In a constantly evolving regulatory landscape, life sciences manufacturers are being pushed to implement systems that connect the enterprise, the value chain, and the product at every stage of its lifecycle, while verifying the risk/benefit ratio in a closed-loop fashion.
Along with EU MDR/IVDR compliance, we’ve seen an increase in FDA warning letters for statistical analysis deficiencies, a stronger emphasis on risk management for medical devices with ISO 14971, and the FDA moving away from the Quality System Regulation to ISO 13485. It’s also now mandatory to incorporate cybersecurity into the risk files and account for unintended device use.
The digital thread has great potential in life sciences because it enables a seamless flow of data across the value chain, connecting clinical, product development, manufacturing, and post-market surveillance data.
Implementing the digital thread can help, but it won’t happen overnight.
Digital thread maturity is sporadic, and most companies are generally immature. Many still use paper-based or point systems. Most companies have no overarching enterprise architecture or digital thread roadmap to guide them based on strategic imperatives, compliance mandates and market demands. Others lack governance and are faced with rampant acquisitions and divestitures, which further exacerbate these challenges.
Unanticipated disruptions like COVID-19 have made the digital thread more important than ever. The challenges today serve as a call to action for the life sciences industry to invest in its future, but the path forward is still not clear.
Value Based Healthcare and the Digital Thread
As the industry continues to shift toward value-based healthcare with a focus on product quality and safety, digital transformation and incorporation of closed loop connected data are paramount. Companies that continue to focus only on pure compliance and siloed business processes will struggle to deliver on product quality and patient safety.
To change the mindset of the industry, the 2011 Case for Quality (CfQ) initiative recommends manufacturers focus more time up-front on product quality versus pure compliance. This strategy relies on digital transformation and harmonization of cross-functional activities that contribute to the safety and efficacy of each device.
Key Elements of the Digital Thread in Medical Device
Product Development
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Foundational Product Lifecycle Management (PLM) Systems – PLM can enable a product concept to move into production through an efficient engineering change management process, designed to provide the right information to the right people at the right time. As the product moves to production, sourcing managers can access the BOM to communicate effectively with suppliers.
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Extended Reality – Sales professionals can provide a virtual demonstration of the product leveraging the digital twin and augmented reality, so customers can assess the product’s real-world capabilities. These models are also used to train healthcare workers in the field without requiring in-person training.
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Servicing Excellence – When a device is not working properly, it disrupts patient care and must be fixed ASAP. With a digital thread in place, a nurse simply scans a code to a virtual technician, who diagnoses the problem based on feedback from IoT sensors and resolves the problem with an augmented reality app.
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Smart Connected Products – With connected products, companies can run predictive analytics on data and alert technicians of devices that are at risk of malfunction before they occur. This allows technicians to proactively service the product and reduce downtime.
Manufacturing
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Manufacturing Execution System (MES) – With MES, companies can digitally connect, monitor, and control all their manufacturing processes. An important output of this system is the Device History Record that proves the company correctly manufactured the device to specification.
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Industrial Internet of Things (IIoT) – Sensors allow companies to monitor production equipment and find ideal operating conditions to increase production yield, optimize energy consumption and decrease the cost of poor quality.
The Prescription for Digital Thread Success
How can organizations move from their deeply entrenched legacy systems to a state-of-the-art digital ecosystem? More importantly, how can they train their people to embrace and make use of these tools?
Here are some basic tips for implementing the digital thread and digital twin successfully.
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Don’t worry about perfecting the digital transformation roadmap. Instead, we recommend a simultaneous, dual-pathway approach. The first path should focus on digital transformation, smart connected factories, and smart connected products. The second path should focus on tackling business problems leveraging new and emerging technology.
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Don’t just focus on technology. Consider creating short term digital proof points with measurable business value.
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Define the capabilities the organization needs to have the greatest business impact. This is a combination of people, process and technology that will support an actual digital transformation that is sustainable and scalable, no matter what the future brings.
The Bottom Line: Now is the Time
World class companies are already enabling the digital thread by leveraging the power of Internet of Medical Things (IoMT) and a consolidated digital quality management system (QMS) that connect the buyer, provider, patient and manufacturer.
IoMT is estimated to save the healthcare industry $300 billion annually1. Digital QMS can reduce the cost of poor quality by up to 40%2. Instead of using multiple point systems to achieve EU MDR/IVDR compliance, consider the implementation of a digital QMS for a consolidated source of truth. Advanced analytics and connected data can also improve products, speed development times, increase production yield and revolutionize field service.
Now is the time.
Companies that want to remain competitive must move forward on their digital thread initiatives.
