LEAD STORIES

GE, Temple University Health Center Ink Risk-Sharing Collaboration

GE Healthcare has signed a seven-year agreement with the Temple University Health System (TUHS) that is expected to provide the latter’s hospitals with the latest in high-quality radiologic imaging equipment, and to save TUHS over $39 million in operational costs. In the growing trend of risk-sharing collaborations among medtech companies and hospitals, GE is the first device manufacturer that has signed with an academic health system.

  • FDA Approves Dexcom’s Fully Mobile G5 CGM System
    FDA Approves Dexcom’s Fully Mobile G5 CGM System

    Five months after the launch of Dexcom’s G4 Mobile Continuous Glucose Monitoring (CGM) System, the FDA has approved Dexcom’s newest model, the G5, which boasts a transmitter with wireless Bluetooth technology and can communicate with iOS-enabled devices without an additional receiver.  Dexcom announced that patients who had received the G4 model after the beginning of August would be eligible for a free upgrade to the new model.

  • Google Life Sciences Becomes Standalone Company Under Alphabet
    Google Life Sciences Becomes Standalone Company Under Alphabet

    Signaling a deeper dive into medtech and healthcare, the life sciences unit under Google X R&D division will be spun-off into a standalone company under the newly-created Alphabet umbrella, according to Google co-founder and Alphabet president Sergey Brin.

INDUSTRY PERSPECTIVES

  • An Introduction To FDA And FCC Regulations Impacting mHealth
    An Introduction To FDA And FCC Regulations Impacting mHealth

    The world of mobile health, or mHealth — the practice of medicine and public health supported by mobile devices — is continually changing due to the innovative nature of the industry and to the regulatory scheme in place to monitor it, ensuring both patient safety and appropriate consumer access. While recent moves by the FDA have been welcome news to an industry that has requested more regulatory transparency, Federal Communications Commission (FCC) action in the “net neutrality” proceeding has introduced some new risk and uncertainty. 

  • How To Incorporate Risk Management In Medtech Supplier Quality Management, Part 2
    How To Incorporate Risk Management In Medtech Supplier Quality Management, Part 2

    In Part 1 of this series, we discussed developing a risk management strategy for supplier evaluation, along with a qualification plan to demonstrate compliance to auditors/regulators. In this article, I will share best practices for implementing a successful risk-based supplier management system, as well as explain the requirements that should be clearly defined in a supplier quality agreement.

  • Value Stream Mapping For Medical Device Companies, Part 2
    Value Stream Mapping For Medical Device Companies, Part 2

    In this edition of Thinking Lean, we are going to complete our two-part series on value stream mapping. In the part one of the series, we addressed the concepts of value stream identification and current state mapping.  In this article, we will talk about mapping the future state and creating a value stream plan.

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FROM THE EDITOR

  • Unhealthy Healthcare Economics: Medtech Innovation As The Cure, Not The Cause
    Unhealthy Healthcare Economics: Medtech Innovation As The Cure, Not The Cause

    The U.S. is on track to spend about $3.2 trillion in healthcare in 2015 (more than the entire GDP of France), and a projected $5.5. trillion by 2024. Yet, life expectancy in the U.S. is actually lower than in countries spending far less. It’s too early to say whether systemic improvements like the Affordable Care Act will be able to reverse this trend, but while we wait around to find out, medical technology has become a popular target for criticism and proposed spending cuts. What if the way out of this mess was to devote more resources to medical technology, not less?

  • Stryker’s MAKO Surgical Acquisition: A Second Look
    Stryker’s MAKO Surgical Acquisition: A Second Look

    At a time everyone was playing follow-the-leader in consolidation, Stryker took a different approach. With the MAKO acquisition, Stryker was bold enough to sacrifice short-term profit for long-term gain. I talked with Stuart Simpson, VP and GM of Stryker Reconstructive Business, about how that gamble could pay off.

