More than five months into a successful recovery from surgery to remove a golfball-sized meningioma, medtech industry veteran Bill Betten reflects on lessons learned. Bill Betten, Betten Systems Solutions A neurosurgeon walks into the room and says, “So you’re the interesting case.” Not exactly words one wants to hear, but the scientist and engineer inside […]
MHRA clarifies U.K. REP role in post-Brexit medical device market
By Ronald Boumans, Emergo Group The Medicines and Healthcare products Regulatory Agency (MHRA), Great Britain’s medical device market regulator, has published new details on the role and responsibilities of the UK Responsible Person if a no-deal Brexit withdrawal from the European Union comes to pass. Get the full story here at the Emergo Group’s blog. […]
Emergo Group launches new RAMS digital medical device RA/QA management system
By Stewart Eisenhart, Emergo Group Emergo by UL has rolled out an enhanced version of its Regulatory Affairs Management Suite (RAMS) platform to provide automated, efficient and cost-effective regulatory affairs and quality management support for medical device companies. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
FDA finalizes guidance on special and abbreviated 510(k) programs
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued final guidance for its Special and Abbreviated 510(k) premarket notification pathways following proposals in 2018 to expand access to these programs, as well as its Refuse to Accept policy for inadequate or incomplete 510(k) submissions. […]
Medical Tubing and Extrusion: Check it out
WTWH Media is pleased to announce the newest media site in its Life Sciences business. Medical Tubing + Extrusion is your go-to source for news about innovations in the medical tubing and extrusion space — and the companies making those advances possible. Part of WTWH Media, the site is a resource of Medical Design & Outsourcing and MassDevice. “In the past […]
Insights Into Drug Delivery Device Manufacturing From Development Through Commercialization
Biologics and other targeted therapies are creating opportunities for innovative device solutions to meet the needs of the formulations as well as specific patient groups. These therapies may require lower annual volumes, and the device manufacturing strategy must fit commercial expectations at those volumes. Optimal manufacturing solutions should mitigate risk while meeting the quality, financial, […]
The Evolving Role of Thermoforming Suppliers in Medical Packaging Design
Today’s medical device OEMs need thermoforming partners to take on expanded roles in packaging design, development and testing. By providing full-service capabilities, thermoformers can enable optimized sterile medical packaging fit for purpose, which may be more sustainable, and can even play a big part in a device’s functionality.
Micro Molding with Bioabsorbables: Not Your Average Thermoplastics
This whitepaper explores Micro Molding with Bioabsorbables. Across the board with plastics, the rules are different when you mold it so small. But when it comes to bioabsorbable resins, they require a much more extensive and specialized approach than thermoplastics. By learning how processing bioabsorbables differs from thermoplastics, medical OEMs can understand the key factors […]
M2M Communication Considerations in Medical Device Development
Machine-to-machine communication (M2M) refers to the sharing of information between two devices. It is a key component in the rapidly growing “Internet of Things” (IoT), the increasing connectivity of devices in the home, workspaces, industry, and beyond. M2M communication can be as simple as the unidirectional transfer of data or as complex as multiplexed signals […]
Teardown: Inside the Neurometrix Quell TENS device
A TENS device for transcutaneous electrical nerve stimulation wraps around the upper calf much like a wristwatch wraps around the wrist. Here are some of its operational secrets. By Lee Teschler A medical device called a Quell performs what’s called transcutaneous electrical nerve stimulation on the lower leg. This technique is said to relieve diabetic pain. None […]
What You Need to Know About the ISO 13485:2016 Update
ISO 13485:2016: An Introduction The international standard ISO 13485 governs the manufacture of medical devices. The first edition was published by the International Organization for Standardization (ISO) in 1996. The ISO currently reviews standards at least every five years to determine whether they need to be updated. The first update to ISO 13485 was released […]
