Is tax reform good or bad for medical device companies?

Medical device companies and others in the healthcare sector stand to benefit from the tax reform Congress passed at the end of 2017, but the picture isn’t entirely rosy, according to a new report from S&P Global Ratings. In many ways, the report offers a corrective to the bullish statements coming from corporate CEOs such

FDA needs to improve medical device regulation, GAO says

FDA is lacking performance metrics when it comes to tracking whether its medical device regulators are following a “least burdensome” approach toward asking applicants for additional information, according to a new report from the U.S. Government Accountability Office. The GAO says in the report highlights: “Until such measures are developed and used, FDA will not

Secant Group officials think they’ve cracked vascular regeneration: Here’s how

Secant Group today announced what it described as game-changing technology to advance vascular regeneration, solving problems that surgeons presently have when it comes to vascular harvesting and the non-resorbable synthetic graft compliance mismatching. The technology, which Secant (Telford, Pa.) developed in partnership with its sister company SanaVita Medical, involves a synthetic, small bore, vessel with a

Light-based medical products: What you need to know

Photonics technologies are everywhere but need a deft touch to integrate into light-based medical products. Scott Wohlstein, The Photonics Group Much like electronics is the study of the electron, photonics is the study of the photon and includes its generation/emission, transmission, detection and analysis. Incandescent/fluorescent light sources, UV lamps, lasers, LEDs, lenses, fiber optics, detectors

How laser marking could solve the medical device industry’s UDI challenges

Here are five ways that laser marking could provide advantages to medical device companies when it comes to meeting permanent marking requirements under FDA’s Unique Device Identification program. Ashir Thakore, SABIC As the U.S. Food and Drug Administration (FDA) implements its phased Unique Device Identification (UDI) program across medical device classes, OEMs are considering methods

3 ways the medical device industry could evolve in 2018

Continued M&A, investment in long-term innovation, transforming business models – those are some of the ways the medical device industry could evolve this year, according to Jeff Greene, EY’s global life sciences transaction advisory services leader. EY today released its 2017 M&A Firepower Report: Life sciences deals and data, which analyzes three life sciences subsectors: biopharma, biotechnology

Medical device companies: These 15 performed the best in 2017

Updated Jan. 5, 2018 Among the most successful medical device companies of 2017, there were two themes: innovation and breadth of services. That was the major takeaway of an MDO analysis of the stock performance of the 100 largest publicly traded medtech companies in the world. What does innovation mean? Think Align Technology (Nasdaq:ALGN) and

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A day in the life of a medical packaging lab technician

Sarah Rosenblum, Packaging Compliance Labs Welcome to the life of a PCL lab technician! Every day is a new exciting challenge with new types of testing, engineering design verification and client interactions. You name it, we can help test it.  All mornings begin with the production meeting: We recap what’s happened the previous day, formulate

Qosina promotes Scott Herskovitz to CEO spot

Qosina (Ronkonkoma, N.Y.) has promoted Scott Herskovitz to president and CEO of the company – a global supplier of single-use components to the medical and pharmaceutical industries. Herskovitz was previously VP of sales and marketing at the company. Scott Herskovitz takes over Qosina from his dad Stuart Herskovitz, who remains board chairman. “I am very excited about

Teknor Apex veteran Robert Brookman dies

Robert Brookman – a vinyl compounding industry expert with 50 years of experience – died last November at the age of 83, according to Teknor Apex Co. (Pawtucket, R.I.), where Brookman was most recently VP of business development. Brookman joined Teknor Apex about 20 years ago after holding executive positions with other compounding companies, with a focus

Keystone Electronics unveils new battery insulating pull tabs

Keystone Electronics (New Hyde Park, N.Y.) recently introduced a new line of battery insulators designed to protect batteries and circuitry from energizing during shipping and storage. Device creators can install the pull tabs in a product along with the batteries so that they can insulate and prevent the batteries from energizing prior to use. Device users simply

How Zeiss microscopes could enable battery innovation

University College London’s Electrochemical Innovation Laboratory is using Zeiss Xradia 810 Ultra X-ray microscopy to study the inner-workings of batteries and fuel cells, Zeiss recently announced. The Xradia 810 Ultra helps researchers to study the evolution of microstructure down to 50 nm resolution. Such resolution offers a 3D picture of the fine details of lithium

Medical device companies need to worry more about liability: Here’s why

Mike Drues has a piece of advice he likes to repeat to clients of his medical device regulatory consulting business: Don’t fear FDA; fear the product liability attorneys. “You should fear the product liability attorneys because they could impose a heck of a lot more damage on a company than the FDA ever could. And by

Medical device startups: Here’s how you successfully plan

The development of the product development plan is an evolutionary effort that continues through the life of the medical device project. Bill Betten, Betten Systems Solutions, and Tom Waddell, Waddell Group This is the second in a series of articles that will discuss the design of innovative products in the highly regulated medical environment.  The

7 top stories that mattered for medtech in 2017

The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are a-changing. Competition is also heating up in areas including diabetes care and robotic surgery. Here are seven stories that mattered for the medical device industry this year. Next>>

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