Medical device companies are beginning to see the value of digital transformation. Although digital transformation has affected nearly every function within an organization—or will at some point—I believe quality management teams will be among the most affected.
 
Of course, I am biased. I spent most of my career in medical device manufacturing companies and was a VP of Quality Management Systems before moving to Sparta Systems. I believe business transformation is achievable through the power of quality systems, and quality teams are in a unique position because they touch virtually every point in the value chain. More importantly, however, the role of quality teams is changing.
 
Digital transformation’s underlying technologies—cloud computing, machine learning, smart sensors, and more—will help quality to adapt to those changes, and help their companies change the way they deliver products and services.
 
But even with all the benefits there for the taking, successfully executing a digital strategy has its hurdles. Quality teams at medical device companies must weigh the benefits against risks and create their strategy accordingly.
 
Are Medical Device Quality Teams Embracing Digital Transformation and Its Benefits?
While many medical device quality teams have been quick to adopt a “digital-first” mindset, others have been slow to accept change. Moreover, a 2017 McKinsey report noted how medical device companies are slow to adopt new technologies compared to other industries. 
 
But ignoring digital transformation will place companies at a competitive disadvantage. Every day there are vast quantities of data produced from the billions of devices that touch nearly every aspect of our personal and professional lives—data that can provide unprecedented customer insights and streamline processes.  
 
Some of the chief benefits for medical device companies as it relates to digital transformation include:

• Speed: As the preferred pace of the digital-first world increases, the same expectation is had regarding the speed of going to market and/or resolving potential quality or manufacturing issues.
• Innovation: As Industry 4.0 evolves from buzzword to reality, the need and demand for a patient-centric approach continues to be one of the key drivers for innovation. Leveraging technologies like 3D printing, IoT, and cloud computing help ensure customers are at the center of the value chain. 
• Collaboration: Mergers and acquisitions, along with increasingly complex multinational supply chains, make coloration a challenge. But with the help of digital transformation platforms, companies can turn those challenges into competitive advantages by using shared or intimately connected platforms across businesses and geographies.

Why Now Is the Time to Embark on Digital Quality Management
Historically, quality leaders at medical device companies have cared about five key imperatives: quality, efficacy, safety, continuity of supply, and compliance. But that approach has evolved. We’re now shifting as an industry from compliance being the reason for a quality system to more focus on innovation and cutting-edge technology. Keeping in mind the five key imperatives along with enabling innovation, a bi-modular approach comes into play and the challenge to balance both modes becomes stronger each day. The bi-module breaks down as follows:

• Mode One: Traditional and Proven—Focused on driving down cost and taking a more traditional, predictive approach.
• Mode Two: Exploratory—All about innovation, major disruptions, and fast-paced changes. 

As the tension between modes one and two becomes tighter, companies must find a balance to be successful and provide better patient care because the customer also drives digital transformation. Today, customers shape products and services, along with the supply chains of said products and services. Across the industry, product access is going digital. People are searching, discovering, and buying digitally, and the customer has different expectations on how a system or product works for them. With the customer experience in mind, medical device companies seek to integrate the latest technologies into existing business models and IT architectures to improve services—and at the same time, complying with ever-present regulatory and risk-related concerns.
 
The potential benefits from digitalization extend beyond increased productivity for medical device manufacturing. Digital transformation allows valuable insight into the production process, helps identify errors in the process, and improves efficiency. These benefits could combine to allow manufacturers to make smarter choices for their business.
 
It’s no secret that there are many components and complexities that go into launching a digital transformation strategy, but it shouldn’t deter the life sciences industry from adopting new and innovative digital processes. Instead, companies must embrace today’s digital-first world to better serve patients.