3 keys to a higher value launch for IVD

Amanda Brantner, Ximedica Launching a new IVD technology can involve many hurdles and risks, but investment dollars abound for technologies that can demonstrate significant value in the healthcare market. “Investment and fundraising in the healthcare ecosystem saw a banner first half of 2017, driven in part by advancements in artificial intelligence and machine learning for

Spectrum Plastics announced fundamental business platforms

Spectrum Plastics Group today announced three fundamental medical business platforms as it seeks to better explain the breadth of services the new company can provide the medical device industry. Spectrum (Alpharetta, Ga.) is just six months old – formed from the merger of Pexco and PPC Industries. “From component manufacturing to packaging and finished device assembly,

Comparing EO and VPA sterilization

As medtech advances, device makers need to consider sterilization methods that won’t compromise electronics, drugs or biologics. Matt Conlon, Revox Sterilization Solutions The medical device industry has undergone an impressive transformation over the last several years, resulting in new and innovative devices and solutions. As companies continue to innovate, they are finding that commonly used sterilization

How to work with a preclinical contract research organization

When outsourcing medical device laboratory testing, knowing what the regulatory and business requirements are up front is critical to the success of your testing program. Amy A. Schade, Felice Randi LaMadeleine and J. Heléne Andersson, Toxikon Requests such as unusual application of technical or regulatory guidelines, shortened timelines, nonstandard study designs and custom reports are

Simplifying product testing and validation with fastener torque auditing

Capturing data during a product’s manufacturing process can help ensure the quality and consistency of that product. Here’s how that process plays out with fastener torque. Thomas Moore, Futek One of the scariest phases of product design is testing & validation. That’s when any unknown flaws or manufacturing defects will see the light of day.

How to select sterile barrier systems for reusable medical devices

Sterile barrier systems are key components in medical device sterilization, so selecting the right barrier is essential. Jason Pope, Nelson Labs Reusable medical devices, prior to use in healthcare facilities, must undergo validation testing to demonstrate the effectiveness of the cleaning instructions and the microbiocidal instructions that will be provided to the healthcare facility. Often, the

Avinger slashes jobs, Q3 sales down 61%

Avinger (Nasdaq:AVGR) – maker of the Lumivascular image-guided, catheter-based system to treat peripheral artery disease (PAD) – continued to experience declining sales as it retrenched during the third quarter, according to its newest earnings report. The Redwood, Calif.–based company has been cutting jobs and other costs – and focusing on existing accounts and winning FDA clearance

Medtronic is closer to VenaSeal coverage: Here’s how

Medtronic is touting its new CPT codes for the VenaSeal varicose vein closure device – codes that company officials think bring the device closer to positive coverage from public and private insurers in the U.S. CMS announced the new codes on Nov. 1 as part of final rules for the 2018 Medicare Physician Fee Schedule (CMS-1676-F)

How have medtech launches and prototyping evolved with 3D printing?

Here are three basic ways that 3D printing can help you get your medical device project off the ground. Jim Medsker, Keystone Solutions Group Additive manufacturing, commonly referred to as 3D printing, began to surface in the 1980s. Since then, the technology has quickly become a valuable tool for creating plastic prototype parts in a rapid

Sterigenics parent company is now Sotera Health

Sterigenics International said today that it has changed the name of its parent company to Sotera Health, with Nelson Labs, Nordion and Sterigenics as Sotera’s three operating companies. The new name drew its inspiration from the name of the Greek goddess of safety, Soteria, and is meant to reflect the company’s commitment to global health.

Greenlight Guru adds Grow to quality management software platform

Greenlight Guru recently announced the introduction of its Grow software product to assist medical device companies with quality management after product launch. The Indianapolis-based company’s first product, Go, focused on helping medtech companies utilize design control, risk management and document management software to bring FDA and ISO-compliant medical devices to market in less time. Many

Nelson Labs parent Sterigenics buys Toxikon’s European lab business

Sterigentics International is seeking to turn its Nelson Labs business into a global extractables and leachables lab testing platform through its acquisition of Toxikon’s European division. The purchase of Toxikon Europe, announced yesterday, represents a capabilities expansion when it comes to serving the pharmaceutical and medical device industries. Sterigenics’s Nelson Labs business will now offer Toxikon

High-volume manufacturing: 4 points to consider before you scale up

Scaling to high-volume manufacturing requires companies to think ahead and prepare for the future early in the product lifecycle. Here are four points to reflect upon before your company scales up. Gavin Wadas, B. Braun Medical, OEM Division High-volume manufacturing typically involves the introduction of automation into the medical device fabrication and assembly process. A

How Igus moving plastic components are enabling medtech innovation

Advanced plastic components maker Igus sees more medical sector opportunities. Here’s how its e-chains, bearings and linear systems are enabling innovation.  Igus – maker of advanced plastic components including e-chain cable carriers, bearings and linear systems – has its main medical customers in Europe. But that could soon change. The company plans to sell to

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DeviceTalks West: Expertise you need to know

Medical device suppliers are light years away from the days when they merely filled orders to spec for medtech OEMs – as a visit to the upcoming DeviceTalks West will quickly confirm. From incorporating steerability into catheters to getting validation and testing done right, the companies serving the medical device industry have become specialized experts in

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