Biotech Product Development

Are you designing a next-generation biotech instrument?

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 you navigate this complex development landscape through close collaboration with your core biotech team, establishing a well-defined interface and setting the common objective of designing a successful instrument.

If your product will be classified as a medical device, additional risk reduction and design control activities through the product development cycle are required. We can work closely with you to help ensure that all regulatory requirements are met. We have experience working in our ISO-13485 certified Quality Management System (QMS) or are happy to work in your QMS if your company already has one in place.

Do you need Biotech Product Development to:

• Shorten R&D cycles
• Get back to innovating
• Shorten time-to-market
• Get relief for internal, overtasked design teams
• Fill an immediate need for expert product design engineers
• Define manufacturing requirements earlier in your development process
• Improve your design for manufacturing success rate
• Minimize New Product Introduction CM hand-off risks

Simplexity can help you address all these challenges and create a product plan that is both cost-efficient and manages risk, prioritizing the specific needs of your project.

Simplexity’s Biotech Product Development capabilities and expertise

As an engineering and technology-focused design company, our goal is to help you assemble the best design team in the industry. In addition to the skills on your team, Simplexity can help you with:

• 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

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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)

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

• Library preparation instrument
• 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.

Leading biotech firms have selected Simplexity to help design their instruments and products. Learn more about how we can help you turn your ideas and promising prototypes into market-ready products while reducing your costs, saving you time, and simplifying your design!