Category Archives: Risk

Risk Assessment
Risk Management

UDIs and Patient Safety

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.

Counterfeit Medical Device Parts

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.

Patent Protection: Interview with Kirk Teska

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,

http://urbusinessnetwork.com/intellectual-property-patent-law/

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.

Air France Flight 447: Mystery Solved

The mystery of Air France Flight 447 – which disappeared, crashing into the Atlantic Ocean in good weather off the coast of Brazil in May 2009 – is no longer a mystery.imgres-1

The causes: a breakdown in communication; unclarified assumptions about team roles; deskilling of the workforce; and arrogance about previous success.

images
Sound familiar? Whether it is a highly complex, state of the art airplane or a medical technology designed, honed and manufactured under highly regulated conditions: we can become our own worst enemies.

William Langewiesche analyzed the tragedy of Flight 447.* Early in his article, he states his thesis clearly:

Over the years, “automation has made it more and more unlikely that ordinary airplane pilots will ever have to face a raw crisis in flight – but also more and more unlikely that they will be able to cope with such a crisis if one arises.”

Today “the very design of the . . . cockpit is based upon the expectation of clear communicationimages-5 and good teamwork.”

3 hours and 41 minutes into the flight from Rio to Paris, ice crystals clogged 3 air-pressure tubes. That knocked out the cockpit’s 3 airspeed indicators. This did not materially affect the performance of the aircraft. But it startled the pilots. “The episode should have been a non-event, and one that would not last long.” But it set off a chain of reactions by the pilots in the cockpit. It became unclear who was in charge. Assigned roles were ignored. There was confusion about who had done what and why. As a result, the plane went into a stall – clearly announced by the computer, but virtually ignored at first in the actions they took. In less than 5 minutes, the plane hit the surface of the ocean at a descent rate of 11,000 feet per minute.

images-2

As in the case of the West Africa Ebola epidemic, we see catastrophic consequences of admirable and generally successful efforts. Langewiesche is clear about this in the article: “the new airplanes deliver smoother, more accurate, and more efficient rides – and safer ones, too. . . . Since the 1980s . . . the safety record has improved fivefold.”

But the resultant “deskilling” of airplane pilots means that for today’s pilots “most of their experience had consisted of sitting in a cockpit seat and watching the machine work.”

The hard-won wisdom of project management can help us better use – and protect ourselves from – advanced technologies.

  • Risk assessment: “What can go wrong?”

  • Think about the big picture. “How will this piece of technology fit into the human experience of x?”

  • Surface the assumptions that underlie this project – and proceed to “perfect” the technology cautiously.

  • View people – veteran, resistant pilots; newer, less experienced pilots; regulators; clients; naysayers – as allies to learn from, not as adversaries to beat down.

*Vanity Fair, October 2014, “The Human Factor: Anatomy Of an Airliner Crash