point of care diagnostics instrument design

Guide: Best Practices for Point of Care Product Development


Early in the Point of Care (POC) diagnostic product development process, it’s important to be agile and iterate quickly. However, as you get closer to manufacturing, the design needs to be locked down, parts need to be sourced and lead times need to be considered.

If you wait until the device design is fully matured before bringing in the manufacturing supply chain, you lose the opportunity to change parts to lower cost options. Furthermore, changes must be re-verified which will impact time to market.

By embracing a process that integrates both the design and manufacturing teams early on, potential problems can be anticipated, and either eliminated or mitigated through design, quality vendor selection, and other means. This can mean lower material and labor costs, faster production and fewer delays. It can also translate into better quality, fewer warranty issues and, ultimately, a stronger reputation.

Below we have outlined 5 ways design and manufacturing teams can work together throughout the product development process to design lower cost POC diagnostic devices, including:

    1. Planning for manufacturing from the start
    2. Preparing for production with 3P
    3. Designing for assembly and manufacturability
    4. Sourcing parts and establishing the supply chain early
    5. Refining the process to improve quality and repeatability

1. Planning for manufacturing from the start

Manufacturing planning needs to start with a high-level understanding of the process from how a design will be transferred to production to the way it will be manufactured. If this step is not completed early, it causes costly changes and re-work at later stages.

From a quality perspective, any inputs from manufacturing planning that can be integrated into the design from the start will generate a better product with lower production costs.

Examples of planning inputs include:
– Fastening, alignment and test strategy
– Available equipment, skills and restrictions
– Supply chain logistics
– Regulatory requirements and certifications

The best way to give the design team this input is by establishing an integrated design and manufacturing team to develop manufacturing requirements before the design matures.

Knowing who will manufacture the product is also an important step. The manufacturer will have existing processes and requirements that need to be considered to plan the most cost-effective way to manufacture the product.

2. Preparing for production with 3P

Before completing detailed designs, it’s important to perform a rigorous assessment of the product concept to fully understand the core technology and estimate all costs. These analyses will inform the design and can have a powerful impact on manufacturing costs.

A tool we use to streamline this process is 3P, the Production Preparation Process. This tool breaks the process down to basic fundamentals to reset thinking and build an efficient and considered approach for production.

For new product development, we recommend using a structured ‘Kaizen’ (Sino-Japanese word for “improvement”) approach to run a 3P event. This starts with selecting the right team – a mix of people with relevant knowledge and the ability to make things happen quickly. The aim is to use organized creative thinking to develop effective and innovative designs and processes to gain a competitive cost advantage.

During the 3P event, several high-level ideas are identified and grouped before being converted into concepts and ranked. The top-ranking concepts are prototyped, iterated and refined until the optimal outputs are selected and honed to be implemented. Along the journey there is a strong focus on eliminating waste and developing a lean process that can change and adapt rapidly. Visiting ‘gemba’, the actual place where the work is done, is a vital step in this process.

The outputs of this event will include both design recommendations and the framework for the manufacturing process. The 3P team will also develop a process-at-a-glance chart that can be used by the wider development team after the event as a visual guide of the parts and details of the process steps.

Parallel development of the design and manufacturing process from this point allows for rapid integration of both design and manufacturing needs. This will significantly reduce costs compared to a series approach of product design followed by process design.

3. Designing for assembly and manufacturability

Invetech contract manufacturing

Having a manufacturing engineer embedded within the design team during development ensures there is a specialist considering critical items such as design for assembly and manufacturability throughout the process.

Designing for assembly

Assembly, particularly labor, is a significant component in any product’s cost; so, it is important to understand the assembly process long before it begins. One of the primary goals is to eliminate complexity and keep the number of parts as low as possible. Fewer parts can mean reduced manufacturing time and labor costs.

How parts are manipulated during manufacturing is also important. Reducing the number of times a part is handled, ensuring a logical assembly sequence, and designing parts that can only be put together in one specific way will reduce the length of production time and eliminate potential mistakes. You also get the added benefit of a more reliable and robust design.

Designing for manufacturability

When designing for manufacture (DFM), a manufacturing engineer can help ensure all of the components in the design are compatible with the most appropriate and cost-effective manufacturing processes.

Some of the ways design and manufacturing team collaboration can build simplicity into the product design include:

      • Minimizing the number of parts, especially moving parts
      • Combining functions/parts (e.g. using one part for several functions)
      • Eliminating unnecessary features
      • Defining and adding assembly features into parts.


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4. Sourcing parts and establishing your supply chain early

By far the biggest impact on the cost of a device is the bill of materials (BOM). Therefore, when it comes to sourcing parts, supplier selection is critical when making the trade-off between low cost and required quality.

