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