Christine BlindellChristine Blindell of UDI Compliance Solutions discusses the emerging market in medical device labeling that is being fostered by a massive change in the mandate issued by the Food and Drug Administration governing the way all medical devices will soon be cataloged and registered with the federal agency. Understanding the reach and impact of the new Unique Device Identification (UDI) system and the way that the Global Unique Device Identification Database (GUDID) will work is crucial to anyone working within the medical sector and also supplies plenty of useful lessons for start-ups in other seemingly unrelated verticals as well.

 

For anyone unfamiliar with UDI, can you explain the basics of what it is intended to accomplish?

The Unique Device Identification (UDI) mandate issued by the Food and Drug Administration is the kind of thing that in hindsight feels like it should always have been in place. However, until recently, the ability to automate some of the data input and to make use of such a massive amount of big data would not have been practical. The longstanding problem was that medical devices in the past had very little information required from a labeling point of view. There really wasn’t any sort of universal system or centralized registry in place to unify all of the companies manufacturing, designing, distribution and utilizing the vast number of devices that are brought to market or resold each year.

As you might imagine that creates some serious flaws in the old system, where product recalls or counterfeit devices can cause major problems or even be a matter of life and death. The FDA has now taken the initiative and created the new Global Unique Device Identification Database (GUDID) as a primary repository of all of the information that will be collected about each device bought or transferred in the United States. This also has huge implications for companies outside the USA because selling their devices into this country will still require them to be fully UDI compliant. Each UDI registration includes as many as eighty different data points and that number is likely to expand as new item parameters are added. For consumers the benefits are very obvious, but it also presents a challenge for companies that now must comply with these new regulations or potentially face significant legal responsibilities and penalties for any failure to act properly or omission of the required information.

My company, www.UDIComplianceSolutions.com bridges the data gap for many clients who are seeking to become fully compliant without having to hire entire departments full of new personnel to handle their UDI filings in house. We can provide a revolutionary software solution that is cloud based and capable of processing their device filings or we can provide the expert staff to handle all aspects of their UDI compliance in a turn-key manner from data entry to confirmed GUDID inclusion.

How did you become the first UDI solution to reach the market in the United States?

As any entrepreneur will tell you, that was partly a matter of hard work but we also benefited a great deal from timing and good fortune. My team and I have decades of experience in the medical labeling vertical and strategic partnerships already in place with leading companies like Zebra, Fujitsu, VantageID and others in the space. That gave us the earliest opportunity to act, so I wouldn’t take credit for that, but one of the main things I would say we did right is that we did jump on that opportunity with vigor and we have pushed forward really well as a team from the first moment of inspiration through each milestone we set for ourselves along the way. Having a terrific team is crucial, because even in an area of commerce that is likely to be dominated by computer software and algorithms, it will also be the human resources that dictate the success of the venture, and UDI Compliance Solutions has a professional team that is unsurpassed by any I’ve ever managed.

Where did you see medical labeling and healthcare going next organizationally?

I view UDI Compliance as the first inkling of what is coming and I believe it will soon become a significant change in the way many other sectors handle their data eventually. The ability of companies to create data and for government agencies or others with jurisdiction to parse that data at a granular level will give way to levels of efficiency that are an order of magnitude beyond what most people now believe to be possible. We are headed for a world where buying a car based on a VIN number really is no longer sufficient. In the future you may be able to determine just about every service stop, repair, add on or other relevant change that has been made to that vehicle from the day it rolled off the assembly line to the day it rolled into your driveway – regardless of how many owners it had in the interim or how many years it has already been on the road.

Big data isn’t coming anymore… it’s already here and the medical / healthcare sector is first to act mostly because of the profound importance it has on the lives and well-being of the people these devices serve. However, once those systems are properly implemented, as we have seen time and time again, other sectors will adopt similar systems for tracking items and building a living history of the mechanical devices we all rely on.

What lessons can you share from what you have learned while bringing UDI Compliance Solutions forward?

Build the best team. Everything else really matters more with a great team or less with a weak team around you. Too often I find that entrepreneurs think of themselves in solitary terms as if their team is somehow interchangeable parts when nothing could be further from the truth. The better your team is the more time you can allocate to doing things and the less time you need to waste facilitating things that should be getting done on their own by a competent crew of highly qualified team members.

If you aren’t sure if you have the right team or not… you have the wrong team. The right mix of personalities, skills and traits is something you can sense right away in any start-up group. It’s not about whether you occasionally bicker, anyone in a high stress fast paced environment is destined to disagree from time to time. What matters are the results. Are you getting more done than you expected? Is the work something you can be truly proud of and present to others with complete confidence? Is the work something you can spread evenly across the entire team or is it getting lumpy with a few key contributors handling the real chunks that matter while others leave the heavy lifting for someone else? Getting these initial decisions right and putting the right people in positions where they can succeed is the single most important thing any CEO can do for the long term growth and potential of any business worth developing.

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Christine Blindell is the CEO of UDI Compliance Solutions, a company that is presently working with many leading medical manufacturers, wholesalers, distributors and designers to bring them into full compliance with newly established FDA regulations designed to protect the health and security of medical patients in the United States.