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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

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Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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Annual Report

2023 MedTech Industry Benchmark Report

A lot has changed since last year alone.

In our fourth annual medical device benchmark survey, discover insights from 600+ medical device professionals, and gain a better understanding of industry-wide trends, shifting strategies, commercialization challenges, and best practices that are shaping the medical device industry.

Download the full report

Top Takeaways

Focus across quality, product development, and executive teams has shifted toward compliance
Companies are misjudging commercialization timelines by 53%
MedTech professionals agree dynamic software tools will improve business outcomes

The Shift from Product Development to Compliance

2022 was the year of accelerating product development. This was due to the slowing down of the pandemic, which also resulted in optimistic revenue outlooks for the year ahead.


2023 looks much different. Teams across quality, product, and leadership are rallying around compliance and audit readiness. With revenue outlooks falling, companies are being more conservative about launching new products.

 

04

 

Expectations vs Reality for Medical Device Companies

Pre-market companies misjudge their commercialization timelines by over 50%. Early-stage companies are underestimating the importance of key activities for scaling operations such as hiring for manufacturing sites, training new employees, and engineering support that’s required. 

17

 

Using Technology to Fuel Efficiency

Over 50% of companies are not yet leveraging modern, purpose-built solutions. The majority are still relying on paper and spreadsheets to manage key product development, quality, and clinical activities. The good news is increasing investments in software solutions are on the horizon.

40%

still use paper 40% use paper to manage product lifecycle even though it correlates to lower performance

50%

investing in software 50% of pre-market companies are increasing investments in software solutions

2x

more successful 2x more likely to achieve quality & product development objectives in 2023

Areas for Improvement:
Quality & Product Development

With the industry-wide shift towards ensuring compliance, it is more imperative than ever that medical device companies are filling the gaps when it comes to establishing robust processes and enabling effective cross-team collaboration.

14

Design Controls & Risk Management

Challenges around documenting design controls and risk management processes persist across the industry. Keeping up with documentation and maintaining traceability continue to be top pains. Though the two processes are so closely related, it appears MedTech companies are using disjointed tools to manage them.
09-

Knowledge about Regulations and Compliance

There is a major opportunity for improvement in the medical device industry around understanding regulations and compliance requirements. To fill help these gaps, companies are investing in in-house training programs and different types of courses.

Invest in Your People
By Investing in The Right Technologies

MedTech companies are using on average 9 software tools to manage quality, product development, supplier, manufacturing, and clinical activities.

Having access to dynamic, modern tools is cited as the top solution for what would make jobs for MedTech professionals easier. Common pains experienced across Design Controls, Risk, CAPA, Supplier Management, and other key processes are eliminated as a result of adopting the right tools.

9

Software Tools Companies are using on average 9 software tools to manage product lifecycle.
2023 Survey Respondent “More than anything, I’d like a system that links everything - absolutely everything, like product documentation - together. It would transform my job.”
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So, what really happens when you invest in the right tools?

Change is constant in the medical device industry. We’ve seen some dramatic shifts between 2022 and 2023 alone. Across 600+ respondents, the most cited response when asked what would make the job easier was access to more modern software tools.

The Benefits:
  • 2x more likely to meet product development business objectives.
  • 50% more likely to meet quality and regulatory business objectives
  • 2x more likely to have excellent collaboration and access to real-time data with traceability
  • and more...
loopMark

How else can you set yourself up for excellence?

Download the full report to uncover the areas for opportunity in 2023.

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