Survey of 100 medical device manufacturing executives and engineers reveals all are seeking to get to market faster, yet most are overlooking a key lever for acceleration
Baltimore, MD, June 3, 2024 – Sage Growth Partners (SGP), a healthcare growth strategy and marketing firm, has released a new report focused on the top product development challenges and opportunities that medical device manufacturers are facing.
As medical device manufacturers attempt to successfully navigate the design control process—including requirements management, risk management, and test management—they face significant pressure to develop successful devices quickly. At the same time, they are creating increasingly complex devices while balancing evolving industry standards and regulations.
To better understand these difficult dynamics and how they are impacting medical device manufacturers, Cognition Corporation®, a leading provider of product development and compliance solutions for the life sciences industry, commissioned Sage Growth Partners to survey 100 medical device manufacturing executives and engineers in Q4 2023.
This report contains the survey findings, including a closer look at medical device manufacturers’ top priorities and challenges. It also identifies, based on an analysis of the survey data, an underutilized lever that is helping leading manufacturers accelerate their time to market, without sacrificing safety or quality.
“While medical device manufacturers are extremely innovative, it’s surprising that many continue to rely on outdated, manual processes for design control,” said Dan D’Orazio, CEO, Sage Growth Partners. “Our analysis of these survey findings reveals that transitioning to a design control solution would help many medical device manufacturers overcome critical challenges, enhance risk management, and drive significant efficiencies.”
Key survey findings highlighted in the report include:
- The top ranked priority among medical device manufacturers is “reducing product time to market,” while the top ranked challenge is “resource limitations.”
- Only 24% of surveyed respondents said their organization has completely eliminated manual design control processes (i.e., Excel, Word, or paper) and has fully transitioned to a design control solution.
- Those that have fully transitioned to a design control solution are experiencing significant advantages over those that have not. These include:
- Higher satisfaction with documentation management processes (65% that use a solution are satisfied compared to only 41% that use a manual approach).
- Higher satisfaction with test management processes (53% that use a solution are satisfied compared to only 36% that use a manual approach).
- Higher satisfaction with risk management processes (67% that use a solution are satisfied compared to only 38% that use a manual approach).
- Those that use a design control solution also report stronger integration across key domains, including requirements management, risk management, and test management (62% that use a solution report their processes integrate extremely well compared to just 17% that use a manual approach).
“When it comes to medical device development, the opportunities are endless yet the pressure to innovate quickly is extraordinary,” said Gerald Wesel, Chairman and CEO, Cognition Corporation. “The medical device manufacturers that emerge as industry leaders over the next few years will leverage automation and integration to enhance efficiencies, reduce risks, and enhance data integrity throughout the design control process.”
A complete copy of the report and survey findings is available online.
About Sage Growth Partners
Sage Growth Partners is a healthcare growth strategy and marketing firm with deep expertise in market research, go-to market strategy, and marketing communications. Founded in 2005, the company’s extensive domain experience ensures that healthcare organizations thrive amid the complexities of a rapidly changing marketplace. Sage Growth Partners serves clients across the full healthcare spectrum, including GE Healthcare, Medecision, ProgenyHealth, Kyruus; Best Buy Health, New Jersey Brain and Spine, the National Minority Health Association, and Philips Healthcare. For more information, visit sage-growth.com.
About Cognition Corporation®
Cognition Corporation specializes in product development and compliance solutions for the life sciences industries. For medical device professionals, Cognition offers a design controls software platform that helps meet regulations faster with real-time traceability, guided design controls, and change once, update everywhere functionality– turning manual and disconnected data into structured submissions that enable them to get to market faster.
Unlike other design controls solutions that simply replicate traditional documents and spreadsheets, Cognition takes a structured data approach combining risk with test and requirements data so you can easily build relevant connections between data items, automatically create complex trace matrices, allow a single item to be reused in many different projects as well as many places within a single project, and export formatted documents instantly offering a more efficient and integrated solution. We are shifting the data management landscape for medical device and pharmaceutical product development from a static, document-based approach to a dynamic, information-driven approach helping to streamline and alleviate the administrative burden of product development documentation. Further information about Cognition Corporation can be found at www.cognition.us.
