Our History – Designing Diagnostic Devices

There are many reasons to use an engineering design company to design your diagnostic product.  If you are a small or start-up company, you might need to fully outsource engineering to bring you all the way from design to launching into manufacturing.  If you are a large company with engineers on staff, they might already be committed to projects underway.  Working with an outside firm can fill that gap and also adds the benefit of focused experience.

Deep Experience in Diagnostic Design

We have been designing, molding and assembling diagnostic cartridges and collection devices since Symbient opened in 2004.  Our founder, Scott Castanon, a Biomedical Engineering graduate from UCSD, worked at local biotech companies before taking the leap to start Symbient.  Some of our long-term clients, like Quidel and BD, have been through several product iterations of their life cycle with us.  We are now up to 13 full-time engineers and have completed over 368 diagnostic projects!

Figure 1: Instrument-Driven Electrochemical Biosensor Diagnostic with Sample Prep

We Have Seen Some Things

One of the benefits of being in this business for so many years is the opportunity to work on many different projects.  We have a design library of valves, fasteners and fluidic concepts that can be drawn on to optimize your project.  No other firm has designed and created more molds in-house than Symbient – over 1,300 molds just for our diagnostic clients.  And with our versatile assembly area we can create an assembly that includes laser welding, ultrasonic welding or heat sealing in a clean room if needed.

 

Figure 2: Integrated blood collection, plasma separation and test cartridge

So Many Sample Types

We have designed sample collection or processing devices for all relevant human diagnostic samples and even some for insects, plants and food products.  Many are integrated into a cartridge to provide a sample-to-answer solution.  Blood collection from 10 ul to >100 ul, nasal swabs with sample processing, and urine cups with integrated assays are just a few of the unique systems we have designed and molded.

Instruments Too!

Over 50 of our cassette designs were designed to interface with an instrument.  In each project there is a balance between cost of the consumable and complexity of the instrument.   For some assays, an instrument interface can increase sensitivity of the assay by using advanced detection methods.  Some assays, like PCR, rely on an instrument for heating, cooling and valve operation.  We can help you fine-tune this balance for your project.

Designed for Quality

We have been ISO 13485 certified since 2011 and recently upgraded to the 2016 standards.  Our quality system provides a structure for creating a consistent customer experience.  Many of our designs have been granted CLIA-waved status – we know how to design to meet these criteria.

Tell us about your project today!