Beyond the Factory Floor: How DHRs Drive Success in Commercialization

Many in the world of product development may be making the assumption that a Device History Record (DHR) is only associated with manufacturing processes. This assumption is so wide-spread, it begs the question—are you leaving value on the table? 

If you take anything away from this blog post, it’s that the power and utility of the DHR goes well beyond manufacturing activities—and could indeed hold tremendous untapped value for commercialization.

Every product company, regardless of industry, benefits from maintaining a DHR. After all, its main function is to record what's produced and ensure alignment with the intended product design. This includes tracking each product unit to its design revision and maintaining an acceptance record detailing every step of its creation. 

Given its utility as a manufacturing record, consider this: the DHR can extend its traceability and value to commercial assets, software, customers, sales, and service.  

These functions of the DHR are important for all products, not just medical devices. Too many people are overlooking the incredible value of the DHR for commercial and sales teams.

Read on to learn more about the DHR and its broader implications.

Understanding the Device History Record (DHR)

At its core, the DHR is an acceptance record that ensures a product is built in line with its intended design. It's tied to a specific revision of the product, ensuring traceability. Some confuse the DHR with the Design History File (DHF). To clarify, the DHF chronicles the design's journey, the DHR narrates the tale of the product itself.

A DHR typically includes but is not limited to

• The date of manufacture.
• The quantity manufactured.
• The quantity released for distribution.
• Acceptance records, which demonstrate the device is manufactured in accordance with the DMR.
• The primary identification label and labeling used for each production unit.
• Any unique device identifier (UDI) or device identifier (DI) associated with the device.

Regulations that impact the DHR, such as ISO 13485 or FDA 21 CFR Part 820.184, have strict acceptance criteria for quality control, such as monitoring processes for sufficient validation, corrective and preventative actions (CAPA), non-conformances, and other activities that affect quality along the production process.

According to the FDA's definition under its Quality System Regulation (21 CFR 820), all manufacturers must maintain DHRs. These records are pivotal in demonstrating that a device aligns with its Device Master Record (DMR) and meets regulatory requirements. 

Why is the DHR Important?

• Traceability: The DHR maintains a record of all device identifications. Know what was built, down to the lot or serial number or control number, and who purchased it.
• Regulatory Compliance: It's not just a best practice; it's the law for medical device companies.
• Accountability: Understand who was involved in the product's creation.
• Safety and Quality: As an acceptance record, the DHR captures every step of the manufacturing process, ensuring that each unit meets the highest standards.

From a business perspective, the DHR encompasses sign-off approvals, ensuring that the right individuals have overseen and validated each stage of production.

In its physical form, the DHR form is often referred to, aptly, as a “Traveler”—a printed template that guides manufacturing teams by being physically passed along as each step is completed. This document is meticulously filled out, scanned, and manually checked. Additional costs accrue for storage, often managed off-site by a third party.  

A “Traveler” DHR form is open to risk given the fact a physical document is vulnerable to manual delays or even loss. Not to mention the increased probability of human error getting overlooked without digital checkpoints or automated parameters. 

Most importantly, traceability—the core benefit of the DHR—is much more inhibited when the record isn’t maintained in a modern cloud-based solution. Not to mention how a modern solution could open up the value of the DHR to other stakeholders in the organization…

Untapped Value: DHR & Commercialization

The Device History Record (DHR) is often seen as a technical document, primarily of interest to product, quality, and manufacturing teams. The truth is its value extends far beyond these activities—especially in the realm of commercialization. 

Traceability, the aforementioned core feature of the DHR, is often seen in the context of product recalls or quality issues. But its value for commercial teams is immense. Knowing the history of a product can inform sales strategies, guide marketing campaigns, and enhance customer service interactions.

The Imperative of Traceability

Imagine a scenario where a product malfunction leads to a harm or a safety issue. Without traceability, your business could face:

• Safety Risks: Risk management is central to traceability. If the worst happens and your product is somehow faulty, you can rapidly trace and correct the specific issue to limit the number of customers or patients affected.
• Operational Delays: Identifying the root cause, isolating the affected customer batches, and implementing closed-loop fixes becomes a prolonged process.
• Financial Implications: The cost of quality (COQ) rises with increased scrap and rework.
• Regulatory Repercussions: Non-compliance can result in hefty fines and product recalls.
• Brand Damage: Customer trust and brand loyalty can be irreparably harmed.

Not to mention, the DHR could have major benefits that have been long overlooked. Here are a few undersung areas where DHR and traceability shine:

• Differentiator: Assets linked to product lots provide insights into customer purchases, enabling service teams to offer tailored assistance.
• Customer Insights: In scenarios like clinical trials, knowing which assets are in use at specific sites offers invaluable data.
• Maintaining Software: Knowing which software version is associated with each released product revision, as well as which software version was installed for each customer. 
• Service Excellence: Field service teams, armed with detailed product histories, can offer efficient and precise maintenance or repair services.

Furthermore, solutions like Propel Software not only seamlessly connect product and commercial teams on one platform, they also integrate all these elements, ensuring effortless traceability from manufacturing to commercialization processes—or, from concept to customer.

The Power of Cloud-Native DHR Solutions

In today's rapidly evolving technological landscape, clinging to traditional methods of maintaining DHRs can be cumbersome and inefficient. The shift towards digital transformation has paved the way for modern, cloud-native solutions that revolutionize how companies manage their Device History Records. Let's explore this digital evolution.

Traditional DHRs, often maintained as physical records or rudimentary digital files, come with a host of challenges such as physical storage issues vulnerable to damage or loss, access difficulties, challenges with version control, and integration hurdles given the rigid silos often found in legacy systems.

Enter cloud-native solutions, which offer a fresh, innovative approach to managing DHRs:

• Real-time Access: Being cloud-based, records can be accessed anytime, anywhere, ensuring that teams, whether they're in the office or on the field, have the information they need.
• Enhanced Security: Cloud platforms offer robust security measures, ensuring that sensitive data is protected against breaches.
• Seamless Integration: Modern solutions can effortlessly integrate with other business systems, from ERP, MES or CRM platforms, ensuring a unified data ecosystem.
• Scalability: As a company grows, cloud-native solutions can scale to meet increasing demands without the need for significant infrastructure changes.

Case in Point: FRACTYL's Digital Transformation

Companies are already harnessing the power of these modern solutions for their DHRs, and even the role they can have in commercialization! Take the innovative startup FRACTYL Health, for instance. They've adopted a Lot History Record (LHR) workflow within Propel. This approach allows them to:

• Integrate cross-functional team approvals: Ensuring that every stakeholder, from design to quality assurance, has a say in the product's journey.
• Tracing commercialization-specific needs: Capturing digital threads like PO numbers, product revisions, sales orders to work orders.
• Connect their platforms: With a shared product lifecycle management (PLM) and quality management system (QMS) platform, FRACTYL has a holistic view of the product lifecycle, from design to distribution.
• Automate workflows: Reducing manual interventions and the potential for errors, ensuring that the DHR is accurate and up-to-date.

Conclusion

The Device History Record, often limited to the manufacturing and quality realm, holds untapped value in the role of commercialization. Its importance transcends industries and departments, making it an indispensable tool for any product company. As we move towards a future where customer service and product experience become increasingly more important—while safety and quality remain paramount—the DHR will undoubtedly play a starring role. 

Explore the Propel platform to see for yourself the revenue-boosting potential of a traceable DHR within a modern solution.