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.
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.
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.
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.
The medical devices industry has been facing a plethora of regulatory challenges leading to protracted lead times as well as high device development costs for new and enhanced medical devices.
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 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.
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.
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.
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 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.
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.
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, 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.
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.
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 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.