Closing the Loop to Overcome a Disrupted Life Sciences Reality

Introduction

The demand for organizational visibility, control, and collaboration to achieve resilience is a catalyst to modernization and digital transformation in the Life-Science industry.

Successful medical device manufacturers are increasingly using a closed loop cloud- native platforms to quickly respond to unforeseen events. This approach allows manufacturers to accelerate new product introduction, improve customer satisfaction, and lower costs while remaining compliant.

During this webinar, we discussed opportunities to leverage technology to:

• Using Cloud solutions to enable Positive Disruption
• Driving Collaboration and Visibility Across the Product Lifecycle
• Closing the Loop to Improve Visibility Across the Value Chain
• Deploying a Digital Strategy to Provide Resilience

Using Cloud Platforms to Support Digital transformation

Axendia’s research shows that Life-Science industry executives have become “Cloud Comfortable.” (Read:  Where Does Your Organization Fall on the Cloud Comfortable Scale?)

“Life-Science organizations are embracing a cloud-first approach and digital transformation.  This migration is accelerated by the current environment,” said Kevin Chien. “The digital imperative of moving to the cloud is happening faster than ever before in Life-Sciences,” he added.

Organizations are moving from a transactional approach to a connected patient-centric and outcomes-based model and from managing individual projects to nurturing collaborative solutions to stay engaged with customers.

Cloud-based platforms drive efficiency and effectiveness in today’s global, mobile, and remote work reality.  In addition, a consolidated cloud platform provides benefits including flexibility, standards-based integration frameworks, fast deployment, and a modern user experience.

Customer-centric business operation platforms enable teams to align across functional areas, sharing success metrics throughout the product lifecycle and the value network that support closed loop visibility, control, and collaboration.

Driving Collaboration Across the Product Lifecycle

The deployment of systems and technologies that support improved visibility, control, and collaboration to drive resilience have put forward-thinking organizations in a good position to deal with disruption. Unfortunately, many organizations are facing challenges managing their business in this new virtual and remote reality.

Those companies that did not have technology in place are trying to figure it out under pressure and even those organizations who “thought” they were prepared have been caught flatfooted with legacy applications unable to cope with the load of remote work.

Current approaches are ineffective!  63% of survey respondents said their processes are less than effective (Read: The Future of Change and Configuration Management in the Med-Tech Industry).  However, this is not due to a lack of technology, but instead, due to the implementation of too many systems. For decades, Life-Science organizations have implemented point solutions in an effort to meet regulatory requirements and an attempt to eliminate paper. 

Unfortunately, this has led to the proliferation of disconnected point solutions that often focus on managing “static documents” that make collaboration and visibility across the product lifecycle difficult. 

This has resulted in ‘swivel chair’ integration, where data from a report in one system is manually entered into another system in an attempt to gain visibility.  This approach is not effective.

For decades, the exchange of paper based documented evidence had been the mandatory method for interactions between industry and regulators.  However, now regulators are driving industry to shift from documented evidence to digital evidence and quality metrics to support a new regulatory framework.  (Read:  Is Your Quality Unit Ready to Submit Quality Metrics Data Across Your Supply Chain? )

To address this issue, innovative companies have adopted a cloud culture and are able to support streamlined business processes, while taking advantage of the availability and security associated with cloud platforms.  In addition, companies who have proactively implemented cloud solutions are able to manage the current disruption more effectively.

Chuck Serrin pointed out that there are many benefits to using a single platform, including closing the loop across QMS, PLM, CRM and Field Service management.  Putting PLM at the core enables companies to fulfill the promise of the technology: managing products across the complete lifecycle from design to patient.

“In an effort to create better products, prevent problems early and improve patient outcomes, Imperative Care realized that it needed to be able to track product and component quality issues many levels deep into the PLM BOM structure,” shared Chuck Serrin.  “Leveraging the platform, they were able to assess the complete history of the product and it’s components past quality issues, before they made their way into the new next-generation product,” he added.

Closing the Loop Improves Visibility Across the Value Chain

Disruption is not a new phenomenon. Hurricanes Sandy and Maria, the tsunami and earthquake impacting Fukushima, Japan, and the ash cloud from the volcano in Iceland disrupted supply chains around the world.  However, most companies were able to continue operations by shifting production capacity to unaffected areas. Unlike those earlier disruptions, the COVID-19 pandemic is affecting the entire world simultaneously, sparking a desperate competition for limited resources and supplies.

While we never anticipated a disruption of this magnitude, our research shows that the Life-Science industry acknowledged the need to address the lack of resilience due to limitations in visibility, control and collaboration for over a decade. (Read: COVID-19 Black Swan Colliding with Your Supply Chain? ). 

Industry executives have been concerned about the lack of visibility across their supply chains even before the current pandemic.  70% of industry executives responding to our research reported having key suppliers abroad.  43% indicated having significant concerns due to single sourcing stemming from risks associated with Black Swan events.

As a result, many organizations are transitioning from single source supply chains to resilient value networks.  This requires technology that enables improved visibility and control across the value chain to close the loop and prevent disruptions early in the process. Capturing Voice-of-the-Customer from CRM, previous quality events from QMS, past service records from Field Service management as well as regulatory and marketing requirements to identify intended use data, an integrated solution supports closed loop visibility across the product lifecycle.  

“Having tightly integrated processes provides business value from the early R&D stages to be connected into clinical evidence needs and regulatory for submission globally, as well as reimbursement and market adoption, through the commercialization as well as post complaint management and post market surveillance process. One platform provides a complete view of the information and data across the product lifecycle” commented Kevin Chien.

In Brief

The demand for organizational visibility, control and collaboration across the product lifecycle and the value chain to achieve resilience is a catalyst to modernization and digital transformation in Life-Sciences.

The ability to integrate QMS, PLM, CRM and Field Service management on a single platform creates a closed loop approach that improves product design for quality while managing worldwide compliance and providing a competitive advantage.

Companies that adopt a cloud culture, are able to close the loop and overcome a disrupted Life-Sciences reality.  Leveraging an integrated platform allows them to support streamlined business processes, while taking advantage of the availability and security associated with cloud platforms.

View the complete Axendia “Straight from the Source” webinar On-Demand

Stay tuned for the next webinar in this series as we discuss additional insights on technology’s role overcoming a disrupted Life-Sciences reality with industry thought leaders.

 This brief was written by Axendia, Inc. and presented by Propel PLM. The opinions and analysis expressed in this brief reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date.  Information cited is not warranted by Axendia but has been obtained through a valid research methodology.  This document is not intended to endorse any company or product and should not be attributed as such.