INDUSTRY PERSPECTIVES

Insiders’ Guide To Winning In the Drug Delivery Device Market — Part 3: Quality Systems
Insiders’ Guide To Winning In the Drug Delivery Device Market — Part 3: Quality Systems

I recently sat down with Christopher Eustace of Hospira, who has over 27 years of quality experience in both the pharmaceutical and medical device industries, to discuss how a combined QS program is necessary for life science companies striving to capture their piece of the delivery device market.

  • Buy, Or Bye-Bye? How To Vet Novel Medical Device Technologies
    Buy, Or Bye-Bye? How To Vet Novel Medical Device Technologies

    While there are numerous influencers, but it is clear that technology acquisition and development is the engine now driving medical device innovation. This guide describes how to evaluate new technology appropriately by looking at two key components: The technology’s core performance characteristics, and its appropriateness to users and their expectations. 

  • An Introduction To Global Business Services (GBS) For Medical Device Manufacturers
    An Introduction To Global Business Services (GBS) For Medical Device Manufacturers

    Global business services (GBS) is a service delivery framework that requires executives to think differently about their businesses, operating more effectively through a combination of outsourcing and automation to enhance customer and stakeholder satisfaction. Each organization’s approach must be customized to match the capabilities and service needs of that organization.

  • Applying Evolutionary Thinking To Point-Of-Care Diagnostic Design
    Applying Evolutionary Thinking To Point-Of-Care Diagnostic Design

    When it comes to designing a point-of-care device, revolutionary thinking is not as useful as evolutionary design. Incremental changes, and not paradigm shifts, are the norm.

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WHITE PAPERS & CASE STUDIES

How To Choose Injection Molding Partners, Part 1

Selecting the right injection molding partner is crucial for a successful project. The costs and timescales can be a significant part of a project budget. 

Metallographic Examination Of Medical Implants

Metallographic examination has become an indispensable tool in the testing, quality control, failure studies, and post-mortem analyses of implantable devices. This paper presents techniques and results for examination of titanium-based acetabular cups and Co-Cr-Mo femoral hip stems and knees.

4 Avenues To Leveraging A Smartphone In Your Connected Health Product

Connectivity has evolved alongside the proliferation of the smartphone and the two are coming together to redefine how we manage our health. Considerations such as durability, battery life, security, user experience, and much more must be considered as you develop a connected medical solution, but the principal consideration for any smartphone is its principal purpose: Connectivity and communication.

Laser Marking Metal For Medical Applications

Medical product marking and decoration is used for inventory control, process management and internal tracking, branding, and functionality. In many cases, lasers provide the preferred means of marking and identifying those products.

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PRODUCT & SERVICE SHOWCASE

Custom Prisms Custom Prisms

Precision Optics Corporation can custom manufacture prisms with tolerances to .01mm, <10/5 scratch/dig, λ/20 flatness, <5 arc second parallelism, +/- 0.1mm; 0.2mm to 150 mm diameter, and +/- 0.02mm (and as thin as 0.2mm) thickness.

Lead Frame / Insert Micromolding Lead Frame / Insert Micromolding

Accumold's tooling and automation systems for lead frame molded parts and insert applications are second to none. Components can be singulated and shipped bulk, or tape-and-reel to our customers.

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.  

Medical Device Engineering Services Medical Device Engineering Services

Phase 2 Medical employs an engineering team with vast experience in the complexities of assembling, testing, and packaging single-use, disposable medical devices. Their engineers specialize in the LEAN manufacturing of medical devices.

Avalanche Photodiodes (APDs) Avalanche Photodiodes (APDs)

First Sensor has a large selection of high sensitivity, high speed and low dark current photodetectors optimized for ultraviolet, visible and infrared light as well as ionizing radiation. Package solutions include surface mount (SMD), through hole (THD) devices

Contract Manufacturing for Single Use Finished Medical Devices Contract Manufacturing for Single Use Finished Medical Devices

Passion for technology has driven SMC Ltd. to be a leading manufacturing partner to the top medical device OEMs. With operations spanning the United States, Costa Rica, and India, SMC is positioned to assist you on your next finished medical device.

 

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FEATURED SUPPLIERS

STERIS Isomedix Services STERIS Isomedix Services

STERIS Isomedix Services has been committed to providing contract sterilization services to the medical device, pharmaceutical, consumer, and industrial communities for over 40 years. Blending industry-advanced technology with a team approach to Customer service, STERIS Isomedix Services offers the industry’s most comprehensive advantage, encompassing radiation and ethylene oxide sterilization.

