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top takeaways

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Critical benchmarks and the impact of COVID-19 on the industry

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Signals from market leaders to elevate competitiveness

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4 Ingredients for success in 2021

WHO TOOK THE SURVEY

Results from the 2021 Medical Device Product Development and Quality Management Benchmark Survey were driven by over 300 global participants, of whom are employed in engineering, quality, regulatory, and operational roles by organizations ranging in size from small to enterprise level.

 

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CRITICAL INDUSTRY BENCHMARKS

The current health crisis has impacted medical device companies and served as a catalyst for quality and product development improvement while revealing insights into current challenges and inefficiencies. We set out to understand their approach to technology, risk management, process improvement, and just how they are overcoming the pandemic.

Weathering the COVID-19 pandemic

The COVID-19 pandemic has buoyed the fortunes of some medical device companies due to spikes in demand. 

For others, the crisis has largely wreaked havoc on supply chains and revenue projections.

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GRASS LOOKS GREENER ON THE OTHER SIDE

Looking ahead, the picture appears to be more favorable in 2021.

Medical device companies expect modest-strong revenue growth, and very few expect revenue shrinkage.

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NAVIGATING A DIGITAL WORLD

Remote teams are relying heavily on storing and accessing documents on a shared network (3 in 4 report doing this) or accessing files under some type of document control (59%).

This introduces new, significant risks around access, security challenges, and operational efficiency.

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COMPETING POINTS OF VIEW

Company leadership often has different focus and expectations vs. managers and individual contributors — and these differences can lead to additional risk, as well as affect job satisfaction.

WHAT RESPONDENTS HAD TO SAY

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The Tech Advantage

While technology is never curative, the right tools do give companies a significant advantage.

Similar to last year’s findings, tech maturity remains stubbornly low in the industry with roughly half of all respondents say they use general-purpose tools to support design control and risk management processes (53%) and for quality management processes (49%).

The research points out the specific benefits that specialized technology for the medical device industry offers the companies that deploy it.

MARKERS OF EFFICIENCY

Regardless of quality or total risk, how efficient are internal processes that oversee these?

144 hours 

is the average time it takes to compile a Design History File.

31%

say it takes 2 days or more to update a traceability matrix.

Only 13% can do so in less than one hour.

1 in 4

say that documenting closed-loop traceability (CLT) requires “substantial effort.”

Just 28% can document CLT in real-time.

4 INGREDIENTS THAT BUILD A QUALITY CULTURE

To join the ranks of high-performing companies in the medical device industry, we see four key areas for medical device companies to focus on in 2021 and beyond.

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SIGNALS FROM MARKET LEADERS

 

 

How are highly competitive companies outperforming their peers? The research uncovers what these best-in-class organizations are doing differently.

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4x more likely to forecast strong revenue growth in 2021.
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40% begin documenting design controls in a traceability matrix during concept and feasibility.
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1/2 ensure fully integrated risk management into the QMS throughout the product life cycle.
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2x more likely to leverage traceability for impact analysis.
   
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QUALITY AS A STRATEGIC ASSET

Quality is no longer a “checkbox” activity, but a key generator for competitive strength. High performing companies view quality as a tactical advantage and a mindset that influences best-in-class product development and product improvement - while outperforming their peers.

 

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