In-vitro Diagnostic Equipment


Project: In-vitro Diagnostic Equipment

Client Need:

  • Deliver multiple concepts for a new family of lab instruments
  • Help build a blood culture and detection device as the new cornerstone product offering for the client
  • Build upon the client’s predicate device and help sustain the product

How RBC Added Value Concept:

RBC provided concepts ranging from thermal and motion control models to a series of group concept prototypes including incubation, sample handling, motion control and vial dispensing. We considered different levels of automation and capacities, and conducted proof-of-concept experiments.

Development Challenges

The predicate device for this project is a legacy product with parts obsolescence risk and sustaining engineering challenges. This effort became two-fold: Build the new products upon the very successful predicates while continuing to maintain production and supply of those predicates.

For our portion of the Blood Culture Detection project, RBC handled:

  • Circuit board and cabinet design: The electrical engineering of the board and designing the compartment into which it would be placed.

  • Automation control designs: The process by which samples move through the platform and deliver blood culture detection results.

The device is a major product advancement for this client. The new product has four times the sample capacity of its predecessor, is better integrated with customer systems, uses floor space more efficiently, and is far more intuitive to use all in a very attractive package!

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Client Comments

The client’s Senior Director of R&D on this project had this to say about RBC:

“My relationship with RBC spans 15+ years and 3 medical care markets. I return to RBC again and again because they deliver innovations in a timely and cost-effective manner. I plan to continue this relationship for many years to come!”

In fact, we’re working with him now at his new home, a top medical device manufacturer.

510(K), PMA, AND CE MARK SUBMISSIONS
Depending on your needs, RBC Medical Innovations can produce all or part of the design documentation required for a FDA 510(k) submission, pre-market approval, or a CE Mark technical file.