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State of Medical Device Industry 2022

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2022 Industry Benchmark

State of Medical Device Quality, Product Development & Commercialization Report

The past few years have challenged the norm for medical device industries across the world.

In our third annual medical device benchmark survey, we gathered data from over 500 medical device professionals to better understand the industry’s growing market, opportunities for startups, and challenges that come with commercialization and supplier management. Read on to discover the latest insights on the challenges, strategies, and best practices that shape the medical device industry.

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Top Takeaways

The outlook for 2022 is overwhelmingly positive.
There are gaps in executing key quality processes and supplier management.
Market leaders outperform the rest in 5 key areas.

Who Took the Survey?

519 professionals in the medical device industry.

01@3x

 

The Year of Accelerated Product Development

Predicted growth in the industry is based on a few key drivers: A rebound in elective procedures as the pandemic wanes, an increased need for diagnostics in non-clinical settings (i.e., “anytime, anywhere” healthcare), and demand for products that integrate AI and machine learning.

Expectations for growth are high as markets are improving but there are roadblocks and uncertainty to achieving them. However, there are disproportionate efforts going towards product development vs. quality objectives as shown by the year over year data.

10@3x

09@3x

 

13@3x

Product Development Timelines Are Critical

Understanding where your medical device falls in relation to the rest of the market is a factor to success. Being realistic about funding, timelines, and time to market can help drive success for startups.

New Solutions for the New Normal

The 2022 study found that a majority of companies are not yet leveraging purpose-driven tools made for the medical device industry. In fact, a notable portion of companies are still using paper and spreadsheets to manage their eQMS.

1 in 3

still use paper even though they correlate to lower performance
loopMark

Areas for Improvement:
Quality & Supplier Management

Pre-market and commercialized medical device companies recognize a need for quality improvement related to product management. While the two critical processes go hand in hand, there are often disconnects seen between them that can ultimately lead to costly downstream impacts.

20@3x

Measuring Quality

Measuring quality initiatives is still a developing skill in 75% of pre-market companies. This brings to light a need for more professional education around those topics.
23@3x

CAPA Competence

Competence with CAPA is critical in being able to deal with systemic problems found during manufacturing.

Finding, addressing, and managing those problems long-term and understanding what documentation is required to overcome them is easier said than done.
3 out of 4

say their supplier management process is average or below average

Of that group, a majority are still using spreadsheets to manage their supplier information, storing their product management data in disconnected systems.
Potential Downstream Impact:

22% of those who were issued a warning letter took over 3 years to fully resolve.

The Impact of the Pandemic

Despite the pandemic’s continuous effect on supply chain processes across the globe, many medical device companies haven’t taken sufficient steps to mitigate the risks associated with suppliers.

What Respondents Had To Say

Response 1
Response 2
Response 3
Response 4
Response 5

COVID really revealed how risky we were behaving with very little supplier qualifications. We found many of our suppliers were also in much riskier positions than we thought.

Greenlight Guru Survey Respondent

With many innovative companies offering remote opportunities, it is harder for us to find suitable local resources.

Greenlight Guru Survey Respondent

Our biggest challenge is managing multiple 501(k) product development timelines and keeping track of everyone's assignments.

Greenlight Guru Survey Respondent

Our supplier management system was fairly recently overhauled. We have a lot of legacay suppliers that we are struggling to bring up to current standards ... and having difficulty finding replacement suppliers. We also generally only have one supplier for every part.

Greenlight Guru Survey Respondent

What worries me the most? Meeting expectations of upper management, especially aggressive timelines designed to please investors.

Greenlight Guru Survey Respondent

The Lasting Effects of Virtual Work

The Positives and Negatives

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2022 Recipes for Success

The medical device industry is evolving faster than ever and it can be difficult to keep up. This report brings the secrets of success to light.

So, what are the 5 things that leaders in the medical device industry doing differently? 
  • 75% of market leaders invest in in-house training programs for their employees to stay up to date on industry information.
  • 67% view quality as an asset- meaning, tightly aligned company goals, with accountability and quality injected into every initiative.
  • and more...
loopMark

How else are market leaders paving the way?

Download the full report to uncover the 5 key areas to focus on in 2022.

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