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Design Transfer: Best Practices for Translating Your Device Design into Manufacturing Specifications

Manufacturing specifications are successful when they result in your medical device being produced consistently, over and over, and meet requirements and expectations, including those of design intent and quality specifications. In this blog post, I’ll share the best practices I follow when translating a medical device design into manufacturing specifications, specifically the drawings and specifications of parts and assemblies.

1: Start early

When thinking about the typical medical device product development paradigm, design transfer is usually depicted as one of the steps right before commercial production. Sometimes it is shown in parallel to design validation, and always after detailed design and engineering and design verification.

However, in reality, design transfer, especially the translation of your device design into manufacturing specifications, should start earlier.

Creating the right manufacturing specifications starts in the detailed design and engineering phase of product development. Manufacturing specifications are the drawings, part specifications, work instructions for assembly, testing requirements, and other elements of the Device Master Record (DMR), or the ‘recipe’ as I like to call it, to be able to produce your product. Thus, it’s key to be already deciding which technologies will be used to produce your parts and using a Design for Manufacturability (DFM) process to make assembly easier and more efficient and reflect those decisions in your drawings and specifications. And like the product development process itself, translating your device design is iterative in nature. Starting in the detailed design and engineering phase allows you to follow the steps further defined below.

2: Involve your manufacturing partners

This is the time to involve your manufacturing vendors for their input as to how to specify the custom parts and assemblies they will be supplying. They are the most knowledgeable regarding the tolerances and limitations their processes can generally provide while you, as the final device manufacturer, are the expert on the final design intent and criticality of the parts or assemblies they are providing. Working together will result in drawings and specifications that can be manufacturable and meet design intent. This is also another good time to incorporate other Design for Manufacturability (DFM) aspects for the largest positive impact to the design.

RELATED: Five Key Design Control Practices that Improve Compliance and Help Develop Better Products

3: Incorporate risk

Translating your design specifications into manufacturing specifications is not a time to omit incorporating risk. Reference your risk analysis to determine which parts have functional and safety implications and tailor the specifications, including the quality specifications accordingly.

4: Remember the quality specifications

Speaking of quality specifications, having a strong quality control plan, based on risk, is also part of a successful translation of design specifications into manufacturing specifications.

Elements of a quality control plan include quality agreements with vendors; part validation expectations; various inspection requirements, including during receipt of first articles, incoming, in-process, and final acceptance testing; and ongoing process monitoring. Aligning expectations with suppliers of critical components is key. I see these quality specifications as partners to the part and assembly drawings and specifications.

Inspection testing is a good example to see the relationship from a design input specification to a manufacturing specification, specifically in this case, to an in-process testing specification. Say your device has a design input specification for a minimum flow efficiency of 80%. The 80% is based on the clinical need of the device. During design verification, the design is tested with a statistically relevant sample size to have an efficiency of 95% ± 2%. This range is also measured during process validation. Thus, in-process testing can be set at an 89% minimum. Note, this is intentionally tighter than the original design input, so that process issues and drift can be detected earlier.

Another example is related to sterilization. Say the design input is for a sterile product to have a one-year shelf life, i.e., the sterile barrier must maintain its integrity for one year. In this case, a Tyvek heat-sealed pouch is selected as the sterile barrier. During detailed design and development, the specific pouch is selected, the parameters for sealing are determined, and the corresponding peel strength of the seal is measured. Then design verification testing verifies that the pouch, when sealed under the selected parameters, does indeed maintain its sterile barrier after one year (accelerated aging). At this point, the corresponding peel strength of the seal can be used as an in-process specification to monitor the sealing performance. This minimum force specification is based on the performance data measured to date (typically from process validation), with adjustments to accommodate the observed manufacturing variability. Thus, the design input to have a one-year shelf life of the sterile product is translated into a manufacturing, in-process testing specification of a minimum peel test force of the seal.

RELATED: Complying with FDA Design Control Requirements Using Requirements Management Principles

5: Create your traceability matrix

The FDA and other regulatory agencies expect a trace matrix associated with your medical device to show linkages from User Needs through Design Validation.

