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Design and Development

Trusted Co-creation Partners

Invetech specializes in supporting product development of clinical and life science instruments and consumables.  Our comprehensive and customizable product development services have successfully brought new products to the IVD, clinical, and life science markets for the past 35 years. 

>35

Years Experience

Customizable Fit

End-to-End Integrated Product Development Capability
Full Service Partner

Reduce risks and streamline development with single team supporting concept through production scale manufacturing.

Consultant Support

Augment team and fill gaps in expertise for specific development stages and/or sub-system components.

We can meet you anywhere along your journey.
PRODUCT PROPOSAL

Outline market opportunity and proposed product

Objective

  • To define a  product proposal that is expected to address the known market gaps

Program of work

  • Gather voice of customer (VoC) on current challenges and gaps to define goals for product concept
  • Asses interest from customers in target market in the product concept
  • Define target market and identify competitors
  • Evaluate estimated addressable, serviceable, and obtainable market opportunity size for product proposal

Key outcomes

  • A product concept with one or more design ideas to achieve key goals
  • A product proposal that has the potential to better meet market needs than currently available solutions

Problem and solution identified, user needs, market fit
PRODUCT FEASIBILITY

Lay the foundation for the development

Objective

  • To form a commercially viable project plan that is likely to meet the known market and product requirements

Program of work

  • Build familiarity with the chemistry workflow
  • Define critical product requirements
  • Develop concepts for consumable(s), core instrument subsystems (e.g. detector, consumable holder and pneumatics) and the overall system concept (component layout & industrial design) including preliminary user storyboard wireframes
  • Perform initial development risk assessment

Key outcomes

  • The product concept, CoGs, budget and schedule appear achievable and consistent
  • The product concept appears likely to meet the known requirements

Commercial viability, concept meeting known requirements
PRODUCT DEFINITION

Experimentally determine system concept performance

Objective

  • To define the product requirements and development feasibility

Program of work

  • Build test beds for consumable and instrument subsystems functions and evaluate key technical risks
  • Iterate and enhance concept designs as necessary
  • Perform system hazard analysis and concept FMECA
  • Define electronics and software architecture, and identify key OEM components
  • Perform initial usability assessment

Key outcomes

  • Proof of principle has been demonstrated for all primary, critical, and high-risk functions and technologies.
  • A viable technical solution can be described for all product functions
  • Product requirements have been defined
  • The project plan has been defined

Design inputs, architecture, design and project plan
CONCEPT DEVELOPMENT

Design and build integrated CDPs

Objective

  • To finalize the product concept and mitigate the technical and performance risks ready for detailed design

Program of work

  • Develop styling, component layout user interactions, and agree on concept
  • Combine consumable and instrument sub-systems into one integrated design
  • Assess integrated hardware operation and proof-of-principle performance
  • Commence evaluation of user interface styling and effectiveness with typical target users
  • Undertake review of failure modes (reliability and robustness) analysis, and perform preliminary review of regulatory compliance
  • Commence long term reliability testing of selected sub-systems

Key outcomes

  • Integrated performance of all critical functions (including consumables) has been demonstrated to agreed performance specifications on a CDP prototype
  • The product to be implemented is defined (e.g. Architecture, Design Description)

Concept prototype, critical requirements demonstrated
DETAILED DESIGN

Design, build and evaluate Alpha prototypes

Objective

  • Demonstrate the representative product design

Program of work

  • Generate the Alpha prototype design incorporating core features & functions
  • Conduct DFM manufacturability and serviceability reviews
  • Conduct FMECA review
  • Procure soft tooling for low risk parts
  • Generate verification test plans and procedures
  • Build, commission and qualify Alpha instrument and consumable prototypes, including preliminary EMC and UL assessment
  • Conduct usability assessment with Alpha prototype units (formative testing)

Key outcomes

  • Critical requirements demonstrated on an Alpha prototype.
  • Performance gap to address in Beta design revision defined

Demonstrate representative product design
DESIGN TRANSFER

Design and build fully featured Beta prototypes

Objective

  • Verify the production ready design and transfer the design to manufacturer

Program of work

  • Generate the Beta prototype design, incorporating remaining features & functions, and addressing issues identified in Alpha prototypes
  • Design and build Instrument assembly and test jigs & fixtures and PCP’s
  • Procure soft tooling for the remainder of parts
  • Build commission and qualify instrument and consumable Beta prototypes
  • Perform software and system design verification, including UL pre-compliance testing

Key outcomes

  • Design verified against requirements on a Beta prototype
  • Manufacturing process defined (to be validated by the manufacturing team during PPU build)
  • Design transferred into manufacture

Manufacturing process validated, verify production design
SUSTAINMENT SUPPORT

Establish instrument manufacturing capability

Objective

  • Instrument and consumables are ready for commercial production

Program of work

  • Fix any design non-conformances arising from verification testing
  • Finalize instrument manufacturing Supply Agreement
  • Prepare RoHS technical file, and finalize Design History File
  • Conduct CE and UL compliance testing
  • Establish supply chain for instrument production
  • Build instrument Pilot Production Units

Key outcomes

  • Manufacturing team has confirmed readiness to commence manufacturing
  • PPUs built
  • Manufacturing process Validated
  • Manufacturing team able to confidently build instruments without further design team involvement

Production manufacturing, routine improvements and upgrades

Agile Device Design

In the highly dynamic diagnostics industry, it’s critical to incorporate best-in-class development principles to ensure success. Invetech has learned many lessons through our experience in bringing to fruition dozens of FDA/CE-approved medical devices. Our agile approach to designing diagnostic devices enables fast time-to-market and optimal product-market-fit while developing robust instruments for scalable manufacturing.

User Experience Design

Invetech’s design and development teams routinely incorporate user-centered design strategy into projects. Innovation Labs offers experience user design services to bring innovation and human-centered design approach to help your development teams anywhere along their journey.

INNOVATION LABS

Let’s make something great!

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