By Manish Mathuria, chief technology officer and co-founder, Infostretch.
The truism that “prevention is better than cure” is especially true in software, where a defect can have serious, sometimes life-threatening, consequences. Digital health presents a unique set of challenges and opportunities for those operating in this competitive and demanding market. The pressure to innovate and advance is immense, but so are concerns about safety, functionality, cost and privacy, to name a few.
When clinical insights combine with IT brilliance, the results can lead to fascinating health innovations. Radical new approaches, such as wearables and mobile devices which monitor, analyze and diagnose conditions, bring special meaning to the importance of error prevention versus recovery.
Lightning-fast technological innovation, fierce competition and stringent regulation combine to bring special challenges to a tester. The implications of software failure are severe. Another adage, “evolve or die,” springs to mind. The traditional testing function is what needs to evolve in this sector perhaps more than any other.
The quality assurance approach to testing must now make way for quality engineering, a new way of tackling quality control which focuses on improving the inherent design of the product throughout the software development life cycle. Why? Because traditional testing, performed at the end of the SDLC is out of its depth in the new era of digital transformation.
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.