In the trace matrix, it’s where you can see the direct linkages between part and assembly (design outputs) specifications to corresponding design input specifications. Note that it need not be a 1:1 relationship. Multiple part/assembly specifications can be linked to a design input, and one part/assembly specification could fulfill multiple design inputs.

Here’s a snippet of a trace matrix for a fictional home-use thermometer. Especially for more complex medical technologies, a requirements tool such as Jama Connect® makes it more efficient to create and manage a product’s traceability matrix and ensure there are no gaps. As the Design Output column are manufacturing specifications, this is where you can see the traceability between the design input specifications to manufacturing specifications. It’s in this column where the manufacturing testing requirements in the examples above would be listed.

And a well-specified trace matrix is a good tool to use to understand the impact of future design changes, both for changes that occur after the design has transferred to manufacturing, as well as for any changes that may result from design verification and design validation. At times, if the risk is appropriate, you can choose to perform some design verification activities and design validation activities in parallel. Test units for design validation must be production equivalent, thus being able to trace which revisions of the design and resulting manufacturing specifications used units for design verification activities and design validation activities is important and to be able to justify the impact of any differences.

There are many activities to consider as part of manufacturing transfer. These best practices focus on translating the device design into part and assembly drawings and specifications, including the quality specifications, that are a part of ensuring your device is made the right way every time.

In this post, we’ll explore how Jama Connect for Medical Device Development is designed to help you get ramped up quickly with a platform, training, and documentation aligned to industry regulations ISO 13485:2016, 21 CFR 820.30, and ISO 14971:2019, while applying a proven systems engineering approach to product development.

With this solution, medical device teams can manage design controls for device requirements and related risks, simplifying regulatory submissions and audit preparations while accelerating time to market.

Manage Design Controls for Device Requirements and Related Risks in a Single Platform

Easily Demonstrate Traceability

Traceability ensures that design inputs have been met and verified, providing necessary evidence from the design control process. Jama Connect allows you to easily produce traceability documentation required by regulators.

Manage Risk Analysis

Manage risk analysis, aligned with ISO 14971:2019. Jama Connect helps teams identify and mitigate risks earlier in medical device development, saving teams from frustrating late-stage design changes and supporting the path to regulatory compliance.

Maintain Audit Trails and Export Data

Real-time reporting and baselining allows you to track all changes to information within the system, including timestamps and associated users. Data is easily exported from Jama Connect if your current process dictates storage of documentation in a quality management system (QMS).

Reuse and Baseline Management

Compare versions of a requirement, generate branches to develop a variant, and create catalogs of reusable requirements to improve medical device development.

Compliant Reviews and Approvals

Increase early stakeholder visibility and participation in the review process with electronic signatures that are compliant with FDA 21 CFR Part 11.

Design Verification and Validation

Seamlessly manage traceability to verifications and validations, providing evidence to comply with government regulations and standards, like 21 CFR Part 820.30.

Flexible, Scalable Options with Jama Connect for Medical Device Development

Jama Connect for Medical Device Development Solution’s license model is fully scalable, ensuring rapid deployment and easy adoption of the solution across your product development team. It also allows flexibility and can be customized to your team’s unique needs. Download this datasheet to learn more about key product benefits and features, unique licensing types, and templates templates provided as part of the solution.

To see more information specific to the medical device development industry, we’ve compiled a handy list of valuable resources for you!

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As medical device manufacturers develop complex products, they require a product development approach capable of managing that complexity.  

At the same time, manufacturers must continue to ensure compliance and alignment with regulations and standards. These define requirements that ensure safety and quality and reduce risk—but ultimately do not prescribe specific tools or techniques. 

This is especially apparent in design control activities. Regulatory requirements define the “what” for compliance but leave the “how” to the manufacturer, as long the procedures describing that “how” remain documented and prove sufficient as part of the quality system. 

This lack of a prescribed approach to managing design controls can lead to uncertainty, but Jama Connect for Medical Device Development envisions that gap as an opportunity. Here, manufacturers have the space to deploy systems engineering techniques within design control activities, supported with a robust requirements, risk, and test solution. 

Note: Now that our medical device blog series is concluded, you can go back and read the series intro, Part I, and Part II.

Bring systems engineering into the design control process to manage medical device complexity. 

