Molecular Diagnostics Devices

Beyond the myriad technical challenges to be solved when creating any new product, designing novel diagnostic instruments requires a unique blend of systems design expertise and biochemical process understanding. Simplexity helps clients navigate this complex development landscape through close collaboration with the core biotech team, establishing a well-defined interface and setting the common objective of designing a successful instrument. 

If the product to be designed is a medical device, additional risk reduction and design control activities through the product development cycle are required, and we work closely with clients to ensure that all regulatory requirements are met. We have experience working in a quality management system to ensure all product requirements and user needs are met. 

CHALLENGES OF BIOTECH SYSTEMS DEVELOPMENT  

Biotech instruments are becoming more broadly used and widely adopted, and the incentives for developing lower-cost systems have increased. Simplexity’s expertise in product architecture, mechatronics, and high-volume manufacturing has led to a growing number of successful partnerships within the biotech industry. Common challenges that bring clients to Simplexity are: 

• Ground-up, full system development 
• Technology feasibility evaluation or isolated technical hurdle resolution 
• Proof-of-concept devices for technology demonstration 
• Design of a cost-reduced and design-optimized next-generation product 
• Translation of a low-volume design to a high-volume, production-ready design 
• Product architecture expertise 
• Quick-turn testbeds and test software for assay and cartridge development 
• Production test and characterization tools to aid production or product development 
• Comprehensive program planning, phase-gate build objectives, risk assessment, development budget, product cost estimation 
• Manufacturing strategy (contract manufacturing selection, tooling strategy, test planning, quality management) 

SIMPLEXITY'S CAPABILITIES AND EXPERTISE  

As an engineering and technology-focused design company, our goal is to assemble the best design team in the industry around our core competencies of product design and Molecular Diagnostics. These include: 

• Design for reliability, testability, usability, and manufacturability 
• User experience design and workflow analysis 
• Liquid handling and pump systems 
• Sensor development 
• Motors, actuators, and control 
• Integrated sensors and electronics 
• Displays 
• Disposable and rechargeable battery systems 
• Test and assembly automations 
• Precision temperature control 
• Designing to medical device standards as required 

Our product engineers and project managers have worked with biotech clients to design products and systems in the product categories of: 

• Library preparation instruments 
• IVD sample prep instruments 
• Cell therapy manufacturing tools 
• Liquid handling systems 
• Point-of-care diagnostics instruments 
• High-precision, low-volume fluidic systems 
• Opto-mechanical systems 
• Thermo-control systems 
• Complete motion subsystems

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. 

Molecular Diagnostic Capabilities Overview:

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