Product / Instrument Design + Development

Building on our 30-year history successfully bringing new products to the clinical and IVD market, Invetech continues to hone our product development service to deliver the right solutions for diagnostics and biomedical companies worldwide. Our human-centered approach to design, agile product development processes and full-spectrum of product realization services deliver outstanding products that meet the most challenging clinical and business needs.

A proven pathway to success

Problem definition
Concept creation
Design + Engineering
Establishing manufacturing
Production ramp-up

Problem definition

Successful products must solve both real business needs and real user problems to deliver value to our clients and their customers.

Before the start of a project, we work closely with clients to fully understand their business needs and goals. With those upfront insights plus our deep understanding of the IVD market, we initiate the process of discovering the needs and goals of users.

To identify and understand the problems a product must address for the user, our experience design and engineering teams immerse themselves with 

the people, challenges and user environment to discover the user’s true goals and pain points at the start of the product development process. 

This front-end design research involves observing users in context to develop a view of their end-to-end workflow with a product or system at the point of use, including digital, physical and human interactions. These research insights are then analyzed and synthesized into actionable findings and clear objectives that serve as a guide throughout the development process.

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Concept creation

Through our rigorous systems engineering and solution architecting processes, we take the problems identified and create product solutions that are customized to deliver on all stakeholders’ needs.

We explore candidate solutions by building, evaluating and testing multiple product concepts at the user and subsystem level using a “design, build, test, iterate” approach. As we move from lower to higher fidelity prototypes, we work to deliver on user needs, usability, and IVD manufacturer requirements such as performance, manufacturability, cost and risk. We take early concepts into the field and test them with real users.

This allows us to quickly check key assumptions and identify improvements by observing what works well and where friction or risks exist in the interactions. Through multiple iterations, features and functionality can be prioritized or improved to ensure that the needs of both users and the manufacturer are being met.

By the end of this phase, a product concept and architecture are established with a high degree of confidence that they will deliver both market value and technical feasibility.

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Design + Engineering

Based on concept testing and review, we create the detailed product design and build representative Alpha prototypes. Our focus is to confirm that all product functionality and requirements are fully addressed, including all key performance metrics, product safety, reliability, cost and manufacturability. At this stage, we also prove fully featured software and firmware.

We continue to learn from and refine the product designs as the prototypes move through usability testing and field evaluation trials, identifying any performance or reliability issues and assessing any risk associated with normal use of the device, maturing the design to product ready Beta maturity.

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Establishing manufacturing

Beta prototypes are built using fully representative manufacturing and assembly methods, proving both the design suitability and the production processes. These are full functionality production representative units, including all physical and digital user interface features of the final design. These Beta prototypes are the basis for our formal Verification of the design and Validation in real use environments by our clients.

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Production ramp-up

Even after formal transfer of the design to our (or your) manufacturing facility, we continue to provide support during manufacturing process Validation and scale-up. We also provide troubleshooting support of manufacturing, assembly and testing. Depending on client needs, partnering on contract manufacturing provides a seamless internal transition for the final product.

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Problem definition

Successful products must solve both real business needs and real user problems to deliver value to our clients and their customers.

Before the start of a project, we work closely with clients to fully understand their business needs and goals. With those upfront insights plus our deep understanding of the IVD market, we initiate the process of discovering the needs and goals of users.

To identify and understand the problems a product must address for the user, our experience design and engineering teams immerse themselves with 

the people, challenges and user environment to discover the user’s true goals and pain points at the start of the product development process. 

This front-end design research involves observing users in context to develop a view of their end-to-end workflow with a product or system at the point of use, including digital, physical and human interactions. These research insights are then analyzed and synthesized into actionable findings and clear objectives that serve as a guide throughout the development process.

img

Concept creation

Through our rigorous systems engineering and solution architecting processes, we take the problems identified and create product solutions that are customized to deliver on all stakeholders’ needs.

We explore candidate solutions by building, evaluating and testing multiple product concepts at the user and subsystem level using a “design, build, test, iterate” approach. As we move from lower to higher fidelity prototypes, we work to deliver on user needs, usability, and IVD manufacturer requirements such as performance, manufacturability, cost and risk. We take early concepts into the field and test them with real users.

This allows us to quickly check key assumptions and identify improvements by observing what works well and where friction or risks exist in the interactions. Through multiple iterations, features and functionality can be prioritized or improved to ensure that the needs of both users and the manufacturer are being met.

By the end of this phase, a product concept and architecture are established with a high degree of confidence that they will deliver both market value and technical feasibility.

img

Design + Engineering

Based on concept testing and review, we create the detailed product design and build representative Alpha prototypes. Our focus is to confirm that all product functionality and requirements are fully addressed, including all key performance metrics, product safety, reliability, cost and manufacturability. At this stage, we also prove fully featured software and firmware.

We continue to learn from and refine the product designs as the prototypes move through usability testing and field evaluation trials, identifying any performance or reliability issues and assessing any risk associated with normal use of the device, maturing the design to product ready Beta maturity.

img

Establishing manufacturing

Beta prototypes are built using fully representative manufacturing and assembly methods, proving both the design suitability and the production processes. These are full functionality production representative units, including all physical and digital user interface features of the final design. These Beta prototypes are the basis for our formal Verification of the design and Validation in real use environments by our clients.

img

Production ramp-up

Even after formal transfer of the design to our (or your) manufacturing facility, we continue to provide support during manufacturing process Validation and scale-up. We also provide troubleshooting support of manufacturing, assembly and testing. Depending on client needs, partnering on contract manufacturing provides a seamless internal transition for the final product.

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Why Invetech?

We know what it takes to address the top challenges facing IVD manufacturers, including the need for innovation, time to market pressure and delivering quality at an acceptable cost.

Diagnostics & Life Sciences Clients

Over the last 30 years we have partnered with diagnostics and life sciences companies across the globe to deliver market success.

Case Studies

Below are a selection of case studies highlighting the range of problems we’ve solved to deliver innovation and business value for our clients.

Also Check Out

Below is a selection of our most recent diagnostics articles, resources and insights.

Let’s make something great

Our scientists, engineers, designers and program managers know what it takes to make your diagnostics project a success.