a wedge angle. Precision Optics Corporation manufactures prisms as small as 0.18 mm to rotate, deflect, and deviate beams of light and disperse their wavelengths.

Bolt-In RFI Filters Bolt-In RFI Filters
These resin sealed filters are manufactured for installation into a threaded or thru-hole application. Filters are available in "C", "L" and "Pi" configurations and are available in various capacitances, voltages and sizes ranging from 2-56 to 1/4-28...
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SMC Ltd. SMC Ltd.

Passion for technology has driven SMC Ltd. to be a leading manufacturing partner to top medical OEM’s in the diagnostics, pharmaceutical and medical device markets. Services include program management, product launch/scale-up, product design, engineering, prototyping, strategic supply chain management, custom thermoplastics component manufacturing, assembly, reagent filling, pouching, pre-packaged drug handling, automation, testing, and packaging.

Promed Molded Products Inc. Promed Molded Products Inc.

ProMed was founded in 1989 to address an industry need for cleanroom molding of silicone components, primarily those having a medical application. The company has expanded its capabilities over the years and now offers silicone molding along with micro-molding of highly engineered plastics and drug eluting / combination products. From a single component to complete devices, ProMed has the resources, quality systems and facilities to meet most dimensional and cosmetic print specifications and comply with rigorous industry standards. 


  • FDA Warns Intravascular Device Coatings May Separate
    FDA Warns Intravascular Device Coatings May Separate

    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.

  • Boston Scientific’s Watchman Could Receive CED Reimbursement From CMS
    Boston Scientific’s Watchman Could Receive CED Reimbursement From CMS

    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 “Top Workplace” In Michigan

    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, Zebra Team On Analytics Platform And Data Management Tools

    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.

  • Allergan, Pfizer Merge In $160 Billion Tax Inversion Deal
    Allergan, Pfizer Merge In $160 Billion Tax Inversion Deal

    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. 

  • MIT’s Ingestible Device Measures Vital Signs Acoustically
    MIT’s Ingestible Device Measures Vital Signs Acoustically

    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 Introduces Subscription Model For App-Based Ultrasound
    Philips Introduces Subscription Model For App-Based Ultrasound

    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.

  • J&J's Biosense Acquires WaveCrest LAA Closure Device Developer
    J&J's Biosense Acquires WaveCrest LAA Closure Device Developer

    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.

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