Online version of Handbook: Everything you need to know about medical device creation
What’s keeping you up at night?
Visiting many of the big medical device companies around Minneapolis-St. Paul this year, I frequently asked a question a previous boss liked to use with sources: What’s keeping you up at night?
There were the usual complaints of difficult contract manufacturers or the need to stay on top of potential innovations. But there were two specific items I heard about constantly: worries about the future of ethylene oxide sterilization and the scramble to make the upcoming May 2020 deadline to comply with the European Union’s new Medical Device Regulation (MDR).
Medical Design & Outsourcing has you covered on both of those issues in this year’s Medical Device Handbook.
My colleague Nancy Crotti has been churning out multiple stories a week for MDO about medtech’s EtO crisis. In the Handbook’s sterilization services section, she summarizes where things are currently for medtech’s mostused sterilization method.
“While the FDA has sought input on ethylene oxide alternatives, the EPA holds the power to control its use,” Nancy said.
The Handbook also has a number of articles about the MDR:
- The MDR’s Direct Part Marking (DPM) requirements challenge manufacturers of small-part and orthopedic devices to use the entirety of a part’s complex surface geometry for labeling, according to Dwalin DeBoer at Mack Molding.
- Medical device companies need to strategically shift their business models in order to succeed under the EU regulatory reforms, said David Novotny and Angela Brown at Icon.
- Joseph Tokos at WuXi Medical Device Testing explains how device companies need to make the most of their lab testing partnerships as they prepare for the MDR.
Whether medical device developers are new to, say, catheters, motion control components or tubing, the roughly 50 articles in this issue should help them dip their toes into these areas. Our goal is to provide useful information, versus marketing pitches, from the medical device designers, outsourcers and consultants serving our community.
Wrapping up this issue’s editorial, I’d like to note the end of an era at WTWH Media’s Life Sciences business, as executive editor Brad Perriello moves on to new opportunities.
Brad co-founded MassDevice with Brian Johnson, who is now president of the Massachusetts Medical Device Industry Council (MassMEDIC).
Since 2009, MassDevice has been the online journal of the medical device industry, with hourto- hour coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
Brad and Brian’s recipe for success at MassDevice was simple: Produce solid daily journalism for an industry that needs it. As the new executive editor, I am honored to continue in their footsteps as we produce news and insights that matter in the medical and life science industries.
We are also fortunate to be part of a hardworking and innovative company, Cleveland-based WTWH Media, which over a dozen years has grown into a business with tens of millions of dollars in annual revenue.
Additionally, we have promoted veteran business journalist Nancy Crotti to managing editor of Medical Design & Outsourcing and Danielle Kirsh to senior editor. And we welcome Sean Whooley to our team as assistant editor. Tom Salemi, previously content director for The MedTech Conference, joins us as editorial director for DeviceTalks.
Expect even more great coverage from our medical device team in the future.
Medical Design & Outsourcing