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Guide: Best Practices for Point of Care Product Development

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When developing cartridges for Point of Care (POC) instruments, it is easy to focus on early design issues and neglect future needs, such as scaling up production for prototyping, clinical trials, and, ultimately, full-scale marketing.

This can be particularly true for startup companies, which are often focused on proving feasibility. Larger companies can face different issues such as leveraging their existing production resources without considering  the types of modifications they must make to the manufacturing process to support the new product.

Going from prototype to production, scale-up is a critical step that typically can take  18 months to complete. This timeline, and the many associated costs, should be thoroughly integrated into the planning process from the start. You have to address consumable molds, production automation, packaging equipment, and other specialized resources. Robust planning, throughout the development process, will help ensure the product gets to market – in sufficient quantities – in a timely manner.

The value of comprehensive planning

Early planning is critical to ensure a successful scale-up, but it is important to incorporate flexibility into these plans. Demand can often be a moving target, and production may have to adjust as forecasts change. Make a plan, but be ready to react.

Production planning should be integrated into early design phases. There are many factors to consider, such as capital investments and the overall timing. In addition, manufacturing, like design, is an iterative process. Initial yields may be lower than anticipated and will need to be ramped up. While planning, factor in non-production activities, such as set-up and line clearance, which can reduce yields.

Many inputs go into estimating manufacturing capacity. Most calculations assume 7-hour shifts, with time for lunch and other breaks. Provisions for yield will also improve the quality of your estimate. Using a typical manufacturing model that estimates a 3-second cycle time, with a 7-hour shift and an 85 percent yield provides a good starting point for your model. But, consider making adjustments based on your product and maturity of the manufacturing line.

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When calculating capacity, factor in workflow setup before production. This may include line clearance time to reduce cross-contamination risks, system cleaning, and independently verifying each batch. Workflow setup may also include off-line activities, including reagent preparation and quality control (QC) and complete release acceptance testing.

It is also important to determine early on which components and processes will be manufactured and conducted in-house, and which ones will be contracted to third parties. If third-party support is necessary, you need to plan for additional time to form those partnerships.

The appropriate vendor(s) must be selected by striking the right balance between capabilities, cost, quality, proximity and any other product-specific factors. Adequate time allowances need to be included to qualify suppliers and negotiate appropriate supply agreements.

Early in development, when volumes are much lower, manually dispensing small reagent batches into cartridges can meet demand. However, as batch sizes ramp up for validation testing and clinical trials, you must move to a high-volume process.

To get there, you must:

  • Automate and scale-up low volume lines
  • Replicate production lines to account for down-time redundancy and higher volume needs
  • Build in development and engineering support
  • Develop modular production line sections to rapidly scale around bottlenecks

Implement a representative production process

Invetech-poct-cartridgeOne key task – early in system design – is developing a representative production process that demonstrates how you will consistently produce high-quality cartridges at projected volumes.

To create this, you will need people who have hands-on experience throughout the manufacturing process. Input from designers, engineers, and production staff will inform cartridge design throughout the development cycle. It will also confirm that the manufacturing process will meet design requirements and provide acceptable yields.

There are several important steps to consider:

  • Identify the processes that are most important to product quality. Ultrasonic welding, reagent deposition, drying and sealing, and other processes can have major impacts on the microfluidic cartridge’s quality and performance. For example, if a welding process creates a problem area, that imperfection can impact production-stage cartridge performance.
  • Ensure that early work to develop the production workflow – selecting technologies, prototyping automation methods, etc. – includes volume automation components, such as welding horns and reagent deposition pumps, valves, and dispense heads.
  • Develop methods to assure quality and monitoring consistency. Use non-destructive verification, such as visual confirmation, pressure monitoring, and positive displacement feedback.
  • Assess process capabilities against requirements to understand margins under normal conditions. This can simplify automated process validation.
  • Understand assay and design sensitivities. For example, the process may deposit five reagents, with one being volume sensitive.

Start with a low-volume line

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Given market uncertainties, it can make sense to create a low-volume pilot consumable manufacturing line for the initial launch. Later, as demand increases, you can ramp up to a high-volume line.

This approach can bring greater flexibility to manufacturing. Pilot lines are simpler to modify, making it easier to refine the consumable, as necessary, before entering high-volume production.

Specifically, low-volume lines are excellent tools for continued product iteration and optimization. You will need sufficient numbers of prototypes to test them, refine assays, and conduct clinical trials.

Pilot lines help companies control cash flow while waiting to determine a product’s market strength. Still, planning the transition from low- to high-volume lines must be airtight. Companies that are surprised by process changes during this transition are likely to experience delays and higher than expected product costs.

  • Make sure the high-volume line is being developed in parallel to eliminate production delays that could hinder market adoption.
  • Understand how the manufacturing process may change between the pilot and high-volume lines. While the pilot line can tolerate manual process, these will need to be automated when volumes ramp up. Understanding this transition can reduce re-validation efforts for the high-volume line and may eliminate the need for additional clinical trials.
  • Incorporate automated QC into the high-volume line. Again, manual QC will work for the pilot line, but this approach may not be sustainable as volumes increase.

Production scale-up planning drives long-term profitability

Integrating production scale-up planning and automation throughout the design process supports seamless transfer to manufacturing and successful market launch, building confidence in both the product and the manufacturing process. In addition, formulating a solid plan will help you respond to demand during the product’s all-important initial rollout. Ultimately, this rigorous planning ensures there are few manufacturing delays, and production meets demand.

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