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Case Study

Sedation Systems’ Miniscav

By October 5, 2022December 7th, 2022No Comments

This Class II Medical Device was developed to pair with Sedation Systems’ Nitrous Analgesia system. The product is designed to safely remove exhalant and excess nitrous from the environment by emptying it into a sink drain through the Vent Connector. The product was designed to meet the FDA’s requirements for scavenging, and fabrication and assembly was sourced in the United States at an FDA approved facility.

Sedation Systems’ Nitrous Analgesia system allows doctors across specialties to administer Nitrous Sedation for in-office procedures. However, chronic exposure to Nitrous Oxide presents a risk to care providers. To address this risk, Sedation Systems partnered with Emergnt to develop a solution.

DEFINING REQUIREMENTS

The product had to meet the following criteria:

  • Meets AAMI/ANSI/ES60601-1 Standards for electrical safety
  • Provides a constant vacuum of <= 90 mmHg at a constant flowrate of 42 L/m in accordance with FDA regulations.
  • Compatible with Sedation Systems’ Analgesia system, flowmeter, and Vent Connector.
  • Designed within the limits of an existing 510k.
  • Be assembled in an FDA-approved manufacturing facility.

DESIGN PROCESS

Mechanical-Engineering
Our Mechanical Engineers analyzed an existing product, which Sedation Systems had been using for scavenging previously. Upon discerning that this product met the design requirements, our team reverse-engineered the device.
Our team developed 3D CAD Models of the new product. In this phase, off-the-shelf components like the internal pump and the fastening hardware were spec’d and modeled. Custom components, like the enclosure and the water trap, were designed to house and interface with the stock components.

A rendering generated from the 3D CAD Models of the Miniscav.

Our Electrical Engineers designed the electrical and power system for operating the Miniscav. Our team analyzed the previous design to ensure that it met the safety standards outlined in the requirements. Then they spec’d off the shelf components and hardware and created a wiring schematic for production partners to follow during assembly.
Production-Drawings
Following a design review with Sedation Systems and their approval, our engineers drafted Production Drawings based on the 3D CAD Models. These files detailed the Product & Manufacturing Information (PMI) and would be the primary reference for production. The files included dimensioned drawings, flat patterns, an assembly drawing, and a BOM.
Production-Sourcing
With these files, our team Sourced Production for the device. In accordance with the requirements, our team engaged with multiple FDA-approved facilities. We coordinated with Sedation Systems’ FDA consultant on the other regulatory requirements for the production facility.

After a short, 4-month design process, Emergnt presented Sedation Systems with an acceptable proposal from a FDA-approved manufacturing facility. Emergnt handed off the conversation to Sedation Systems to manage the proposal negotiations, but stayed involved for further design and prototyping points.

Through this short process, Emergnt gave Sedation Systems complete control over a critical part of their value offering- a Medical Device they previously purchased from an overseas manufacturer. The company would now be able to control supplies and tap into higher capacities for a cost advantage at volume.

“Emergnt Design Labs was excellent to work with!  Very competent, professional and responsive.  Sedation Systems was very pleased with the work they did for us… Would recommend them highly to anyone who asks!”

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The Miniscav shown assembled with Sedation Systems’ Vent Connector.

Jeremy Nashed

A product design expert, Jeremy cultivated his skills working in manufacturing and rapid prototyping facilities. His design experience ranges from consumer products to government contracting, and he is known for end-to-end support on every project.

M.S. in Mechanical Engineering, Georgia Institute of Technology.