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

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

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.  

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.

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.

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

  • 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.

  • Smith & Nephew To Distribute OrthAlign's Total Knee Arthroplasty Tech

    OrthAlign, Inc., a privately held U.S.-based medical device company developing precision technologies, has entered into a multi-country distribution agreement with Smith & Nephew for its award-winning Total Knee Arthroplasty (TKA) technology, KneeAlign.

  • FDA Clears LifeWatch's Continuous Vital Signs Monitoring Service

    LifeWatch AG, a leading developer and provider of medical solutions and remote diagnostic monitoring services in the digital health market, is pleased to announce that it has received FDA clearance for its continuous Vital Signs Monitoring Service.

  • Medtronic Gets FDA Clearance For First MRI-Safe CRT-D Devices
    Medtronic Gets FDA Clearance For First MRI-Safe CRT-D Devices

    Continuing its track record of introducing the first magnetic resonance imaging (MRI)-safe cardiac devices to the market, Medtronic recently gained approval from the U.S. Food and Drug Administration (FDA) for cardiac resynchronization therapy defibrillators (CRT-Ds) for heart failure patients undergoing MRI scans.

  • World’s First 3D-Printed Titanium Cranial Implant Cleared By FDA
    World’s First 3D-Printed Titanium Cranial Implant Cleared By FDA

    The U.S. Food and Drug Administration (FDA) has cleared the first 3D-printed cranial/craniofacial plate implant to be made from titanium. Brazil-based BioArchitects’ implant uses Arcam AB’s electron beam melting (EBM) technology to combine the precision and customization of 3D printing with the light weight and high tensile strength of titanium alloys.

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UPCOMING TRAINING COURSES

Analyzing and Understanding ISO 13485 Proposed Changes February 10, 2016
1pm-2:30pm EST, Online Training
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
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