Six Reasons MedTech Contract Design Firms Thrive with Cognition's Compass® MED
requirements | design controls | Design | Compass MED | Contract Manufacturers
In today's rapidly evolving medical device industry, more companies and entrepreneurs are turning to contract design and manufacturing firms to bring their ideas to life. Managing multiple products, teams, and clients simultaneously is nothing new for these firms; however, the increasing complexity of products and immense pressure on time to market demands a more robust approach. That's where a centralized, structured data management and design control solution purpose-built for MedTech such as Compass® MED becomes essential, enabling firms to efficiently organize and analyze the multiple streams of information involved. Here are six key benefits of using Compass MED:
1. Structured Approach
Consider this: Would your firm benefit by following a systematic process for creating requirements? How often do incomplete inputs lead to missed outputs? Could having the right level of detail in all the right places save time?
Medical device development often involves using tools like checklists or spreadsheets to manage the complexity of products, from syringes to MRI machines. These tools help keep processes organized and ensure all steps are completed properly.
Compass MED simplifies this by providing a clear process for each stage of product design. It connects each step, starting with defining user needs, followed by creating design inputs and then moving on to design outputs while being able to link these items to create traces. This step-by-step approach helps turn an idea into a finished medical device faster.
By using Compass MED’s structured approach, teams can ensure that all the essential steps are in place, with documentation of user needs being traced to design requirements and outputs. The software captures details at every level, from high-level systems to raw materials and specific code. It also ensures that risk evaluation, testing, and design verification and validation are thoroughly completed, as you can read on our blog Rising Risk: Why Many Medical Device Companies are in Danger of Risk Analysis Missteps.
This structured approach not only streamlines the design process but also benefits contract design firms in multiple ways. It helps inexperienced designers learn best practices, maintains consistency with clients and across organizations, and assists larger organizations in refining their contract requests into actionable user needs and design input requirements.
2. Templates
Consider this: How often do you recreate similar document types that could be standardized with a common template and content structure? How much easier would it be if the same process is followed for each project, generating the same output document? Would it make it easier to close a project if you could ensure that deliverables are not missed or left unfinished?
Creating individual projects and documents for each client can take a lot of time and effort. Compass MED simplifies this task by providing project templates that come with pre-built documents, ready for reuse across each project. In a newly generated project, personalized documents are quickly set up, complete with the client's branding, allowing you to initiate their project faster.
These templates are also adaptable across projects. This streamlines the overall effort by eliminating the need to duplicate steps each time you start a new project.
3. Reuse
Consider this: How much time could your firm save by reusing data within a project while upholding confidentiality? How many errors could be avoided by reusing data? How beneficial would it be to reuse risk elements within the same organization or type of project? How much time is spent ensuring the same language is used within and between documents for the same content?
With the structured data framework (database structure) of Compass MED, reusing data is one of the key benefits, allowing for “change once, update everywhere” functionality. Within a project, a requirement can be connected to a mitigation as a control requirement, or referenced directly in a validation or verification test. By reusing the same data in multiple places, everything stays connected and can be easily cross-referenced. This helps users save time and work more efficiently throughout the design process by avoiding redundant data entry.
Compass MED also makes it easy to set up libraries for data reuse. For instance, a library with pre-approved hazards and harms provided by each client can be created. When doing a risk assessment, users can simply choose from these approved options. These risk libraries can be shared across an organization, so the same hazards and harms are available for multiple projects. Additionally, libraries of requirements from standards and regulations can be set up to support a compliant development process.
Using libraries not only simplifies data reuse but also reduces errors and ensures consistency in language across documents and projects
4. Collaboration
Consider this: Would it save your company time to have a client provide feedback instantaneously via informal or formal review? Would it be more efficient to have the client collaborate on requirements as they are drafted versus formal emails late in the process? How would it improve your processes to have risk incorporated early in the development and thus leverage best practices and company-specific knowledge effectively?
A good system of collaboration can make development smoother and more thorough. This way, contract design firms and their clients can effectively incorporate their areas of knowledge for risk and requirements early in development and continue throughout the process.
Your team needs to work closely with clients and each other to gather and use a variety of information. Compass MED allows groups to collaborate on their project within a single tool. Everyone with applicable permissions can create and add content to deliverable documents, and then easily review, approve, and release these documents within the system.
Clients can be set up to have access to a single project or a group of projects. And because Compass MED is a SaaS cloud-based application, access is available securely from anywhere, enabling collaboration and clear communication across various teams.
5. Traceability
Consider this: Have you ever reached the end of a project and realized that a requirement was missed in the development cycle and was not defined in the outputs or tested? How much time do you spend during audits proving that all inputs have been met? Are your risk mitigations all resolved when the project is delivered?
Tracing can often be the most time-consuming part of a project. You need to connect user needs with design inputs, design inputs with outputs, risk controls with requirements, and requirements with verification tests. That’s a lot of information to track, and in a Word or Excel-based process, it’s easy to make mistakes or miss important connections. When you add the different needs of various clients, tracing becomes even more complicated. Ensuring that all the connections are made, met, and resolved can feel overwhelming.
Compass MED’s real-time traceability handles this right out of the box. You can quickly make and review connections without spending hours manually creating traces or fixing errors.
As the project moves forward, Compass MED manages the trace automatically, ensuring user needs are met by the right requirements and outputs and accounting for any changes. It also highlights any missing connections and generates an auditable trace matrix for regulatory bodies. This provides clear visibility throughout the project, ensuring that all critical elements are properly addressed by the time you reach the end.
6. Compliance
Consider this: How do you know that your process meets the requirements of a particular regulation? How much time could be saved by having a guided process that meets both internal procedures and external standards and regulations? How do you know if your device will be able to withstand an audit and provide evidence that standards were considered and applied?
Medical devices must comply with strict regulatory oversight to ensure that products remain safe and effective during their lifecycle. Making sure devices comply with their standards and regulations can be a bit complicated without proper processes in place.
Compass MED provides the basis for establishing device design and validation compliance; it was specifically built to comply with design controls as defined by the FDA in 21 CFR 820 part 30 (aligned with the internationally recognized QMS standard ISO 13485 for design and development), with risk management standard ISO 14971, and with usability standard IEC 62366-1:2015. This helps your firm provide evidence to your clients of compliance with key regulations and standards, adding functionality that is complementary to your quality management system. It also means faster turnaround from that initial idea your client had to an approved product on the market, as we lay out in our blog post Seven Ways Compass MED Helps Speed Time to Market for Med Device Manufacturers.
In addition, Compass MED embeds a methodology to incorporate standards into each project, ensuring that critical elements are considered early and identified for updates when standards change. This bit of early planning helps steer development into a successful, compliant product.
CONCLUSION
Starting with a well-organized plan simplifies any process. Compass MED, a structured data management and design control solution for the MedTech industry, provides a strong foundation to ensure best practices are followed, helping you achieve product approval faster and more efficiently. With Compass MED, you'll not only optimize current projects but also simplify future ones by enabling easy access to historical data and maintaining consistent communication across teams. Compass MED can import from and connect to other software tools you currently use.
Compass MED ensures that all elements of the project are in their proper place, making connections clear for both your team and regulatory bodies. Simplifying the complexity of each client engagement makes the process smoother for both MedTech contract design firms and their clients—ultimately benefiting the patients who rely on these devices for valuable treatment.
