FEATURED EDITORIAL

How To Plan For The EU’s New In Vitro Diagnostic Regulations
How To Plan For The EU’s New In Vitro Diagnostic Regulations

A new In Vitro Diagnostic Devices Regulation (IVDR) has been proposed to replace the existing In Vitro Diagnostic Devices Directive. Mapping out your path ahead of time, including preparing to be flexible, will equip you to respond to this new paradigm.

  • 6 Rules To Effectively Implement A Compliant UDI Program
    6 Rules To Effectively Implement A Compliant UDI Program

    The first and second Unique Device Identification (UDI) compliance dates have passed, and successfully understanding the difference between the “letter of the law” and the “spirit of the law” not only ensures compliance, but also determines that your UDI solution was right for your firm. Here are several key considerations for firms embarking on a UDI compliance program for Class I and II devices.

  • Insiders’ Guide To Winning In the Drug Delivery Device Market — Part 5: The Internet of Things
    Insiders’ Guide To Winning In the Drug Delivery Device Market — Part 5: The Internet of Things

    To learn more about how the IoT will impact medtech as a whole, and drug delivery in particular, I interviewed Stephen Wilcox, principal and founder of Design Science, Inc. We discussed his thoughts on trends in the drug delivery device market, how he sees the evolution of the IoT transforming healthcare technology, and what implications the technology holds for device developers.

  • A Comprehensive Guide To The U.S. TAVR Market: Looking Ahead
    A Comprehensive Guide To The U.S. TAVR Market: Looking Ahead

    The second article in a two-part series examining the past, present, and future of the U.S. transcatheter aortic valve replacement (TAVR) market, this installment examines what it will take for TAVRs to become the standard of care for low-, intermediate-, and high-risk patients with severe symptomatic aortic stenosis. It also looks at major competitors in the space and emerging opportunities. 

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INDUSTRY INSIGHTS

  • Understanding The Types Of Sterilization For Medical Device Components

    In order to better understand the different types of sterilization for medical device components we refer to the Center for Disease Control and Prevention for a definition; "sterilization is the use of a physical or chemical process that destroys all microbial life including the bacterial endospores that are so highly resistant". By Rena Ivory, Crescent Industries, Inc.

The Role Of Zeta Potential In The Manufacture Of Healthcare Materials

In the manufacture of healthcare products and medical materials, especially ceramic materials like zirconia (used as an implant material) and hydroxyapatite (synthetic bone replacement material), there is often a stage in the manufacturing process involving a powder suspension. By Matthew Cantelo, Lucideon

Medical Device Clinical Trials – How Do They Compare With Drug Trials?

It seems like the clinical research world is often thought of in terms of pharmaceuticals. Clinical trials are often referred to in Phases, such as “a Phase 2 study of a new drug” or “a Phase 3 randomized clinical study with a placebo control.” By Brandy Chittester, IMARC Research, Inc. 

Human-Centred Design And Inhalation Device Development

Human-centred designs have become a driving trend in the development of next-generation inhalation devices, making them more useful, usable, and desirable than current inhalation devices. By applying design research, industrial research, and human factor disciplines in cooperation with design for manufacturing and assembly philosophy, patients are able to receive inhalation devices that minimize opportunities for error, and support greater adherence to their prescribed therapy.

This white paper describes Phillips-Medisize’s approach to human-centered design in producing the next generation of smaller and smarter inhalation devices.

3 Tips For Specifying Silicone Tolerances

The best part of my job is helping medical device manufacturers use molded silicone components in their innovations. By Phil LaRoy, Vesta

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SOLUTIONS

Wavelength-Sensitive Photodiodes- WS Series Wavelength-Sensitive Photodiodes- WS Series

Wavelength-sensitive photodiodes utilize the effect of the wavelength-specific absorption depth of radiation in silicon. First Sensor wavelength sensitive photodiodes are unique photo detectors with two vertically stacked p-n junctions in the single silicon crystal. One junction is enhanced for blue sensitivity and the other is enhanced for red sensitivity. Such a configuration is particularly useful for the wavelength detection of monochromatic input signals.

Electrospun Polymer Solutions For Controlled Biological Interaction: Bioweb™ Technology Electrospun Polymer Solutions For Controlled Biological Interaction: Bioweb™ Technology

Zeus offers Bioweb™ electrospinning technology that produces polymer fiber solutions with thickness ranging from nanoscale to microscale sizes. These fibers can be used to electrospin fabrics with complex shapes, and produce a broad range of fiber and fabric properties. Possible solutions include encapsulation technology, spin membranes/sheets, and 3-D structures for coating substrates of varying shapes and sizes.

Scientific Molding Scientific Molding

PTI’s scientific injection molding services are ideal for the manufacture of medical devices because of the four process parameters monitored during production. They are plastic temperature, injection velocity, plastic pressure, and tool temperature.

Assembly And Packaging Assembly And Packaging

Assembly, packaging and sterilization for critical medical devices are vital processes that Donatelle performs with unparalleled rigor and skill. Options are available to choose from white room, ISO 7 (class 10,000) or ISO 8 (class 100,000) cleanroom assembly and packaging, in Donatelle’s vertically integrated facility.

