MedLaunch:
Revitalizing a Legacy Medical Device
In a rapidly evolving medical device landscape, MedLaunch, a specialized consulting firm, was approached by a small startup facing a unique challenge. The startup had recently acquired a medical device line that was on the verge of discontinuation due to backorders and planned obsolescence.
The mission was clear: transition ownership, achieve market authorization in the US, EU, and UK, and relaunch the product, all within a tight timeframe to ensure continuous patient access.
Client Background
The client, a nimble startup in the healthcare sector, recognized the untapped potential of the legacy medical device. However, they lacked the regulatory expertise and resources to navigate the complex process of international market authorization.
Challenge
The primary challenge was the tight timeline. The device, although valuable, was on the brink of discontinuation. Any delay in the transition and authorization process could lead to a gap in market availability, affecting patient care.
Solution by MedLaunch
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Review and Gap Analysis: MedLaunch initiated the project with a thorough review of the existing technical documentation and regulatory findings of the device. This helped identify critical gaps that needed addressing for compliance in different markets.
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Strategic Planning: A comprehensive plan was developed to transition the ownership of the device to the client efficiently.
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Quality Management System (QMS) Establishment: Recognizing the importance of quality assurance, MedLaunch established a robust QMS tailored to the startup's operations.
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Technical Documentation: The team worked meticulously to close the gaps in technical documentation, ensuring it met the stringent standards of different regulatory bodies.
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Regulatory Submissions and Liaison: MedLaunch filed regulatory submissions and actively worked with government agencies and authorized representatives across the US, EU, and UK.
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Local Government Registration: The client's manufacturer status was registered with the relevant local governments, fulfilling an essential compliance requirement.
Results
In an impressive turnaround of less than six months, MedLaunch not only managed to keep the legacy device from discontinuation but also achieved market authorization in three key regions. The product was successfully launched in the US, EU, and UK. This rapid execution ensured uninterrupted patient access to a vital medical device and opened new market opportunities for the client.
Conclusion and Learnings
This case study demonstrates MedLaunch's expertise in regulatory navigation, strategic planning, and swift execution. The success of this project highlights the importance of a well-coordinated approach to regulatory compliance and market entry. MedLaunch's ability to fast-track such a complex process without compromising on quality or compliance sets a new benchmark in medical device consulting.
Come work with us.
MedLaunch continues to be at the forefront of medical device consulting, offering comprehensive solutions for market entry and compliance. If your organization is looking to navigate the complexities of medical device regulations, contact MedLaunch to ensure your product's success in the global market.