  • Philips Healthcare: A New Approach To Innovation
    Philips Healthcare: A New Approach To Innovation

    How can well-established med device companies overcome the internal hurdles that prevent disruptive innovation? It is not a complete lack of structure that promotes optimal innovation. Just loosen the reins. I had the chance to discuss this topic with Ken Berta of Philips Healthcare. Berta works under the Philips Group Innovation umbrella and is the Head of Commercial Operations, North America.

More From The Editor

WHITE PAPERS & CASE STUDIES

  • CYA 101: 4 Tips to Help You Cover Your Audit
    CYA 101: 4 Tips to Help You Cover Your Audit

    Audits are a part of doing business for most life sciences companies, but that doesn’t make them any less stressful. If an audit goes badly, it’s a black eye for your company. You could be looking at long product delays, warning letters, consent decrees, recalls, or even a plant shutdown. So, what’s the secret to walking into an audit with confidence? It takes proper planning and the right tools. Here are a few tips to help you be better prepared, so you no longer have to fear the auditor.

Medical Extrusion — Finding The Right Sourcing Partner

In the medical field, extrusion is rapidly becoming more and more popular. Unfortunately, with the advances in medical device technologies, products and extrusion requirements are also becoming increasingly complex and demanding.

Turning To Lathe For Parts With Cylindrical Features

Does your next medical device have cylindrical features? If so, this white paper is for you. Download it to learn how adding a live-tool equipped CNC turning center to an already extensive three-axis milling service can product a better finish on cylindrical features, typically at a lower cost.

5 Practices For Managing Change When ISO 9001:2015 Arrives

Quality management system (QMS) standard ISO 9001:2008 is about to undergo some significant changes soon, with the new ISO 9001:2015 due to be published later this year. As a result of proposed fundamental changes to the structure and contents of the standard, this revision will be important to organizations with, or seeking, ISO 9001 certification and those implementing ISO 9001 systems.

Megatrends Impacting Designs Of Robotics In Life Sciences

There are three megatrends that are rapidly driving changes in the design and use of laboratory automation and robotics. This white paper discusses in-depth how demographic shifts, technology advancements, and commercial realities make their impact in life sciences.

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PRODUCT SHOWCASE

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.

Solujet: Low-Foaming Phosphate-Free Liquid Detergent

Solujet: Low-Foaming Phosphate-Free Liquid Detergent

Concentrated to save you money. Phosphate-free, biodegradable and readily disposable. Low foaming high wetting detergent for maximum performance. Free rinsing to give you reliable results and no interfering residues. Ideal for CIP cleaning and floor standing lab washing machines.
Rapid Technology Systems

Rapid Technology Systems

Carclo's Rapid Technology Systems (RTS) was designed to provide an integrated process to their customers. By providing earlier involvement than the typical prototyping service, RTS enables greater synergy in the design and development process.

Lab Testing and Sterilization Validation Services

Lab Testing and Sterilization Validation Services

REVOX has put together a team comprised of engineers, chemists, microbiologists, project managers, business consultants, and quality and regulatory professionals that are subject matter experts with strong expertise and experience in their fields. With such a team, REVOX can work to enable their sterilization technology to work to its fullest potential for medical devices. The company offers rapid 30-day sterilization development, materials and microbiological laboratory testing, supply chain optimization services, and regulatory development expertise.

As with any sterilization method, the REVOX room temperature PAA sterilization process must prove sterility using one of two testing methods—the overkill method or the bioburden method.  

Rapid Medical Device Prototyping

Rapid Medical Device Prototyping

ProMed sets themselves apart from other silicone molding contract manufacturers by eschewing popular 3D printing techniques that create prototypes made from similar materials to what the end result will actually be. Instead, they leverage their Rapid Prototype Development Department to offer their medical device manufacturing customers molded parts using the specified, final material in less than one business week.

Design and Development of Advanced Optical Applications

Design and Development of Advanced Optical Applications

Precision Optics Corporation, or POC, was formed over 30 years ago with the purpose of designing, developing, and realizing advanced optical applications and for volume production of specialized medical optical systems.

