Managing risk is crucial to businesses working at the forefront of innovation in the diagnostics and lifescience device industry . In this article, we provide some guiding principles to de-risk your microfluidic product development program.
When it comes to managing and mitigating product development risk, there are six guiding principles that are proven to work. Taking a holistic approach and mapping out the pathway to success at the beginning of the program provides much-needed certainty about both the journey and the destination. These guiding principles will help lead you to success.
MICROFLUIDIC PRODUCT DEVELOPMENT Risk management – 6 guiding principles
- Plan for success
- Choose the right team
- Commercial considerations
- Use a stage-gated process
- De-risk concurrent design
- Design for manufacture
PLAN FOR SUCCESS
At the start of a project, it is critical to define the product concept and align the project tasks and teams to achieve the best possible commercial outcomes. It is important to create a detailed, robust plan for the product development program based on an agreed set of requirements that have been market-driven.
A typical product and project definition stage involves the following activities:
- Assess and clarify the technical, market & VOC input
- Create and agree on design requirements
- Create design architecture and concepts
- Identify technical and project risks
- Establish what proof of principle concepts are needed for risk mitigation
- Develop the manufacturing strategy based on the design architecture
- Based on concepts and associated risks, establish the testing methods and acceptance criteria for subsequent development activities. Then put together a detailed and costed development plan.
The outputs of the planning stage are used to assess the feasibility of the product and project against the business plan and stakeholders to ensure commercial alignment.
CHOOSE THE RIGHT TEAM
Involving the right experts at the right time throughout a project is critical to achieving a successful program outcome. These projects are complex, and a multidisciplinary approach is needed to make them a success. Input from Marketing, Product Managers, Project Managers, Product Designers, Microfluidics Engineers, NPI and Automation Engineers, Scientists, Biochemists and regulatory experts are all needed.
Although this may seem obvious, it is often overlooked that much of the key design input is required at the very start of the project.
Considering product-market fit early de-risks your product development program and increases the likelihood of your product being a commercial success. The product-market fit is a process that helps articulate the key assumption that underlies why and how a customer is likely to use the product. Identifying a compelling value that clarifies the features you need to build, the audiences’ needs, and the business model required to entice a customer to buy your product.
Before beginning the physical aspects of prototyping and testing a product, the following commercial questions must be answered to ensure business plan alignment:
- the value and timings of funding requirements
- tasks, timelines and major milestones
- initial assessment of the design achieving the product requirements having an initial assessment of the market acceptance, typically through VOC work on the product concept
- establishing the ROI
Use a stage-gated process
A stage-gate process is a method of moving a development project from idea through to launch, where pre-defined tasks are completed in each stage prior to gaining approval to proceed to the next development stage. Operating a staged development process in-line with regulatory requirements and proven project management practices helps de-risk the development program by ensuring you have the right inputs, and that the key experts and stakeholders are aligned, prior to starting each stage of the development.
An example of a stage gated process for a microfluidic cartridge development is shown below:
De-Risk Concurrent Design
The proven product development hierarchy is that assay leads microfluidic cartridge development which leads the instrument. This approach leads to reducing the risk of uncovering problems or design flaws too far down the program pathway. Because the product development process involves multidisciplinary teams, it is important to collaborate early and comprehensively to balance design risk reduction with time to market demands. To do this the right experts need to communicate regularly and have a set of working documents to define the system architecture, system interfaces, project risks, product requirements, program timelines and milestones.
Design for Manufacture
DFM needs to be considered at the beginning of the project to ensure the product design and processes used are scalable for manufacture. Making changes to a design not only increases the time to market, but it becomes more expensive as you progress through the development stages. Therefore the following DFM strategies should be considered early in the product development process.
1) Make sure manufacturing can be scaled as needed
Carefully plan to scale manufacturing according to market demand and lead times, CAPEX expenditures & COGs trade-offs. Understanding this at the outset allows the designers to ensure the DFM decisions appropriate with each stage of manufacture are incorporated into the product from the outset.
2) Use proven and verified processes and components
This can significantly reduce time, cost and uncertainty as compared to developing new solutions.
3) Reduce the number of parts and processes
Manufacturing cost savings and product reliability can be improved by the appropriate reduction in parts and manufacturing processes. By reducing the number of components not only is the cost associated with the number of parts reduced, but also the costs associated with number of manufacturing process steps and the costs of managing the supply chain.
4) Design for compatibility and the Utilisation shared infrastructure pilot lines
For small production volumes (sometimes up to several 100k's of parts) it can be beneficial to share production line infrastructure with other products. This can lead to accelerated lead times due to infrastructure already in place, and a lower COGs due to the amortisation of overheads over more products. For these production volumes it is usually more cost effective to ensure the part is aligned with the existing manufacturing infrastructure.
5) Design in the appropriate manufacturing controls
Manufacturing controls are vital to ensure the product meets specification, every time. Managing design so that these controls do not over-complicate the manufacturing process requires experience.
6) Use established supply chains
When manufacturing a product, it is critical to establish strong supply chains for the input materials to ensure the appropriate quality and continuity of supply. In microfluidic manufacturing, there are many quality requirements (such as surface energy and material auto-fluorescence) that are often not known or normally checked by suppliers. Therefore, it is critical to choose your suppliers carefully, and in many instances work with them to establish the appropriate quality controls.
Mitigating and managing product development risk is about taking a holistic view, making the right critical decisions up-front and working within a proven process framework. By following these six guiding principles, you will be well on your way to achieving a commercially successful microfluidic product.
SCHOTT MINIFAB is the world’s Number 1 contract developer and manufacturer of polymer microfluidic devices for point-of-care life science applications. We have a well-established and proven track record of successful commercialisation outcomes and high-volume manufacture capabilities.
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