How to Identify an Effective Medical Device Design Control Software Platform: 9 Key Considerations

Critical software functionality for every medical device development company

Medical device development companies are increasingly recognizing the value of a purpose-built medical device design control software platform for delivering safer products to market faster, with less risk and less cost. Robust documentation processes, provided via an effective software platform that supports audits and more, ultimately lead to higher-quality products.

But not all device design control software platforms are equally effective. In fact, over the past year, we’ve seen an uptick in demand among organizations that are seeking to transition to a purpose-built medical device design control software platform, like Compass. For most of these organizations, their current platform is failing to deliver a robust design, inherent high quality, and submission ready, accurate, regulatory documentation.

The consequences of selecting an ineffective platform are severe. They include inefficiencies, wasted resources, safety and quality missteps, and frustrated teams—just to name a few. Medical device companies simply can’t afford to make the wrong choice.

So how can your organization ensure it is selecting an optimal platform? To help, we’ve identified nine critical attributes to seek out.

Attribute #1: Specifically Engineered for Medical Device Companies

Seek out a platform that has been designed specifically to satisfy the needs of complex medical device design, rather than a general purpose product that has been created to serve multiple industries. Medical device specific platforms are developed with a deep understanding of how medical device development works; the various needs, inputs, and outputs required; system requirements; the specific standards and regulations, and more. As a result, these platforms are much more intuitive and efficient for medical device developers, providing filterable data and submission-ready documents specific to their needs.

Attribute #2: Enables Highly Configurable and Adaptable Processes

The goal of a robust medical device design control software platform system is to foster constant process improvements. Therefore, the platform should be adaptable both to best practices and to your company’s unique standard operating procedures and process. Rather than requiring you to change your established process to fit its design, the platform should be flexible enough to accommodate your company’s growth and history. The platform should also support different processes for your different groups or business units. That way, each group or business unit will have its own unique processes that are tailored to their specific needs (e.g., risk processes), yet they will also still be able to access and share common libraries across your organization.

Attribute #3: Provides a Flexible Work Environment for Different Design Definition Approaches

Most software available for medical device development use a data centric approach with tables and forms to view the data. Data is entered without concern for document format or export, keeping focus on the specific area the user is responsible for completing. However, these platforms often fall short when it comes to exporting the documents required for an audit or regulatory submission. The tabular data and a document template are merged as part of the export process. Since the content of the full document isn’t edited within the system, the document tends to require additional editing post-export. Therefore, the final document and the data within the system can become misaligned, and in some cases the data is changed in the document and not in the data system. When systems provide both document centric and tabular data centric approaches, documents can be fully authored and edited within the platform. This enables the same control to be applied to the design critical input and output data as is applied to the rest of the document content. Being able to manage both documents and tabular data in the same design control software platform allows all of these items to be controlled by review and approval workflows and ensures quality and regulatory teams are always working with the most recent, accurate data.

Attribute #4: Supports Optimal Risk Analysis Processes

Managing risk is more critical, and more complex than ever—and not all platforms are keeping up. When evaluating platforms, it’s critical to ensure they have deep and broad risk management functionalities, including distinct risk analysis and FMEA processes with seamless data exchange. The platform should also support:

• Multiple risk standards and company specific risk processes through configurations (ISO 14971, IEC 62366, IEC 60812).
• Multiple risk and reliability approaches that are built-in to the software or that can be added through configurations (such as preliminary hazard analysis, product risk analysis, multi-level design FMEA, use error analysis, software FMEA and pFMEA).
• Harm and hazard libraries that are integrated within the system for use across the organization or by product line.
• Tight integration between risk, tests, and requirements, illustrating controls/mitigations and linking between elements. 
• A templated approach to risk management, guiding the user with simple questions and using the answers to populate risk analysis tables.
• Data sharing across supporting tools creates a seamless risk management system where sequences originating in both normal and fault conditions can be assessed in a single risk analysis.

To learn more about these risk-related capabilities, and others to seek out, read “Rising Risk: Why Many Medical Device Companies Are In Danger of Risk Analysis Missteps.”

Attribute #5: Supports Seamless Data & Document Sharing

The platform should foster deep collaboration between your core teams, including those focused on requirements, risk, and testing. Seamless collaboration will ensure that all of your teams are working together toward a common goal, which will improve the quality of the final product and reduce the risk of errors or defects later in the development cycle.

Attribute #6: Provides Optimal Test Management Capabilities

Seek out a platform with the ability to incorporate different levels of tests that combine full protocols with multiple methods, design verification, and validation. This level of support will ensure you can verify inputs and validate user needs. Within the platform, tests should not only connect to requirements, but also connect to risk.

Attribute #7: Offers Real-Time Data Traceability

Real-time data traceability saves significant time during the device development process and enables your team to instantly create, view, and manage traces wherever and whenever they are needed. With real-time data traceability, as you are collecting all the data, creating all of your requirements, risks, and tests, and building cascades and links within the platform, you will also be simultaneously creating traceability. You will be able to view trace tables at any time, and this information can be used for audits, impact analysis, design reviews, and other activities, without additional effort to maintain.

To learn more about real-time traceability, read “How Medical Device Companies Can Leverage Real-Time Traceability to Speed Up Development, Increase Accuracy.”

Attribute #8: Supports a Streamlined Training and Implementation Process

Transitioning to a new platform should not slow your company, or your development team, down. Seek out a platform that can be implemented very quickly and that requires minimal training. In fact, the most effective platforms provide training programs that can be completed in a matter of hours. Also look for a platform that:

• Provides everything you need, off the shelf, for requirements, risk, and test management;
• Includes built-in templates and work instructions to guide users; and
• Requires only a couple of days to configure to meet your company’s specific SOPs.

Attribute #9: Has a Simple Implementation Process

When selecting a new platform, there should be a straightforward, quick, and easy implementation process that includes the importing of data from existing separate systems (e.g. word, excel, etc.) and integration of other data (e.g. Jira, etc.). The platform should support multiple formats, from XML or CSV to API transfer or other formats. Whether you are seeking to migrate data into a new system, exchange information between systems on an ongoing basis, or help everyone understand and use the software, you should seek out a platform provider that is a true partner and not just another supplier.

How Compass Can Help

Compass, a medical device development platform provided by Cognition, is a pre-configured, out-of-the-box, SaaS solution purpose-built to connect data across all functional areas of medical device product development, leveraging regulations such as 21 CFR 820.30 as well as standards ISO 13485, IEC 62366, and ISO 14971 as the foundation of the software design.

Compass users experience the following benefits:

• Faster time to market with fewer resources—without sacrificing safety or quality
• Faster development time, with automated processes that ensure data integrity and timely and efficient completion of project activities
• Tightly integrated risk management, requirements management, and test management to enhance risk management and improve efficiencies

For companies that are ready to transition to Compass, we provide resources that enable a highly integrated and seamless transition, for both importing your existing data from separate systems and onboarding users, all within a few days. Click here to learn more about Compass.