Taking The Lead in the Race to Market
The 2024 Medical Device Manufacturer Report
A new survey of 100 medical device manufacturing executives and engineers reveals that many are overlooking a key strategic lever that can help them safely accelerate their time to market.
Overview
Medical device manufacturers face significant challenges in today’s $595 billion medical device market. The pressure to develop successful devices quickly is extraordinary. At the same time, medical device manufacturers are creating increasingly complex devices, amidst a backdrop of evolving standards and regulations. As a result, successfully navigating the design control process, including requirements management, risk management, and test management — at speed — is becoming extremely difficult.
In Q4 2023, Cognition Corporation, the leading provider of design control solutions specifically engineered
for medical device manufacturers, commissioned Sage Growth Partners, a research and strategy consulting firm, to conduct an independent survey of 100 medical device executives and engineers. The goal: To better understand the impact of these challenging conditions and identify whether transitioning to a design control solution can help manufacturers enhance safety and quality while accelerating time to market.
This report outlines the findings.
Executive Summary of Key Findings
What is a design control solution?
A design control solution automates and integrates processes across requirements management, risk management, and test management. This is often referred to as a “modernized approach” for design control, since a large majority of medical device manufacturers still rely on manual processes (such as Excel, Word, or paper) for managing design control processes. Benefits of a design control solution include automated trace matrices, stronger integration and collaboration, a single source of truth, and submission-ready documents.
How many organizations have transitioned to a design control solution?
The vast majority of manufacturers continue to rely on manual processes, or a mix of manual processes and design control solutions, according to the survey findings. Overall, the survey found that only about one-quarter of the medical device executives and engineers have completely eliminated manual processes and fully transitioned to a design control solution.
What are the findings related to the value of a design control solution?
The survey set out to ascertain whether transitioning to a design control solution can help manufacturers safely accelerate time to market. In order to evaluate the technology’s potential impact, Sage Growth Partners grouped the survey responses into three categories based on respondents’ self-reported design control processes (manual, a mix of manual and a design control solution, and a design control solution only).
A comparison of responses across these groups found that manufacturers that rely on a design control solution are experiencing significant advantages.
Only 24% of manufacturers have completely eliminated manual processes and rely solely on a design control solution.
What are the advantages of a design control solution?
Fewer challenges with critical elements of the design control process
— including less difficulty with managing the design with managing the design history file (DHF), with risk analysis, with audit readiness, and with change management.
Much higher satisfaction with how their organization manages critical design control processes
— including documentation management, test management, and risk management.
Stronger integration across key design control areas and domains
— including requirements management, risk management, and test management.
A Deeper Dive into the Data: Medical Device Manufacturers’ Top Priorities and Challenges
Prior to sharing more of the survey findings about the advantages provided by a design control solution, it’s first important to explore the overall findings related to manufacturers’ top priorities and challenges. The survey revealed that most manufacturers are highly focused on accelerating time to market while ensuring a high-quality design and regulatory compliance. When it comes to manufacturers’ top design control challenges, responses ranged from ensuring audit readiness to managing the DHF. Overwhelmingly, however, resource limitations ranked highest, with nearly 70% of respondents indicating it is a top challenge. Nearly half of respondents also stated that their organization struggles with siloed data and with helping their teams adjust to new processes or operational changes.
Biggest Areas of Concern: Significant Room for Improvement Across Key Areas
Most medical device manufacturing executives and engineers indicated that their organization has less than optimal practices across critical areas: documentation management, test management, and risk management. In total, only about half of all survey respondents said they are “very satisfied” with their current practices within these areas.
How satisfied are you with your organization’s current practices for:
How well do your current design control processes integrate across key domains?
The findings also reveal that most medical device manufacturers are struggling to integrate data and workflows across key domains (such as requirements, risk, and test management). In total, nearly 70% said their current processes either don’t integrate well or only integrate moderately well.
For many, that lack of integration may be contributing to concerns related to the integrity of data. Overall, the survey found that:
Only 10% of respondents are extremely confident in the integrity of data associated with the DHF.
Only 8% are extremely confident in the integrity of data associated with audit readiness.
Only 7% are extremely confident in the integrity of data associated with risk analysis.
Traceability Troubles
Traceability — the ability to link requirements to user needs to risks, and so on — is a critical aspect of design control. Only about half of respondents (51%), however, report high satisfaction with their current traceability practices.