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LATEST HEADLINES

  • Greatbatch Pays $1.7B For Lake Region Medical

    Greatbatch, Inc. has announced that it will acquire Lake Region Medical for approximately $1.73 billion in cash and stock, a transformative deal that will create one of the largest medical device OEM suppliers in the world serving the cardiac, neuromodulation, vascular, orthopaedics and advanced surgical markets.

  • GE, Temple University Health Center Ink Risk-Sharing Collaboration
    GE, Temple University Health Center Ink Risk-Sharing Collaboration

    GE Healthcare has signed a seven-year agreement with the Temple University Health System (TUHS) that is expected to provide the latter’s hospitals with the latest in high-quality radiologic imaging equipment, and to save TUHS over $39 million in operational costs. In the growing trend of risk-sharing collaborations among medtech companies and hospitals, GE is the first device manufacturer that has signed with an academic health system.

  • FDA Task Force Proposes Coordinated Registries For National Medical Device Evaluation System
    FDA Task Force Proposes Coordinated Registries For National Medical Device Evaluation System

    A task force commissioned by the U.S. Food and Drug Administration Center for Devices and Radiologic Health (CDRH) is proposing a national medical device evaluation system based on coordinated registry networks (CRN) that would pool real-world device data from disparate sources into a single reference for patients, physicians, payers, manufacturers, and regulators.

  • Bristol Instruments Introduces The Fastest Wavelength Measurement For WDM Testing Applications
    Bristol Instruments Introduces The Fastest Wavelength Measurement For WDM Testing Applications

    Bristol Instruments, Inc. has set a new standard for WDM wavelength testing with the introduction of the 828B Optical Wavelength Meter. The new 828B model provides reliable accuracy at a rate that is 100 times faster than any other system available.

  • Medtronic Pays $458 Million For Mitral Valve Device Developer Twelve
    Medtronic Pays $458 Million For Mitral Valve Device Developer Twelve

    Medtronic has announced the acquisition of Twelve, Inc., a privately-held developer of a transcatheter mitral valve replacement (TMVR) device for the treatment of mitral regurgitation. The deal allows Medtronic to keep pace with rivals in the burgeoning transcatheter valve replacement device segment. Medtronic will pay $408 million at closing, plus a $50 million milestone payment, and Twelve will join the Coronary & Structural Heart division within Medtronic's Cardiac and Vascular Group.

  • FDA Approves Dexcom’s Fully Mobile G5 CGM System
    FDA Approves Dexcom’s Fully Mobile G5 CGM System

    Five months after the launch of Dexcom’s G4 Mobile Continuous Glucose Monitoring (CGM) System, the FDA has approved Dexcom’s newest model, the G5, which boasts a transmitter with wireless Bluetooth technology and can communicate with iOS-enabled devices without an additional receiver.  Dexcom announced that patients who had received the G4 model after the beginning of August would be eligible for a free upgrade to the new model.

  • NuVasive To Significantly Expand Manufacturing

    NuVasive, Inc. has announced that it intends to expand its manufacturing capabilities to meet growing demand for NuVasive’s spine technology and is actively exploring locations to build a new state-of-the-art medical device facility for its spinal implant and instrument manufacturing.  This new facility will support the Company’s efforts to increase the amount of products it internally manufactures, and enhance its focus on operational excellence and efforts to drive accelerated operating margin expansion.

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UPCOMING TRAINING COURSES

Monitoring Electronic Health Records (EHRs): Frequently Asked Questions

September 9, 2015
1pm-2:30pm EDT, Online Training

Laboratory Data Integrity: Current Expectations for OOS Result Investigations

September 16, 2015
1pm-2:30pm EDT, Online Training

Communication With FDA: What Do We Say And How Do We Say It?

September 21, 2015
1pm-2:30pm EDT, Online Training

Root Cause Analysis for GCP – A Risk Action Plan Guide

September 22, 2015
1pm-3pm EDT, Online Training
More Upcoming Courses

FEATURED SUPPLIERS

Micro Systems Technologies

Micro Systems Technologies

Starting with the specifications phase, through design, prototypes up to volume production, the MST Group is your reliable partner for turning any of your ideas into a marketable product.