"Thriving in a Digital Era, Part 1"

In a medical examination room, a patient with a mass of electrodes attached to his chest and arms stepped onto a treadmill in preparation for a cardiac stress test. After about 12 minutes of intense physical movement, the medical staff proceeded to gather data about his heart rhythms and electrical activity. That experience compelled the patient to question why biometric data couldn’t be monitored remotely without all the wires and electrodes.

That patient is Steve McCalmont, founder and CEO of BraveHeart Wireless Inc., a developer of a wearable body health and biometric sensor, called the Life Sensor. The device’s functionality allows health care providers to monitor a patient’s heart rate, pulse, blood oxygen, skin temperature and more from anywhere in real time. The technology behind the Life Sensor is designed to provide a less disruptive health monitoring process for patients and enable medical professionals to offer more comprehensive, up-to-the-minute patient care.

Architecting for the Future

To develop the Life Sensor, BraveHeart implemented digital technology solutions out of the gate. The device also functions as a platform for other health monitoring products so it needs to be compatible with a variety of technologies. Being motivated to get the device on the market, BraveHeart’s executive leadership mapped out an aggressive product launch schedule. Setting up a modernized IT infrastructure and incorporating an automated quality management solution ensured that quality paralleled every phase of development. As a result, they have been able to stay on track with development milestones and regulatory compliance audits.

“We’re on an enormously aggressive schedule. You have to get things right, quickly,” said McCalmont. “We needed to make sure we had the right tools in place so that when our partners and OEMs come in to audit us, information is available quickly and efficiently, and we’re compliant with all their standards.”

BraveHeart is one example of life sciences organizations looking to leverage the connective benefits of the fourth phase of the industrial revolution — Industry 4.0. From steam-powered machinery to electricity to computerization, the evolution of product design, manufacturing and labor has always been driven by advancing technology.

Over the years, society and workforces have adapted to progress by weaving new technologies into their existing processes. Industry 4.0 is not just about assimilating new technologies, it’s also about redefining the organizational culture. In order to remain competitive in your industry, as well as keep up with evolving global regulations, you need the interconnectivity and flexibility that Industry 4.0 delivers.

In our latest executive brief,“Architecting for Change: Embracing a Platform Approach,” you will discover valuable insight on how utilizing technologies such as predictive analytics, cloud computing, configurable software applications and risk-based validation is key for quality professionals to thrive in a digital era. Instead of reacting to issues, digital technology makes you more agile and predictive in flagging problems ahead of time, which is the best approach to sustain continuous improvement. Overall, your IT infrastructure will be more stable and secure, and your business will be better organized and more productive.

Reactive to Proactive: Creating an Integrated Ecosystem

All of the concepts under the Industry 4.0 canopy can be summed up as a digital transformation. Digital technology not only elevates our capacity for new discoveries and innovations, it raises our expectations for what is and what should be possible. A modernized technology foundation involves digitizing all your systems across the board — eliminating the need for paper. This creates an agile ecosystem that lets you rapidly adapt your business as needed and get products approved and on the market faster.

Digital transformation is also encouraging existing life sciences organizations to re-examine their legacy operations and even restructure their business models based on a fresher perspective of their industries and consumers. Instead of reactively addressing current challenges and needs, companies are able to use digital technology to be more innovative. All the data that is now available needs be compiled, organized and analyzed in order for it to be useful. Automated data collection, real-time data access and predictive analytics enables companies to more accurately identify trends and design products that will have relevance far into the future.

Scaling for 2022 and Beyond

Growth, market expansion and remaining competitive are high priorities for most businesses. Achieving these objectives is becoming more complicated and challenging for various reasons, most of which involve advancing technology:

• More diverse, technology-savvy startups are entering the life sciences playing field. Venture capitalists are shelling out unprecedented sums to progressive startups and small businesses that are able to quickly move products to market.
• Disruptive innovators are converging with niche life sciences companies to open new markets for each organization.
• More health care-related products are becoming technology-based, which means companies need to invest in staffing a software development team or acquiring an existing technology company.

These concepts are transforming the market dynamics across the life sciences sector on a global scale. This will fundamentally change the business strategies of incumbent companies striving to maintain a strong position in their markets. Success in this endeavor hinges on an organization’s willingness to modernize its operations and IT infrastructure and establish a culture of adaptability.

Read the entire executive brief: “Architecting for Change: Embracing a Platform Approach.”

And don't miss the second of this two-part blog series, which provides an in-depth look at operating in a cloud environment.