Entry-Level Infrared Cameras For Research And Science Applications Entry-Level Infrared Cameras For Research And Science Applications

These infrared cameras for research and science applications offer image quality, ease of use, and accurate temperature measurement, all with a low cost. They’re available in handheld and fixed mount configurations, and feature thermal sensitivity up to 50 mK, temperature measurement up to 2,000° C, flexible optics for close-up and distance imaging, and more. Engineers that work in general medical and bioresearch applications, as well as researches involved with universities, power conversion, the electronics industry, and solar cell development can benefit from the use of FLIR’s entry-level Infrared Cameras. This line starts at under $10,000.

Quality Management Systems for Medical Devices Quality Management Systems for Medical Devices

With their sole focus on being a contract manufacturer of medical devices, Phase 2’s Quality Management System (QMS) has helped to establish the company as a provider of quality medical devices manufactured in a lean production environment.

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FEATURED SUPPLIERS

Zeus Zeus

We were among the first to work in the arena of minimally invasive techniques for revolutionary procedures such as neuromodulation. Our PEEK drawn fiber offers a non-metallic replacement for stainless steel. And when a major aircraft manufacturer needed an immediate design change on a harness assembly, Zeus delivered in record time.

Alconox, Inc. Alconox, Inc.

With more than 60 years of experience in formulation of quality aqueous cleaners, Alconox Inc. understands the cleaning needs of the medical device manufacturing industry including stringent FDA regulations and GMP compliance.

DOUG'S LATEST COLUMNS

Doug's Latest Columns

LATEST HEADLINES

  • Abbott Pays $25 Billion For St. Jude Medical To Boost Device Business
    Abbott Pays $25 Billion For St. Jude Medical To Boost Device Business

    Abbott will acquire St. Jude Medical for $25 billion in cash and stock to significantly enhance its medical device business and cope with increasing price pressure from consolidating hospital clients.

  • CEO Touts Dexcom’s Diabetes Management Success, Says CGM Launch With Verily “On Track” For 2018
    CEO Touts Dexcom’s Diabetes Management Success, Says CGM Launch With Verily “On Track” For 2018

    Dexcom CEO Kevin Sayer spoke candidly about his organization’s recent growth and the associated “growing pains” as he laid out the company’s strategy moving forward. Despite what he calls the “most complicated product launch in our history” — the G5 continuous glucose monitor (CGM) —  Sayer reported a 60 percent bump in Q1 diabetes management system revenue, gleaned by far outperforming market competitors, including Medtronic, J&J, and Abbott.

  • Edwards Lifesciences Rides Momentum In TAVR
    Edwards Lifesciences Rides Momentum In TAVR

    Building on a strong showing during the preceding quarter, and based on increased adoption in the United States, transcatheter heart valve (THV) therapies drove up first quarter sales of Edwards Lifesciences, the company announced recently.

  • New Products, Emerging Markets Power Boston Scientific’s Best Quarterly Performance In A Decade
    New Products, Emerging Markets Power Boston Scientific’s Best Quarterly Performance In A Decade

    Boston Scientific has achieved double-digit growth in four of its seven businesses for a total of 11 percent Q1 growth overall, its best quarterly performance in over a decade, according to senior executives. Analysts attribute the growth in part to the company’s ability to diversify in lesser known markets and the successful launch of several new products.

  • Philips' HealthTech Unit Fuels Q1 Sales Growth
    Philips' HealthTech Unit Fuels Q1 Sales Growth

    Royal Philips is starting to reap positive results from its strategic pivot into healthcare, with its HealthTech business expanding by 5 percent during the first quarter, helping drive comparable sales growth up 3 percent to €5.5 billion. Continued investments, deal-making, and product launches contributed to the strong performance of the unit, which will be the sole focus for the company after it sells its Lighting business.

  • Elekta Touts MR-Guided Linear Reactor At ESTRO 35

    Elekta today announced that its leading-edge high-field MR-guided linear accelerator (MR-linac) platform will be the focal point of seven scientific presentations at ESTRO 35, the annual meeting of the European Society for Radiotherapy & Oncology, taking place April 29 - May 3.

  • Stryker Launching Joint Replacement Patient Program To Support Value-Based Care

    Stryker's Performance Solutions (SPS), the business unit of Stryker's Reconstructive Division that partners with hospitals and physician practices to improve quality outcomes, patient satisfaction and profitability in the orthopedic segment, is launching a new digital patient engagement and education platform to help improve the overall care delivery and experience for patients undergoing joint replacement surgery.

  • Baxter Reports Strong Q1 Growth, Hints At Innovative Pipeline
    Baxter Reports Strong Q1 Growth, Hints At Innovative Pipeline

    Baxter CEO Jose Almeida — the former CEO of Covidien — is making good on his promises to drive growth by cutting costs and investing in innovation, as the company announced a worldwide 4 percent increase in revenues in the first quarter of 2016. Baxter also will host an innovation hall at its 2016 Investor Conference, which will showcase the company’s recent R&D efforts.

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