CASE STUDIES

COVID-19 Point of Care Diagnostic Test Platform

Invetech rapidly delivered a COVID-19 Point of Care molecular diagnostic test platform ready for large-volume production in a matter of months, using an MVP strategy to optimize time-to-market

Client: Life science startup focused on rapid, point-of-need solutions

Product: Rapid Point of Care (POC) molecular diagnostic platform designed for CLIA Waiver

Expertise Used

Systems Engineering, Consumable Development, Supply Chain Management, Optics, Design for Manufacture, Usability/Human Factors and Experience Design, Accelerated Development, Ultra-Rapid Iteration, FDA Emergency Use Authorization

Rapidly responding to the critical need for COVID-19 testing

In response to the SARS-CoV-2 virus and demand for diagnostic testing, the United States Food and Drug Administration (FDA) called for accelerated development of COVID-19 healthcare solutions and expanded national testing capacity. Under the FDA emergency use authorization (EUA) directive, our client set out to develop a rapid, molecular diagnostic test for the identification of the SARS-CoV-2 virus that was able to be run by non-medical personnel.

After receiving funding from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative, they engaged Invetech to rapidly convert a manually performed chemistry to an automated consumable-plus-instrument platform that could be used in Clinical Laboratory Improvement Amendments (CLIA)-Waived settings.

The objective was to get to market as rapidly as possible with a fully functioning platform to help address the critical need for diagnostic testing. As part of the product development strategy, design optimization was intentionally deferred to accelerate the delivery on a Minimum Viable Product (MVP).

In under six months, we needed to:

  • Establish the platform architecture and define product requirements through transfer to manufacturing
  • Address key technical risks associated with integrating an existing mature sample prep protocol and consumable into an integrated POC cartridge
  • Arrive at a Minimum Viable Product (MVP) device that met core requirements and was both simple to use and able to scale in production
  • Build an instrument that could be scaled effectively to be manufactured in large volumes, shipping at a rate of thousands per month

“There is an amazing thing that happens when people work together toward a shared vision that has such a significant impact on society. Throughout this expedited product development process, we saw a profound shift in people’s perspective on what is possible.”

Gerald Kent

VP at Invetech

Creating a project management structure to match the development speed

When decisions typically made over the course of weeks or months needed to be made in days, we recognized a different approach was required. Specifically, we needed a project management structure that was extremely agile, provided a higher level of oversight, and involved touchpoints on a more regular basis.

Keeping the team focused on the highest value activities called for an active leadership group and a designated product owner, or ‘chief engineer, capable of making practical decisions on where to direct collective energy.

In addition to the chief engineer as an overall point person, key team members were assigned full architectural oversight to maintain a systems-level view of the entire project.

The project ran as a series of three-week sprints. During each sprint cycle, we had leadership and executive meetings with the client daily (as opposed to weekly) and team working groups were reporting out three times a day (instead of typical daily stand-up meetings). At the end of each sprint cycle, a steering committee met to review the project status and make strategic decisions.

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Driving to a Minimum Viable Product

In balancing overall development with costs and complexity, the program goal was to get to market with an MVP as quickly as possible; design optimization could be addressed through post-launch improvement programs.

Having a chief engineer and an architectural oversight group in place was crucial in establishing the baseline product profile as well as outlining and managing both the project strategy and implementation.

Ongoing communication helped ensure broad stakeholder alignment with an MVP concept. Continued reinforcement of that overall project direction kept team members tracking to the timelines around critical path items while driving to an MVP instead of a “perfect” design.

Under MVP principles, it was faster to design for the more straightforward workflow steps using a larger number of parts, each doing one function (rather than develop one elegant part to complete all those same functions). While taking this path created greater product complexity, it allowed us to focus time and effort on solving problems where investigation and innovation were required.

We were also able to leverage multiple time zones to accelerate experimentation and innovation. For example, the team in San Diego would run experiments and provide those inputs to team members in Melbourne the following morning to execute changes.

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Establishing an accelerated, parallel development approach

To deliver an MVP within the aggressive project timeframe, we needed to identify risks up front and simultaneously test alternative solutions. We designed a testbed that could utilize interchangeable components and worked under the assumption that at least one of the components would work. This high-speed, parallel experimentation supported quickly making significant architectural decisions, allowing both creative problem solving and risk mitigation in the process.

To get the testbeds up and running quickly, we leveraged proven technologies and modules from past projects. This included an electronics architecture to drive various subsystems and move detection sensing equipment, a software platform to easily run the electronics, and a PCR-based fluorometric system that we matured and customized to fit the workflow.

“The fluorometer and the heating had to be absolutely rock solid for the PCR system to operate. Having modules for these core system components as a starting point really gave us a leg-up in the design. It meant that we could quickly test out the core systems and have more confidence in them.” – Lauren O’Connor, Program Manager at Invetech

Using these “building blocks” as a starting point helped us to quickly test and prototype things, while also being able to modify the configuration quickly and easily, as needed.

Involving supply chain from the start

With the industry-wide push to rapidly develop COVID-19 solutions and the high-speed scramble for medical device components, it was imperative to secure items that could be in a back-order situation. A specific project team was established to focus on setting up the supply chain and building out inventories, concentrating on at-risk areas that could impinge on the project’s ability to move forward.

Waiting until the product design was mature to finalize supply agreements with vendors was not an option. To help build confidence in both the design direction and supply commitments early on, an Invetech manufacturing engineer was assigned to the product development technical team. They completed a first pass manufacturability evaluation so we could begin getting feedback and additional inputs from supply partners. By mitigating risks associated with their resource investments, we were able to work under “in principle” agreements with vendors during development phases.

Our ability to leverage the extensive global supply chain capabilities and network of Fortive, Invetech’s parent company, was another crucial aspect in being able to source items at the speed required for the project. Supply chain management was directly imbedded into the overall program strategy and structure, with a Fortive representative assigned to be a member of the manufacturing sub-team. This facilitated our ability to tap into a Fortune 500 company’s buying power and established procurement capabilities. It also allowed for seamless oversight of the full scope of supply chain activities – from aligning vendors and ensuring finance arrangements were in place to managing contracts and maintaining quality system compliance.

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Delivering an MVP test platform in record time

This project is an example of how to successfully manage full-throttle product development to deliver an MVP that meets aggressive timelines without compromising quality.

Invetech successfully delivered a COVID-19 POC molecular test platform ready for large-volume production in a matter of months, drastically compressing the typical three-year development and scale-up timeframe. The result was a user-centric MVP design fully meeting all platform performance requirements.

The speed of the project delivery enabled the client to greatly expedite the launch of the test, and rapidly scale manufacturing to help address the urgent need to expand COVID-19 testing capacity globally.

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