Category Archives: Change

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.

Ingenuity of the Bionic Ear : Cochlear Implants

Sam Silberman has had a hearing problem since he was a young child. His parents got him a hearing aid early on, and as he grew he replaced his hearing aids with ever newer hearing aids. But in 1999 he did something transformational for himself: he had a cochlear implant. From somewhat indistinct sound and speech, he immediately leapt to clear sound and increasingly clear speech. Today you wouldn’t know he has a hearing problem unless he told you.

With my co-host, Kevin Franck, I interviewed Sam and we explored his journey from deaf child to Senior Area Manager for Cochlear Americas, the global leader in bionic hearing devices.

Click hear to listen to the interview.

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

Medical Device Leadership In an Uncertain Time: A Manifesto

Payments / reimbursement under the Affordable Care Act . . .

Purchasing consortia for hospitals and other health care providers . . .

Lower profit margins than in the previous decade . . .

An uncertain future in both FDA and foreign regulations . . .

Minimal venture capital interest in this industry . . .

How will medical device leaders choose which research directions to follow,

which product lines to invest in?

 

images-1

The 1990s and 2000s are rather widely acknowledged to have been the heyday of finance.

Milton Friedman’s philosophy that increasing the financial wealth of shareholders was the sole justifiable principle for a corporation now governed all economic policy, seeped even into U.S. Supreme Court decisions.

The compensation of investment bankers was (and remains) the envy of all. The free-wheeling lifestyle, “masters of the universe” power, invulnerable occupational security and exciting posture on the forefront of cutting edge economic growth left many in awe and envy. Finance came to dominate all discussions of industrial and economic policy. There was practically no sector untouched by the growth of the financial industry – none that exceeded its enormous growth.

Then came the crash(es) of the last 15 years, and the vulnerability of our bets on the financial industry as the leader of growth was exposed. Losses were great – and left bare how much of the “growth” had been paper growth, not raw development.

This may be the time to capitalize on products and service as our key economic benchmark. This may be an opportunity to seize an advantage in the effectiveness, the documented outcomes of fewer, but better, products and services.

images-3

Yes, it is difficult, risky and expensive to demonstrate effectiveness of medical devices, biologics and drugs. There are likely to be fewer (financial) winners, and the rewards may be smaller (on paper; quarterly) than in the previous decade; so, indeed, there may be fewer entrants into the race.

On the other hand, might we recapture an earlier (really, not that long ago) criterion of success: building a firm with lasting power, grounded in the security of demonstrated effectiveness, successful outcomes that could be counted on by health care providers for years to come? They are often the ones who persevere. They are the heroes, not only of the industry, but of the economy.

images-2

Let’s think of “economic” over “finance.” Etymologically, “economy” means management of the household. “Finance” comes from a French origin meaning “payment/ending of a debt.” Economic policy – managing the good of our national well-being – should be the overriding category and priority, with financial success a subset – not the other way around. In that world medical devices companies can flourish. That is the opportunity we now have.