Systems Engineering solves the problem medical device manufacturers face. It takes a complex problem and divides it into manageable units so developers can see the solution both holistically and in its interrelated parts.  

Aligning to 21 CFR 820.30 and ISO 13485:2016 can naturally guide manufacturers towards this approach, requiring trace across user needs, design inputs, design outputs and verifications. The guidance does not account for the abstraction required within these areas, especially design inputs, allowing the manufacturer to determine and implement appropriate techniques and tools.  

The Jama Connect for Medical Device Development solution includes: 

A Procedure and Configuration Guide   
An out-of-the box configuration of Jama Connect

Together, these components bring Systems Engineering principles and design control requirements into a single recommended approach. 

Here’s how.

1. Apply systems thinking.

The FDA guidance (FDA, 1997) indicates that product concepts are to be “elaborated, expanded, and transformed into a complete set of design input requirements.” Jama for Medical Device Development’s procedure guide applies systems engineering principles during this design input process. 

User needs are fulfilled by functions of the system.
The system allocates them to specific engineering teams or product components for further, discipline-specific definition.

In some instances, like where software is the system, abstraction of design inputs from system-level to subsystems may not cross disciplines. However, the need for hierarchical product definition remains and is reinforced by software specific standards such as IEC 62304 and IEC 82304.

2. Capture and organize design inputs.

In Jama Connect, these levels of abstractions are managed as Item Types, discrete objects within Jama Connect that allow the solution to enforce rules for how information should trace to one another.  

Concept-level information is captured as Intended Use and User Needs, engineering design responses as System and Subsystem Requirements. The total resulting set of requirements are referred to as the Design Inputs.

3. Establish the trace.

Below is a Relationship Rule provided as part of the out-of-the-box configuration of Jama Connect for Medical Device Development. In blue are the concept-level and design inputs: 

These Item Types are unique data elements within Jama Connect. They allow us to create logical groupings we can use to manage the hierarchical levels of abstraction and to further organize across disciplines.  

 Standardizing engineering principles for requirements management using discrete Item Types is a valuable shift. It shows customers shifting focus from pure document generation to support for how they actually work, which can range from top-down, to middle-out, to bottom-up product definition.

The end result: Actionable information and accepted design inputs.

This shift to a focus on discrete items instead of whole documents encourages teams to act on information as it becomes ready. By capturing status within each individual item (e.g., a specific system requirement), items are independently driven from “Draft “to “Accepted.” 
 
“Accepted” indicates a requirement is ready for: 

Documentation in the Quality Management System (QMS). 
Further decomposition or development. 
Defining Verification.

This single state can initiate several activities for other teams and does not require full document completion, which tends to restrict visibility and reduce momentum. 

Although this approach encourages a shift from a document-focused product definition, in reality a document needs to be generated for the Design History File (DHF). To support these potentially conflicting needs, the out-of-the-box configuration: 

Drives organization of information based on a systems engineering approach.  
Uses Jama Connect’s filtering capabilities to pull together information across the project for document generation.

Using filters for document generation allows you to do more than collect different types of requirements for a single document. You can use data within the items, specifically in the Status of the items, to generate a document of only accepted design inputs. You can also take a baseline as part of the document generation process. The result is a snapshot of accepted design inputs that you can use for comparison reporting to show how design inputs may have changed over time. You can also indicate in each item’s version history which version of a requirement was included in the generated documents. 

 Use this Design Inputs approach with the Jama Connect for Medical Device solution to make it easier to generate documentation you need while supporting how you work with systems engineering approaches. 

  In the next post in this series, I’ll show you how to connect design inputs with design outputs and verifications.   

Watch a demo to see key Jama Connect Medical Device Development Solution features in action and understand how teams use it to support their development process.

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Editor’s Note: In a time where remote collaboration and distributed teams are quickly becoming the norm rather than the exception, we’re proud to share this post on the value of effective collaboration around medical device design and product development. This article was originally published here on May 5th, 2020 by MedTech Intelligence and written by Jama‘s VP of Customer Success, Clay Moore.

How Effective Collaboration Can Expedite Medical Device Design

Medical device companies are committing significant resources to the fight against Covid-19. Collaboration tools can help expedite product design while supporting evolving compliance standards.