REVOX Sterilization Solutions REVOX Sterilization Solutions

REVOX Sterilization Solutions is part of the Cantel Medical Corp.; a company dedicated to infection prevention and control.  Our in house experts include mechanical engineers, chemists, microbiologists, quality assurance and regulatory affairs professionals. The REVOX team will work to understand your challenges, concerns, and opportunities and provide expert insight to help you decide if REVOX Sterilization is the right sterilization solution for your product or product concept, and/or operational efficiency improvement goals.

LATEST HEADLINES

  • Imec Presents Compact Lens-Free Digital Microscope At Photonics West

    At SPIE Photonics West 2016, imec will demonstrate a lens-free microscope for large field-of-view live imaging at micrometer resolution. Imec’s on-chip lens-free microscope can be integrated into life sciences and biotech tools, targeting multiple applications such as label-free cell monitoring, automated cell culturing, or automated high-throughput microscopy.

  • Stryker Acquires Synergetics’ Neurosurgical Portfolio
    Stryker Acquires Synergetics’ Neurosurgical Portfolio

    Stryker has snapped up Synergetics’ neurology portfolio in an all-cash transaction.  Synergetics specializes in microsurgical instruments for ophthalmic and neurological applications, and currently manufactures electrosurgical generators and disposable neurosurgical tools as part of its OEM relationships with both Stryker and Johnson & Johnson (J&J). Pending approval of the deal, these assets will transfer to Stryker.

  • Senate Committee Advances Bills To Facilitate Device Trials, Improve Safety Of Reusable Devices
    Senate Committee Advances Bills To Facilitate Device Trials, Improve Safety Of Reusable Devices

    The U.S. Senate Health, Education, Labor & Pensions (HELP) Committee in a preliminary meeting advanced two key bills affecting the medical device industry, part of a larger raft of counterpart legislation for the House of Representatives' 21st Century Cures Act that attempts to overhaul the U.S. Food and Drug Administration’s (FDA) regulatory framework.

  • UPMC Partners With Lantern, Leads $17M Investment Toward Online Mental Health Wellness Services

    Lantern has announced the close of a $17 million investment led by Pittsburgh-based healthcare giant UPMC. The investment reflects a commitment from Lantern and UPMC to transform the way emotional wellbeing services are delivered and accessed in the U.S. UPMC was joined by all previous Lantern investors, including Mayfield Fund, SoftTech Venture Capital and Stanford University.

  • GRAIL Taps Google Exec Huber As CEO To Lead Early Cancer Detection Development
    GRAIL Taps Google Exec Huber As CEO To Lead Early Cancer Detection Development

    GRAIL, a cancer diagnostic company focused on developing a blood test for early-stage cancer detection, has appointed Jeff Huber, a former Google executive, as CEO. GRAIL is building on “ultra-deep sequencing” science and technology developed at Illumina, Inc. 

  • Medtronic, St. Jude To Advise FDA On Leadless Pacemakers
    Medtronic, St. Jude To Advise FDA On Leadless Pacemakers

    The U.S. Food and Drug Administration (FDA) is set to meet representatives from Medtronic and St. Jude Medical to gather information and recommendations on leadless cardiac pacemakers. The hearing, scheduled Feb. 18, 2016, will provide the agency a basis for regulatory decision-making and future guidelines covering said devices.

  • NHS Invests $6B To Digitize U.K. Health System
    NHS Invests $6B To Digitize U.K. Health System

    The U.K.’s Department of Health has pledged over $6 billion toward its latest efforts to digitize the National Health Service (NHS). New initiatives will seek to overhaul existing digital systems, pushing toward a paperless health system and greater integration of remote patient monitoring. The U.K. Health Secretary’s announcement of a renewed effort comes amidst mounting pressure for the NHS to cut costs and address the security issues that have flawed previous digital roll-outs.

  • Solvay’s New PESU Material Offers ISO 10993 Biocompatibility For Demanding Healthcare Applications

    Solvay Specialty Polymers, a leading global supplier of high-performance materials, introduced Veradel HC A-301 polyethersulfone (PESU) recently. The medical-grade polymer retains transparency and stiffness at high temperatures and offers processing advantages over other commercial high-heat, transparent polymers.

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UPCOMING TRAINING COURSES

Medical Devices - Effective Complaint Handling and Management February 16, 2016
1pm-2:30pm EST, Online Training
Answering Your Top 5 GCP Questions From 2015! February 17, 2016
1pm-2:30pm EST, Online Training
How to Write SOPs That are GCP Compliant and Implementable February 24, 2016
1pm-2:30pm EST, Online Training
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