Choosing suppliers with care

Manufacturers and other suppliers must be vetted closely to determine if they’re a good fit.

      • It’s important to understand each vendor’s capabilities to ensure they can make components correctly and in the appropriate volumes. How are price breaks structured? How many parts must be manufactured before costs come down? What is the company culture like? What is their quality reputation? Is quality a cornerstone? Do they take a proactive approach to ensure high-quality parts?
      • Having established supplier relationships significantly enhances agility and speed during development and manufacturing establishment. Where new suppliers are required, agreeing to key items early (costs, lead times, etc.) is critical, while also allowing for an element of flexibility for an evolving design.
      • When possible, it is important to develop parts that are easy to manufacture and don’t require special processes. Production simplicity can widen the field of possible vendors, making it easier to find the right ones.
      • Raw material costs also play a significant role in a device’s ultimate price. A vendor may come in at the lowest price, but shipping costs, tariffs, and other factors may eliminate that advantage.

Building relationships is the key to sourcing suppliers and materials. References and site visits are a great place to start.

Identifying critical components early so they can be managed

All products have critical components. These are items that are not only critical to the function of the diagnostic device but may be difficult to source or have quality requirements that make them complex to make. These items need to be identified early so they can be managed.

These critical components are generally expensive due to the nature of what function they provide. Identifying and establishing suppliers for these components is extremely important to keep the cost down and establish quality requirements and lead times up front. A supply issue with a critical component during production will add substantial cost if alternative rapid solutions are required.

Procuring parts for prototype builds through the manufacturing supply chain

To reduce risk of any supply chain issues at the start of production, it’s beneficial to have the manufacturing facility procure as many parts as possible for the final prototype builds. This is possible through effective design transfer planning.

In a manufacturing environment, incoming goods inspection is critical to prevent poor quality material getting to the assembly line. Using the manufacturer to procure the parts not only allows the supply chain to be established, but also the incoming inspection process to be developed. Doing this for prototype procurement allows the opportunity to address issues before reaching production.

5. Refining the process to improve quality and repeatability

point of care diagnostics assembly and manufacturability

Increasing quality and efficiency of the build process

As the manufacturing process matures, it will evolve into a formal build procedure. All too often, companies will wait until the end of the design stage to develop this procedure, missing the opportunity for considered iterations. This results in an inefficient process with an increased likelihood of quality issues that will add to the cost for the life of the product. In the case of a medical device that has been released and validated, a change to the build process can trigger re-validation – a cost that may not justify the future savings.

A better approach is to have the build procedure ready to use for the several prototype builds of the design. This will allow the design and manufacturing teams to use the build process during the development stage and work together to refine it over several iterations. By finding ways to increase quality and efficiency during these very important prototype builds, companies can achieve significant ongoing cost savings.

Improving quality and repeatability using PFMEA

Once a high-level build process is developed, we use PFMEA (Process Failure Mode Effect Analysis), a tool that is used to identify potential quality risks in the process and prioritize those risks based on the severity and occurrence.

PFMEA allows the development team to focus on the most significant items, and, where possible, eliminate the potential for quality issues in the design. This reduces cost in both development and production by focusing design effort only where it is needed and minimizing the potential for rework or scrap on the assembly line.

The side-benefit of this process is reduced complexity during the manufacturing process, as it is often the complex steps that introduce the most risk and cost during production.

Advantages of integrated design and manufacturing teams

Significant cost savings can be achieved when the design, engineering and manufacturing teams work together throughout the product development process. When those teams are also tightly integrated under one “roof” – it’s even better. Below are just some of the advantages of integrated teams.

      • Right advice at the right time. Having a manufacturing engineer embedded with the design team allows rapid decisions to be made. The development can also be guided in a direction that is compatible with manufacturing.
      • More seamless transfer to manufacture. Utilizing one team with established communication channels, standardized documentation formats, and shared processes significantly reduces the ramp-up time for a more seamless transfer between development and production.
      • Single point of accountability. There are several activities during the transfer and establishment process where handover of responsibility and ownership occur. Having an integrated team ensures accountability and any potential risks can be addressed by the team before the start of production. Furthermore, having a manufacturing engineer who’s worked with the development team during the project is an important asset during manufacturing establishment.

Having a manufacturing mindset from the start of the product development process, utilizing design for manufacture tools, establishing a supply chain early and refining the process for repeatability all contribute to the manufacturability of a product. Rigorous planning and embracing a process that integrates the design, engineering and manufacturing teams are keys to increasing efficiency, and ultimately, lowering the cost of POC devices.

Learn more about our POC product development process and contract manufacturing services.

Guide: Best Practices for Point of Care Product Development

For strategies on how to accelerate timelines and decrease costs, download our Best Practices for POC Product Development Guide.