Under FDA regulations, most medical devices will now include a Unique Device Identifier (UDI) in human- and machine-readable form, creating a system to track and monitor the quality, safety and durability of every medical device. The public will be able to search and download information on specific medical devices.
In this Medical Development Insights interview, I discuss with Jonathan Bretz and Dick O’Brien some of the critical issues that companies now face in coming into legal compliance and the importance of “safety surveillance” through UDIs. Without reliable and consistent identification of medical devices, it is extremely difficult to identify counterfeit products and to help staff distinguish between devices that are similar in appearance but serve different functions.
These issues have recently taken on greater importance as it has been revealed that the federal Centers for Medicare & Medicaid Services has pushed back against plans to include UDIs on Medicare and Medicaid claim forms.
Trademarks are business assets. Safeguarding their value in medical device and life sciences product and service businesses and product lines is too often not considered until late in the development and marketing process. But as assets, trademarks are best protected if established as early in the process as possible.
Robert Adelson, a corporate and tax attorney for over 30 years, discusses key aspects of trademark protection:
- Value of choosing “suggestive” brand names for businesses, products and services, and value of trademarks as a commercial asset
- Registration process to protecting of brand names in Use, and those desired on an ITU – Intent To Use basis
- Pitfalls to registration, and how to avoid loss of trademark protectio
Click here to listen to this Medical Development Insights interview on the UR Business Network.
In another “Medical Development Insights” interview, I spoke with Rich Nadeau and Al Cruz about counterfeit medical device parts. They had prepared some interesting thoughts for the FDA-MDG conference on October 30, 2014. Rich is the Founder and president of eComp-Electronic Components Inc, a 14 year old company focused on specialty distribution and counterfeit product detection. Al is a Senior Product Quality Engineer III, at Hologic, where he develops, modifies, applies and maintains quality plans and protocols for processing materials and products. They met when Al went to Rich with a concern about failure rates in one of the products he was testing.
Counterfeit medical products cause risks to consumers’ health and well-being, adversely affecting companies by loss of sale and loss of reputation when counterfeit parts fail. With the ease of access that the Internet provides to procurement offices, the medical dangers of counterfeit parts have grown.
I have recently begun an Internet radio interview show, titled “Medical Development Insights,” on the UR BusinessNetwork: http://urbusinessnetwork.com/medical-development-insights/
In this conversation,
along with Jeff Karg, I interviewed Kirk Teska, an attorney with over 20 years of intellectual property law experience, managing partner of the intellectual property law firm Iandiorio & Teska based in Waltham, MA, and professor at Suffolk University Law School in Boston. Jeff is Director, Program Development, for TechEn, where he oversees project engagements by aligning client needs with TechEn’s suite of services and capabilities. He is the primary inventor on 22 patents in areas ranging from inhalers and drug delivery devices to water filtering faucets and blood collection disposables.
In the interview, Kirk examines intellectual property patent protection for medical devices, something he presented at the October 1, 2014 MDG monthly forum on “Intellectual Property Approaches To Safeguard Value.” He covered several key points:
- Myths the general public – and many entrepreneurs – have about patents
- What the potential inventor needs to know
- How to work with patent attorneys
Kirk Teska’s book, “Patent Savvy,” was published in the fall of 2007 by Nolo Press. His second book, “Patent Management,” was published by ASME in 2010.