Third-party providers currently service almost one-third of all endoscopes and generate about 20 percent of the revenues in this space, exerting tremendous competitive pressure on OEMs. Here's a look at how third-party providers are getting a leg up, as well as steps OEMs can take to retain - and even grow - their market share.
When designing a medical device, material selection can be difficult, especially with thousands of plastic material options available. While material properties, environmental effects, regulatory requirements, and cost almost always are considered, "feel" is often overlooked – despite its importance to user and patient satisfaction, as well as market success.
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.
In a clinical trial considering different phases, there is a need for subjects to be enrolled as per the eligibility criteria defined in the study protocol.
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.
Emerging competitors are gearing up to challenge the dominance of Intuitive Surgical's Da Vinci Surgical System and other established players in the field of robotic-assisted surgery by offering mobility, affordability, and technological advantages.
The U.S. Food and Drug Administration (FDA) has announced that it will host a public workshop where experts in traumatic brain injury (TBI) research — including industry names GE Healthcare and Banyan Laboratories — will present the latest advances in TBI biomarker research and advise FDA on the technology’s specific regulatory challenges.
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.
Wenzel Spine, Inc., a pioneer medical device company focused on providing minimally invasive, stand-alone alternatives to traditional spinal fusion, announced today that it received clearance from the U.S. Food and Drug Administration (FDA) to market VariLift-LX as an interbody fusion device for stand-alone use in the lumbar spine.
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.