Are you responsible for fast-tracking Class III device development? Designing microfluidic instruments? Incorporating more sensors in a smaller package? We can help you with that, and more. We’ll meet your requirements for the use of FDA-approved Class III materials and manufacturing processes. Provide documentation packages that include material traceability (incoming inspection and documentation), along with part/substrate serialization. No matter whether you need to assemble a few beta units, low volumes of less than 100 units a year, or are ready to scale to high volumes, we have the engineering experience and specialized equipment to get it done.

Automating custom processes for unique medical devices is our specialty

Many medical products require the use of organic materials such as adhesives to join parts, encapsulants to seal parts, coatings to prevent contact and to provide isolation. These organics are deposited in a variety of manual or automated dispensing methods requiring precision and control that only a highly experienced technician can provide.

Unique devices also often have equally unique production requirements such as not exceeding 85° C during assembly, or handling die that cannot be exposed to cleaning processes. Fluid processing devices in particular require excellent adhesion between surfaces and elimination of voids or bubbles in organics. No matter how unique your requirements, we can specify the best materials, cleaning processes and surface preparation to avoid leakage and ensure stable performance.

You make it up. We’ll make it happen.

  • Implantable Devices driven by size and compatibility with the human body and surgical practices with reliability requirements well beyond standard
  • Instruments, cameras, diagnostic equipment utilizing imaging, energy delivery, and sensors integrated into extremely compact packages
  • Image sensors requiring manufacturing processes that eliminate particle contamination, i.e., processing in low-particulate environments, storage of work-in-process in controlled environments and careful packaging of finished products
  • Diagnostic Devices for detection and analysis of samples using a mix of small-format optical, thermal, or electrical detection mechanisms; many are primarily fluidic assemblies requiring fluid sealing, electrical isolation, cleanliness, particle control, optical transparency and long-term stability
  • Disposable Diagnostic Devices used for a single run of a medical or biologic sample to detect DNA, bacteria, blood chemistry, lactose, blood sugar, etc. that combine wet sample handling with electronics and sensors
  • Personal Health Devices/Wearables requiring low-volume mixed assembly, tolerance for extreme temperatures, water immersion, organic contamination, ruggedized design and a small form factor.

Process Capabilities

  • Custom optical path design and diagnostic chips requiring special processing
  • Integration of optics with bare die
  • Sterilization, plasma cleaning, wet bench cleaning and cleaning using water-soluble fluxes to minimize residue
  • Encapsulation
  • Leak, electrical and optical testing, ionographic verification, data collection
  • Engineering of dispense pattern to minimize voids and control fillets
  • CSAM and X-ray to verify results
  • Microfluidics with either molded or etched forms
  • Controlled, high accuracy dispensing of medical and biocompatible organics for sealing and fluid flow control (adhesives, sealants, die attach materials and encapsulants)
  • Wire bonding
  • Process flex or folding circuitry
  • Mechanical Nexiv measurements (automated, dimensional X, Y Z and theta measurements to +/- 1 micron and +/- 0.1 degree accuracy, automated file generation)
  • Packaging for shipment, including sealing in final container in cleanroom environment

Heterogenous Assembly

  • Conventional SMT, direct chip attach with flip chip and COB on a variety of substrates including FR-4, FR-5, thick- and thin-film ceramic, flex and rigid circuitry
  • Optical assembly
  • Integration of wide variety of sensors into small assemblies
  • Adhesive assembly requiring sealing to control fluid flow combined with electronics in a SIP
  • Assemble and seal interfaces for mechanical elements with various adhesive dispense methods, optical elements with thermally cured and UV adhesives, parts molded in polymers, machined parts and fluid control channels
  • Assembly in Class 100 and Class 1000 cleanrooms
  • Assembly and integration of parts made in separate processes
  • Precision placement with +/- 6 micron accuracy of complex stacked assemblies
  • Pick die and other components from waffle pack and wafer as sawn on tape
  • Die attach using a variety materials and methods including dispensed and stamped epoxy (both conductive and non-conductive) and die attach film (DAF)
  • Die adhesive fillet and void control using DAF