Weeks after the COVID-19 lockdown, medical device companies continue to face challenges as they manage remote engineering teams working rapidly to keep up with a changing environment. Now that the initial shock has passed, companies are becoming more well-versed in their new workplaces and identifying how to keep remote engineering teams working successfully.

Teams are under pressure to meet quality and compliance standards while staying on pace to hit delivery dates, and optimizing the efficiency of remote engineering teams as they develop complex devices can be difficult. Normally, products can undergo multi-month-long review cycles, which tie up valuable resources. Technology, when properly leveraged, can reduce that review cycle by as much as 75%—a vast improvement.¹

Effectively streamlining collaboration is key to expedite design reviews and medical device product launches. The following is how companies can use collaborative technology to maximize output while meeting critical health standards.

Reduce Dependency on Documents

Medical device companies have been forced to come to terms with their current processes to see if they work for remote engineers. Most know that helpful technology exists, but platforms that promise to streamline lengthy processes can be intimidating. Companies that delayed digital adoption are especially disadvantaged.

The document-based requirements management approach often used by medical device companies limits visibility into the design process across teams. This makes it difficult to scale across multiple product lines and versions, especially with teams working remotely, and it increases expenses.

Collaborative requirements management software can help engineers easily communicate and smoothly define, review and validate information digitally to ensure projects are tracking and a clear path to compliance and launch is visible. Effective software reduces manual processes that limit innovation and add time to development.

Medical device companies should seek collaboration tools that help their engineers clearly communicate the path to launch, tasks and ownership, and current status and action items needed. Remote work on complex processes requires seamless communication and understanding where work is being bottlenecked so teams know how to direct their attention.

Stay On Top of Compliance

In the medical device industry, understanding current product regulations is key to shape the product development process. In recent weeks, the FDA has issued changes to its 510(k) program, and the European Parliament voted to delay the EU Medical Device Regulation.^2,3 Companies who have a centralized approach and real-time access to requirements and design can minimize the added overhead of regulatory requirements, streamline development, and minimize risk.

When companies lack resources to efficiently locate regulatory standards and swiftly communicate them to engineers, they’re wasting time and limiting the ability to mitigate risk. Using traditional collaboration tools or Word documents to manage the product development process isn’t effective, leading to teams spending days or weeks to pull together documentation in preparation for an audit. Ensuring compliance requires context and visibility throughout the design process, and innovative tools that structure collaboration and put compliance and regulation at the forefront can provide both.

Good requirements management software uses a lifecycle approach to make sure compliance is integrated into the design process. Team members are held accountable, and workstreams keep track of when signoffs occurred.

Getting compliance right can be a challenge with engineers working remotely—but it is too important and too costly to get wrong. It can cost $600 million to recall a product.⁴

Remote Collaboration Sets Medical Device Companies Up for Success

Companies forced to embark on their digital transformation journey during this pandemic can save valuable time and money on product launches by embracing requirements management software to help streamline communication, structure collaboration, and ensure compliance.

This level of collaboration is more prevalent than ever, especially considering the state of work may change as we know it. In fact, a Gartner, Inc. survey revealed that 74% of CFOs and finance leaders will move at least five percent of their previously on-site workforce to permanently remote positions post-pandemic.⁵ Engineering teams need to make remote collaboration an effective part of their normal operating routines, starting now.

By embracing the right technologies, medical device companies are not only investing in supporting their teams at this crucial time but also they are investing in the success of taking products to market, as the world conducts more and more business online.

References

“Case Study: Healthcare Leader Grifols Uses Jama Connect to Cut Costs and Speed Development”. (June 2019). Jama Software.
“FDA Relaxes Rules on Ventilators for COVID-19”. (April 2020). The Regulation Review.
“EU MDR: Parliament Overwhelmingly Backs One-Year Delay”. Regulatory Affairs Professionals Society.
“The Business Case for Medical Device Quality”. (October 2013). McKinsey & Company.
“Gartner CFO Survey Reveals 74% Intend to Shift Some Employees to Remote Work Permanently” Gartner, April 2020

Take a look at some of our other resources around collaboration that we’ve compiled for easy review here:
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