Diagnostic Device Design and Manufacturing – The Engineer’s Perspective

Since 2004 Symbient has been at the forefront of diagnostic cartridge development resulting in over 300 disposable cartridges. As a product development firm, we specialize in plastic, disposable devices. Our success in this field is due to our expertise in highly complex “meso-scale” and microfluidic cartridges, production-quality prototype molding capabilities, and our pilot production offerings for clinical studies. Clients receive end-to-end product development services.

Our extensive experience in cartridge engineering has given us a deep understanding of microfluidics, small volumes, and fluid dynamics.  These projects entail fluid handling requirements in small volumes, ranging from milliliters (ml) to microliters (µl). We bring assay protocols to life developing a variety of features to execute plasma separation, Polymerase Chain Reaction (PCR), RNA and DNA purification, cell lysis, bacterial analysis, biomarker expression, and more. Our team can quickly achieve these fluidic requirements through:

  • Static and active mixing, aspiration, filtration
  • Normally closed and normally open valve designs that are low cost / consumable
  • Metering/aliquoting, precise sample splitting; including array distribution
  • Capillary action, surface tension, adhesion, wetting

Throughout the development process, our team creates prototypes that are optimized for manufacturing, using manufacturing-grade equipment. In addition to our rapid prototyping SLA and Polyjet printers, we can rapidly prototype injection molded parts. This capability allows us to iterate quickly, using commercial-ready materials, which is essential when developing assay-based cartridges whose materials could impact the chemistry and detectability. The rapid injection molding is done in Symbient’s full machine shop, which includes:

  • 4 Haas CNC mills
  • 1 DMG MORI CNC mill for higher tolerances
  • 2 lathes
  • 4 Arburg molding machines

In addition, we offer over-molding and silicone molding capabilities, and we carry a full stock of core cartridge materials, including our most used polycarbonate, polypropylene, and polyphenylene. While typical contract manufacturers would take 8-12 weeks to create a mold, Symbient can do so within a week and perform any mold modifications within a day. The quick-turn molding process is a key differentiator that sets Symbient apart from others.

To round out our end-to-end services, we offer pilot production, which buys customers the time to contract with a high-volume manufacturer. The time to market for a contract manufacturer is typically six months. During this time, Symbient can produce 100’s to 1000’s of assemblies per month utilizing our in-house equipment such as:

  • laser welding
  • ultrasonic welding
  • heat sealing
  • die and laser cutting
  • vacuum forming

We also have inspection equipment such as leak testers, a force tester, and a Keyence vision system. By engineering and manufacturing products in the same place, we have “accountability in design.” That means our design engineers stay with their designs into manufacturing and quality control testing to refine the design for manufacturing and assembly. By designing for manufacturing in-house, Symbient saves time and money by addressing issues prior to high volume manufacturing. The cost of changing a production tool vs. a prototype tool can have a significant impact on a client’s budget.

The phrase “time is money” reflects the mantra of our clients. Symbient proudly fast-tracks the research, design, and development phase by using our team of experts and state-of-the-art equipment, saving the client time and money. By choosing Symbient, clients are on the quickest path to a quality product. Our emphasis on quality and excellence has resulted in our extensive product portfolio, including:

  • 247+ Cartridges (instrument or non-instrument driven)
    • Molecular, Amino, Immunoassays, etc
  • 121+ Sample Collection & Processing
    • Blood, Stool, Saliva, Urine, Swabs, etc.

Contact us today to develop your next medical device prototype.