Case Studies

CASE STUDY: 510(k) Gets Investor Funding

A tight timeline to secure funding

A 510(k) for a Software as a Medical Device (SaMD) is a vital part of the path to commercialization. But so is investor funding. When given a short timeframe by investors to build its 501(k) and receive operating funds, this company couldn’t do it on their own. How did MethodSense help them achieve success?

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De-risking the path to market.

Improving compliance for any therapy ultimately improves results. So, when an emerging company developed a pediatric implant for parent/caregiver compliance, the potential for positive patient outcomes (and company profit) was huge. But when the FDA’s regulatory pathway seemed impossible to navigate, MethodSense helped find a way to FDA approval. How did they minimize their risks on the journey to success?

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Expanding success into the U.S. market

With 100 years of business success in the European market, a combination product company with a novel technology was almost thwarted from enlarging its market into the U.S. because of 510(k) deficiencies per the FDA. With help from MethodSense, this strong company and its pharma partner are enjoying fast-growing market share—and profits—in the States.

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Creating a no-intimidation audit.

When an emerging Class II medical device manufacturer was given just seven days’ notice for an FDA audit, panic naturally ensued—especially since documentation hadn’t been a priority for them. But with help from MethodSense, the audit process became highly manageable and less daunting for the company. How were they able to move forward in confidence?

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