Guest post by Manish Mathuria, CTO and co-founder, Infostretch.
Digital transformation means different things to different industries. On the consumer front, Amazon didn’t even have to transform itself, because it was born in the digital age. On the other hand, for pharmaceutical and medical device manufacturers, much of their innovation is heavily dependent on the move from a physical, analog world to a digital world.
This brave new digital world is fraught with perils, partly because of the necessary regulation, and partly because many digital advances represent new ground, so there may be no precedent for assuring product quality (which in this example translates to patient safety). Indeed, topping the complexities facing many healthcare companies is the fact that they are operating in a regulated environment, both in the U.S. and globally. The U.S. FDA and other regulatory agencies worldwide require them to maintain strict vigilance on the testing of products, while at the same time they want to be doing rapid development.
Take LifeScan, for example, an operation of Johnson and Johnson. With a long history in the medical devices field, its blood glucose monitoring (BGM) line is one of the most-prescribed brands in the industry. LifeScan is taking the conventional BGM device full-bore into the digital era, with a concentration on mobile. As you might expect. their market is growing at a healthy rate (much as diabetes is growing at an “unhealthy rate”), and they face competition both from established companies and innovative newcomers, notes Ed Hein, Manager – Digital Verification and Validation at LifeScan.
LifeScan is enabling patients to track their blood glucose readings on their mobile devices and online; their healthcare providers and health management companies can access their data via API interfaces. This provides faster access to the data and more accurate tracking and trending. Being able to present that data to the patients, their providers and loved ones more accurately lets them live a normal life.
Like other companies in the healthcare field, LifeScan’s competitive advantage and market position was strengthened by its ability to accelerate cycle time to get new software-based capabilities to market faster and more efficiently. This meant changing its software testing approach from traditional –often manual– Quality Assurance (QA) to a more proactive Quality Engineering (QE) process that integrates software testing and development and leverages automation.
This transition has been common in some industries but is rather new in healthcare. The good news is that it is driving innovation and, because of more efficient and effective testing processes, accelerating product approvals (READ: time to market).
By integrating QA more tightly with the development process, LifeScan has also been able to integrate its organizational structure as well. This has provided additional visibility to additional opportunities to accelerate the development lifecycle.
Guest post by Ken Perez, vice president of healthcare policy, Omnicell.
Tracy Morgan, the “30 Rock” and “Saturday Night Live” star, once said, “Bad news travels at the speed of light; good news travels like molasses.” Such is the case with respect to the cost and clinical performance of the U.S. healthcare system.
Steven Brill, founder of Court TV and the American Lawyer, famously pilloried America’s healthcare system in “Bitter Pill: How outrageous pricing and egregious profits are destroying our healthcare,” the cover article in the March 4, 2013 issue of Time and the longest in the history of the magazine. Brill wrote, “In the U.S. people spend almost 20 percent of the gross domestic product on health care, compared with about half that in most developed countries. Yet in every measurable way, the results our health care system produces are no better and often worse than the outcomes in those countries.” In a subsequent article in the Jan. 19, 2015 issue of Time, Brill went on to describe the U.S. as having “a broken-down jalopy of a health care system.”
Brill’s “Bitter Pill” article received generous coverage by CBS, the Commonwealth Club, the Huffington Post, the Los Angeles Times, National Public Radio, the New Yorker, the New York Times, and even Jon Stewart’s “The Daily Show.”
The July 28, 2015 issue of the Journal of the American Medical Association (JAMA) included an article, “Mortality, Hospitalizations, and Expenditures for the Medicare Population Aged 65 Years or Older, 1999-2013,” that shared the findings of a study of over 68 million Medicare fee-for-service and Medicare Advantage beneficiaries by H.M. Krumholz, et al.
This lengthy, detailed, heavily footnoted, and carefully written study reported the following encouraging findings:
From her hospital bed, the little old woman gathered herself beneath her tissue-paper thick blankets and wondered about many of the things she’d face in her future. Though the room wasn’t cold, wringing her hands through the folds of the cheap cloth were all she could do to keep herself calm.
The television blared above her prone body; it made the only noise except for the rasp of her short breath. Occasionally, an orderly passed by but made no effort to breach the curtain door, and made her way down the hall.
A newspaper lay unopened at her side, not a word of it read, mostly because of the glaucoma in her right eye. Thus, the television called out, it being the only thing to steer her thoughts back from the darkness and confusion that seemed to take hold.
A relatively healthy 95-year-old women prior to the automobile accident (that consequently was not her fault), she seemed to suffer the unimaginable at her age and come out alive. Though doctors wouldn’t guarantee her recovery during the first few days, they were more optimistic now that her broken leg, broken arm, fractured wrist, broken shoulder and cracked ribs had not killed her.
She’d made it this far, they reasoned; and if the whole experience didn’t kill her then certainly it would make her stronger.
So alone she sat, except for when the occasional visitor stopped by, much of the time scared and most of it confused.
In came the food, out went the plates. In came a doctor, what was left were his orders. The occasional nurse checked her machines and gave her a pill; conversation was limited to, “How are you feeling today?” or “Are you in pain?”
There’s no surprise she feels out of place. Clearly, thoughts of giving up come to mind and she wonders if she’ll be able to survive the three or four months of required physical therapy for her to recover.
Even worse off, without any real family to guide her through, she sat quietly trapped in her own thoughts.
Finally, at one point, randomly looking at the computers in the room, she said softly, “Everything is mechanical now.” It was a statement, like something said in fear and loathing. She wrung her hands some more and closed here eyes.
When the nurse came in, the old lady requested a pain pill and the nurse left to retrieve it. Upon her return, the nurse handed over the small white pill and a shot of water and said she’d stay until she was sure it had been swallowed.
Thirty seconds later she was gone, again. Alone, the old woman tried to remember her home and its warmth and did her best to recall a lifetime – nearly a full century – in which she’d been engaged lovingly by family and friend.
It’s all mechanical, now, she said again, wondering in silence as her companion, the television, blared on.