MOLECULAR DIAGNOSTIC INSTRUMENTS CAPABILITIES
Designing novel molecular diagnostic instruments requires a unique blend of systems design expertise and biological process understanding.
Simplexity’s experience in molecular diagnostics instrument design and close collaboration with assay and consumable teams, brings unique expertise to expanding applications in this vital and evolving market. Our ISO 13485:2016 certified quality management system ensures rigorous development of devices that are safe for their intended use.
Common Challenges and Needs That Bring Biotech Clients to Simplexity:
- Product architecture expertise for new instrument platforms
- Technology feasibility evaluation or isolated technical hurdle resolution
- Proof-of-concept devices for technology demonstration
- Comprehensive program planning, phase-gate product development process, risk assessment, development budget,
product cost estimation - Cost reduction and design optimization for next-generation products
- Automated workflow testbeds for assay and cartridge development
- Production test tools for monitoring critical performance metrics
- Characterization tools to execute design of experiments during instrument development
- New Product Introduction (NPI): build planning and coordination, contract manufacturing selection, tool strategy, test planning, quality engineering and design for manufacturability
- Designing to medical device standards as required
Simplexity Biotech Expertise
- Instrument architecture and development strategies
- Laboratory instrument product development
- Cartridge-to-instrument interfaces optimization
- System integration and testbed delivery
- Production and characterization test tools
- ISO 13485:2016 certification for medical product design and development
- NSF-audited certified Quality Management System
- New Product Introduction (NPI)
- Design for Manufacturing (DfM) and Design for Assembly (DfA)
- Value engineering
- Robotic systems
- Wireless connectivity
Supported Product Categories:
Simplexity’s large, fast-ramp team of expert product engineers and project managers have worked with biotech clients to design products and systems in the following categories:
- Liquid handling instruments
- Point-of-care diagnostics instruments
- PCR instruments
- Library preparation instruments
- Sample preparation instruments
- Cell therapy manufacturing tools
Product Development Competencies:
As an engineering and technology-focused design company, we have assembled the best design team in the industry around core competencies of product development and molecular diagnostics. These include:
Subsystem Development
- Complete motion subsystems: gantries, robotic arms, actuators, cartridge loaders
- Thermal systems: thermocycling, precision temperature control
- Fluidic systems: pumps, valves, manifolds, tubing
- Optical and opto-mechanical systems: machine vision, alignment and inspection, barcode readers
- Magnetic design: solenoids, alternators, motor
Cartridge Interfaces
- Pneumatic
- Sonication
- Magnetic
- Valve actuation
- Thermocyclng
- Opto-mechanical
Process and Test Development
- Characterization testbeds
- Workflow analysis and automation
- Characterization DOE and test
- Design analysis
- Production process analysis
- Tolerance analysis
Communications
- Ethernet
- Bluetooth Low Energy (BLE)
- Bluetooth
- WiFi
- Cellular
- RFID/Near Field Communication (NFC)
- Thread, Zigbee
- ISM bands with custom protocol
Why Simplexity?
Biotech instrument leaders choose Simplexity Product Development to accelerate and de-risk their product development. Since 2005, we have been a trusted partner in product commercialization, with a depth of expertise in product architecture, mechatronics, and complete system design for cost-effective manufacturing. Simplexity engineers hold over 200 patents collectively.
Simplexity has a deep understanding of the molecular diagnostics development space and the unique requirements that must be met to achieve success. We look forward to partnering with your company’s core technology experts, working shoulder-to-shoulder to enable the rapid transformation of novel concepts into real, safe products.
Contact us to learn more about our molecular diagnostics development capabilities. Simplexity understands the challenges of designing Molecular Diagnostics and we speak your language. Working shoulder-to-shoulder with you, we are focused on transforming your novel idea or benchtop proof-of-concept prototype into well-designed integrated instrument ready for the marketplace.
Software: Design Complete
Hardware: Pre-production units for design verification
MFG. Readiness: CM schedule and budget, Unit build tracking