The Medical Device Product Development and Quality Management Benchmark Survey had over 500 participants, with the majority of respondents focused on quality, regulatory, or product development at companies with 25 to 249 employees with a mix of end markets devices are being sold into, but mainly focused in the EU (64%) and the US (62%).
In the fast-paced, ever-changing environment of the medical device industry, companies face both organic and self-inflicted challenges in bringing new devices to market and managing quality throughout the device lifecycle. To better understand these challenges, we asked product development and quality teams what specifically was holding them back.
For product development teams, common barriers to improving the product development process are a shortage of resources (55%), and insufficient budget (37%).
A lack of management buy-in was also a problem for more than 1 in 4.
For quality professionals, a key barrier to improving the quality system and processes is driven by leadership not allocating the budget necessary for improvements.
Quality leaders also noted the perceived cost of validating new tools or processes and internal resistance to change as common challenges.
The unique challenges experienced vary by role. When we examine the perspectives of those working in quality versus product development, interesting differences emerge as it relates to the specific challenges in improving processes.
A key marker of operational excellence and efficiency is how well medical device companies are prepared to face unannounced audits and pending regulatory changes -- and on this front, the research shows preparedness (or lack thereof) is a critical concern for many.
3 out of every 4 medical device professionals indicated that they would not be very confident in their ability to pass an unannounced audit by the FDA or Notified Bodies.
Unsurprisingly, being ready to comply with the requirements of EU MDR that go into effect in 2020 is a challenge for many in the industry, with nearly 80% of respondents indicating they are not ready for the impending EU MDR transition.
Reminder: EU MDR goes into effect in May 2020!
While closed-loop traceability (CLT) is revolutionizing aspects of product development, manufacturing, quality, and compliance activities, over half of respondents answered they currently cannot demonstrate CLT.
Those that can currently demonstrate closed-loop traceability are much more likely to say they are confident about passing unannounced audits.
It is no surprise to experienced medical device professionals that the use of legacy systems and tools still dominate the industry — across design, quality management, and risk activities. While these solutions may save money short term, long term these ad-hoc systems create tremendous (and costly) inefficiencies, as well as introducing both patient and business risks.
For many industry professionals, the use of these legacy tools creates challenges in effectively collecting and managing quality data, with 2 out every 3 respondents indicating the data collected by their company's quality system is not easily accessible.
Additionally, nearly 60% of respondents indicated the data generated by their quality system is not consistently reliable.
The companies using best-in-class tools are 2x more likely to be very confident in their ability to pass an unannounced audit than the companies currently using legacy tools.
For the industry’s top performers, quality isn’t just a buzzword — it’s a cultural value.
“Quality-as-an-Asset” means building quality into every stage of the organization, from device design and development to sales, manufacturing, and post-market surveillance.
Companies that view quality as a strategic asset are 2x as likely to be able to demonstrate closed-loop quality traceability and consider themselves highly competitive in their respective markets.
These companies are also more likely to use best-in-class, industry-specific, tools than industry laggards that are not quality-focused.
Almost half (46%) of organizations that say they are highly competitive in the marketplace are investing in best-in-class tools (AKA - not using legacy tools).
Half of organizations that consider themselves to be highly competitive say their data is consistently reliable, with another 45% saying their data is somewhat reliable.
Achieving Closed-Loop Traceability is one of the best tactics when it comes to ensuring quality. Organizations that embrace CLT are far more likely to consider themselves highly competitive.