Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
Get this in your inbox everyday by subscribing to our newsletters.
5. Medical device product development: pitfalls you need to avoid
Managing your medical device product development project can be a daunting task. There are regulations and paperwork to manage, along with expectations such as deadlines or goals for getting the device to market.
I sat down recently to chat with Peter Sebelius about our thoughts on project management best practices for medical device product development. Sebelius is the founder of Gantus.com, where he helps medical device companies with quality assurance, risk management and project management. He is a certified project manager and member of joint working groups on ISO 13485 and ISO 14971. He has vast industry experience and extensive knowledge of medical device standards. Read more
4. Judge: BD owes nothing in Retractable Technologies false advertising case
Retractable Technologies shares are off more than -50% since a federal appeals court last week ruled that nemesis Becton Dickinson & Co. owes nothing for making false advertising claims about its syringes.
The dispute dates back to 2001, when Little Elm, Texas-based RTI sued BD for patent infringement that settled for $100 million in 2004. RTI sued again barely 3 years later, alleging further patent infringement and anti-trust violations. That case was split, with the anti-trust portion stayed while the patent infringement claims were litigated. A federal appeals court decided in July 2011 to reverse an earlier jury finding that both the 1m and 3ml sizes of BD’s Integra retractable syringe infringed the Retractable patent, ruling that only the smaller size trespassed on the intellectual property. Read more
3. Carl Zeiss acquires cataract surgery planning software dev Veracity Innovations
Carl Zeiss Meditec said today it is acquiring cloud-based ophthalmological tech developer Veracity Innovations for an undisclosed amount.
Veracity Innovations developed and produces a cloud-based surgical planning platform for cataract surgeries, covering initial planning, management and analysis of the procedures. Read more
2. Trump signs FDA user fee bill into law
President Donald Trump last week signed a bill to re-up the agreement between the FDA and the medical device and pharmaceutical industries, putting medical device companies in line for a collective $1 billion in user fees.
Companies pay user fees to help cover the cost of the safety watchdog’s reviews of their products. The bill to renew the agreement, the “FDA Reauthorization Act of 2017,” also calls for pharma firms to put up $8 billion for drug reviews. Read more
1. Ex-ArthroCare CEO Baker convicted again in fraud case
A federal jury in Texas last week handed former ArthroCare CEO Michael Baker another loss in his second trial over an alleged $750 million fraud scheme, after a federal appeals court last year overturned his first conviction.
Baker and ex-ArthroCare CFO Michael Gluk were convicted in June 2014 on charges that they ran a scheme to generate false revenue numbers by dumping inventory, first with a distributor called DiscoCare and eventually via free shipments to end-users. ArthroCare was DiscoCare’s only client until it acquired DiscoCare in December 2007. Read more