A Winning Strategy for Overcoming Challenges & Concerns: The Optimal Approach for Design Control
As noted in the executive summary, a comparison of survey findings based on respondents’ self-reported design control processes found that those that have completely transitioned to a design control solution are experiencing significant advantages. Overall, 30% of respondents still rely on manual processes, 38% rely on a mix of manual processes and a design control solution, and 24% rely on a design control solution only.
A Critical Consideration: Not All Design Control Solutions are Equally Effective
Clearly, a design control solution can help medical device manufacturers overcome critical challenges and enhance processes across key areas. Yet there are several design control solutions on the market, and not all are purpose-built for medical device development that drives optimal results. In fact, while the comparison of survey findings shows that design controls solution provide significant advantages over manual processes, it also shows that, in some instances, there’s still room for improvement.
For example, only 53% of respondents that use a design control solution stated they are satisfied with their test management processes. While this is much higher than the 36% of respondents that use a manual approach, it’s still not ideal. Another example: While 62% of respondents that use a design control solution said their processes integrate well across domains, 38% said they only integrate moderately well or not well at all.
In order to experience the full positive impact of a design control solution, manufacturers should seek out solutions specifically designed to satisfy the needs of complex medical device design, rather than a general solution product that has been created to serve multiple industries. Medical device specific solutions are developed with a deep understanding of the various needs, inputs, and outputs required; system requirements; the specific standards and regulations, and more. As a result, these solutions are much more intuitive and efficient for medical device manufacturers, providing filterable data and submission-ready documents specific to their needs.
of survey respondents stated that a consolidated solution for design control data, test data, and risk management data would be valuable to their organization.
A Significant Traceability Advantage
As noted, only 51% of all survey respondents report high satisfaction with their current traceability practices. For respondents representing organizations that use a manual approach for design control, that percentage dips to 41%. Among those that use a design control solution, that percentage increases to 65%.
Additional Critical Considerations and Capabilities
For test management and integration capabilities specifically, medical device manufacturers should seek out a solution that can incorporate different levels of tests that combine full protocols with multiple methods, design verification, and validation. This level of support will enable the verification of inputs and the validation of user needs. Within the solution, tests should not only connect to requirements, but also connect to risk.
Medical device manufacturers should also look for a solution that is adaptable both to best practices and to their company’s unique standard operating procedures and process. The solution should be flexible enough to accommodate the company’s growth and history, and it should support various processes for different groups or business units. That way, each department 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 the organization.
Critical Capabilities to Seek Out
Many device design control solutions overpromise and underdeliver, supporting general device development needs but failing to address the unique needs of medical device development companies.
If your organization is seeking a design control solution, be sure to prioritize a solution that:
To learn more about key capabilities to seek out, read:
How to Identify an Effective Medical Device Design Control Solution: 9 Key Considerations.
Powering Accelerated Design Control: Compass® MED by Cognition Corporation
Compass MED by Cognition combines more than 20 years of experience dedicated to the medical device industry for a solution that is known for its ability to enhance efficiency, collaboration, and quality throughout the design control process. With Compass MED, all data is structured with a unique identifier allowing the reuse of data items throughout projects. This allows for change once, update everywhere capability so when you update an item in one location you can be confident it updates in all locations.
The solution supports the creation and maintenance of deliverables or artifacts used for both submission and internal review. Users can access full audit logs for all documents, as well as visibility into changes within each document section. Furthermore, the solution offers seamless support of both a data-centric workspace for engineers and a document-centric environment for easy regulatory submissions, allowing users to work in the environment they are most comfortable in.
With Compass MED, comprehensive risk management is fully incorporated — in a flexible and customizable way — to ensure compliance with all relevant risk standards throughout the design control process. Compass MED also enables organizations to easily import data from other systems, easily integrate with other systems, and scale up incrementally, based on the organization’s unique timeline and needs. Compass MED is available as both out-of-the-box and highly configurable workflows to meet each manufacturer’s unique needs.
Methodology
The survey of 100 medical device manufacturing executives and engineers took place in Q4 2023. Respondents represented OEMs (48%), startups (39%), and contract design and/or manufacturers (13%). Nearly all respondents resided in the U.S. (98%), and most said their products were marketed in the U.S. (94%).
