FEATURED EDITORIAL

Boston Scientific’s Plan To Create Modular Pacing — A Chat With Dr. Ken Stein, SVP/CMO, Cardiac Rhythm Management
Boston Scientific’s Plan To Create Modular Pacing — A Chat With Dr. Ken Stein, SVP/CMO, Cardiac Rhythm Management

Med Device Online recently interviewed Dr. Ken Stein, SVP and chief medical officer at Boston Scientific CRM. Dr. Stein discussed his company’s yet-to-be-named, leadless micro pacer, where the device stands in development, and how Boston Scientific plans to combine its new pacing technology with its subcutaneous implantable defibrillator (S-ICD) to create a flexible modular system.

  • 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. 

  • Final FDA Human Factors Guidance: 10 Updates That Affect Your Validation
    Final FDA Human Factors Guidance: 10 Updates That Affect Your Validation

    FDA’s final human factors guidance expands upon the importance of incorporating a robust human factors approach throughout the design and development process, resulting in devices that are safe and usable for the intended user population in the intended use environment. Anyone planning to seek device approval through the 510(k) or PMA submission processes should note these 10 critical updates concerning device validation.

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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

Manifold Technologies and Techniques Manifold Technologies and Techniques

For over three decades, the Lee Company Electro-Fluidic Systems Group has been an industry leader in electromechanical valve and pump technology. Their expertise in fluidics is drawn from a complete understanding of the application and components involved. Using a manifold technique, it is possible to incorporate solenoid valves, pumps, passive components and active components into a complete assembly that has been functionally tested per the application requirements.

Insert Molding for Medical Devices Insert Molding for Medical Devices

Insert molding techniques can streamline the production of your next medical device and eliminate the need for additional secondary operations. This type of molding can result in consistency, stability, the potential for reduced size and weight, and design flexibility.

Cleanroom Injection Molding for Disposable Medical Devices Cleanroom Injection Molding for Disposable Medical Devices

Phase 2 Medical’s Rochester, NH location was recently outfitted with 2,500 sq. ft. ISO Class 8 (100,000) cleanroom facility with an injection molding press. This was done in an effort to integrate quality plastic components in their customers’ disposable medical devices.

OEM Tympanic Thermometer: Genius™ 2 OEM Tympanic Thermometer: Genius™ 2

Medtronic offers the Genius™ 2 OEM tethered OEM tympanic thermometer designed specifically for OEM integration. A developer’s kit contains all of the vital information needed to facilitate integration of the Genius™ 2 Tethered OEM Tympanic Thermometer into a multi-parameter device.

Ethylene Oxide (EO) Sterilization of Medical Devices

Ethylene Oxide (also known as EO or EtO) sterilization is a simple chemical compound that is commonly used for gaseous sterilization of disposable medical devices and healthcare products. A wide variety of materials and components commonly used in the manufacture of these products may undergo ethylene oxide sterilization in their final breathable packaging configuration.

Custom Packaging And Pouching Custom Packaging And Pouching

As demands in customer packaging and pouching grow in sophistication, ATL has kept pace by expanding our packaging capabilities. We have the engineering expertise to go beyond typical "cookie-cutter" type packaging modes in order to accommodate your one-stop supplier needs.

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FEATURED SUPPLIERS

Phase 2 Medical Manufacturing, Inc. Phase 2 Medical Manufacturing, Inc.

Phase 2 was founded in 1995 to focus exclusively on contract manufacturing of medical devices. We have grown from 5 people at our founding to over 150 associates in our organization today. We work with startup medical devices companies through large OEMs in getting products to market, design for manufacturability, and operational efficiency.

Corry Micronics, Inc. Corry Micronics, Inc.
Corry Micronics, located in northwestern Pennsylvania, has been producing Feedthru Capacitors and Radio-Frequency Interference (RFI) Filters since 1970...

DOUG'S LATEST COLUMNS

Doug's Latest Columns

LATEST HEADLINES

  • 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.

  • GE Reports Strong Performance Of Healthcare Unit
    GE Reports Strong Performance Of Healthcare Unit

    General Electric (GE) reported that its Healthcare business performed well in the first quarter of 2016, and expects the unit to continue growing for the rest of 2016. For the first three months of the year, Healthcare posted 15 percent growth, and had the best organic growth in 20 quarters, according to a Seeking Alpha transcript of the earnings call.

  • Zimmer Biomet Acquires Cayenne Medical, Boosts Sports Medicine Segment
    Zimmer Biomet Acquires Cayenne Medical, Boosts Sports Medicine Segment

    Zimmer Biomet has bolstered its sports medicine device segment with the acquisition of Cayenne Medical for an undisclosed amount. Senior executives from both companies commented that the deal will accelerate Cayenne’s portfolio of minimally invasive soft tissue and reconstruction solutions for extremities.

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