Case Study – Development of a Class 1 FDA Medical Device

Case Study – Development of a Class 1 FDA Medical Device

To align the right product to the right market requires a bridge of well vetted information and data. Zenos was able to help construct that bridge for my company while developing a class 1 FDA medical device – a specialty wheelchair cushion. Creating such a bridge was not only invaluable, but also strategic to help define the right milestones to set at the right time.

The scope of Zenos’ work was largely research. They began by investigating market product data: features, styles, pros/cons. Existing manufacturers, distribution, and supply chain channels were explored, along with current pricing structures. Zenos not only provided this data, but also the right point of contacts within these networks to be able to progress with partnerships.

Next, the research moved to user-specific data. They provided global and international statistics, along with the number of potential customers and market insights.

Once a clear needs assessment was completed, Zenos also helped supply information regarding regulatory and FDA requirements. Furthermore, ISO and testing requirements were also researched and provided.

Zenos then investigated United States based testing laboratories and clinical research organizations available to help with qualification and market entry. They were even so kind as to reach out to these organizations to determine capabilities and vetted them personally.

While at the time of this writing we are in the engineering design phase, we have a clear path forward to our future customers thanks to Zenos.

The information and market data Zenos provided for this project has been invaluable. I consider them not just an administrative support service, but a real strategic business partner.  They will help you to do what you do best, while saving you countless hours in the process.  Beyond all this, they are excellent communicators ensuring alignment is created between their service and your need for each step of the way.

As an owner of a multi-business enterprise, I will continue to work with Zenos and their team on future projects.

Clarion Solutions Group / Goal Manager LLC

Wes Anderson

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