Quality Engineering: The Challenges of Digital Transformation in Healthcare

Guest post by Manish Mathuria, CTO and co-founder, Infostretch.

Manish Mathuria
Manish Mathuria

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.

End-to-end test automation is a solution also adopted by a large manufacturer of medical devices and software for treating and managing cancer. The company uses multiple enterprise systems and tools to manage its sales, services and regulatory operations including Salesforce, SAP, and ServiceForce. These systems require timely application updates to ensure staff are up to date on the latest regulatory requirements and equipped with the latest product information all over the world.

This dynamic environment requires the company’s QA team to ensure application quality all around the globe, as new software builds are deployed every two weeks to keep up with the needs of the business.

Working with this client, Infostretch used Tricentis and its TOSCA Continuous Testing Platform because of its risk-based testing, exploratory testing, model-based automation, service virtualization and test data management features. With this structure in place, the medical device manufacturer’s delivery teams were able to automate critical application tests and get immediate and continuous feedback on the potential risks of any new build. They save more than 300 hours of test cycle time per month: 41 staff days.

As cycle times shrink for new digital apps across the industry, and customer expectations rise, testing gets harder and harder, because of the lack of prior art.

Testing innovative products –particularly in a heavily regulated environment like healthcare– is something that every healthcare device or pharmaceuticals developer faces. This wholistic approach is saving timeless hours in the testing cycle and, more importantly, raising the quality of medical devices and software-based products.

Healthcare companies have a significant (albeit necessary) challenge of regulation. But also, they can be inspired by seeing the impact their products have on people’s lives, thanks to the technologies they are developing. By changing the software paradigm from quality assurance to quality engineering, with the continuous testing that that implies, this dynamic industry has a better chance to meet the dual challenges of regulation and market pressures.

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