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Consumable A/pH Sensors for Dialysis – From Multiple, Manual Processes to a Faster, Automated Manufacturing Line While Maintaining Critical Tolerances and Mitigating Safety Risks
September 25, 2024
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Design and Development
Medical manufacturing requires the management of every aspect of production through careful planning, design, and development. Every stage of your operation can present an opportunity for optimization and growth, but it can be challenging to scale up the expertise, resources, and capabilities needed to capitalize on these opportunities. From prototyping to designing for manufacturability to optimizing equipment and processes, the Ascential team can help with one aspect of your project or deliver a full, end-to-end solution.
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Why Ascential Design and Development?
No matter how complex your design or manufacturing challenge is, the Ascential team is ready to help. Our deep bench of experts works cross-functionally to help you optimize product design, streamline manufacturing processes, and ensure regulatory compliance, all while driving innovation forward. By collaborating with our team, they can help you accelerate time to market, reduce costs, and enhance the overall success of your products in the marketplace.
Process Development
Developing your manufacturing process and implementing it effectively involves planning, coordination, and a clear roadmap. Our experts can help identify your current state, goals, and the steps required to achieve them. Starting with an assessment and goal definition, they help you develop a cross-functional team to support your process, identify and evaluate new technology and vendors, and conduct feasibility studies. Together, our team works with you to design and map out the new process, then test it with a prototype and/or pilot program.
Once the process has been thoroughly tested, Ascential helps you prepare your team for success through training and documentation, then assists you in a careful roll-out that prevents downtime and errors. When you are up and running, our team can continue to support continuous improvement and ongoing monitoring to provide reporting and insights for further optimization.
This pathway is proven to future-proof your operation, laying the foundation for scalable growth.
Proof of Principle/Concept and Pilot Lines
When you need help bringing your ideas to life (or getting them from the lab to patients), our expert team is here to help. They can assist in designing a proof of concept (POC) or proof of principle (POP), helping you assess the feasibility of the concept. Using our manufacturing capabilities, they can produce functional prototypes or models that demonstrate key features, functionalities, and performance characteristics.
Through collaborative problem-solving, our experts address technical challenges, iterate on design, and refine the prototype. This approach allows for rapid iteration and refinement, leading to the development of a robust POC or POP that meets your objectives. They can also provide guidance on material selection, recommending materials that meet the desired performance criteria, regulatory requirements, and cost considerations.
Pilot lines can also be useful to produce limited quantities of a product for testing, validation, and market introduction purposes. Our experts design pilot lines to bridge the gap between prototype development and full-scale production, allowing you to assess manufacturing processes, optimize production workflows, and validate product quality before ramping up production volumes. They can provide equipment, tooling, and process expertise to establish pilot production capabilities that mirror full-scale manufacturing processes.
Pilot lines are particularly valuable for verifying manufacturing scalability, conducting regulatory validation studies, and performing market trials to gather real-world feedback from users and stakeholders. Once the product has been successfully validated, you’ll be ready to scale up production to full capacity.
Design for Manufacturability
Our expert team can assess the manufacturability of your POC or existing design and provide feedback on potential design issues, manufacturing or scalability challenges, and cost implications. By evaluating the design for manufacturability (DFM), they can help you make informed decisions and optimize the design for production.
Ascential provides feedback on the design to optimize for efficient assembly, reduce complexity, and minimize production costs. Our team also considers factors such as materials, labor, and overhead expenses, evaluating the economic feasibility of the project. Our highly skilled engineers are available to make design changes to optimize the DFM, keeping your project under one roof. Working together, Acsential can help ensure that the design is optimized for efficient and cost-effective production without compromising quality.
Our team also offers regulatory guidance and support, advising on regulatory requirements and documentation needed to demonstrate compliance and facilitate regulatory approval.
Equipment Optimization and Ramp-Up
These processes maximize the efficiency, performance, and output of your manufacturing equipment and facilities in order to meet production goals and scale up production volumes. Our team designs processes to ensure that your manufacturing operations can meet demand while maintaining quality, compliance, and cost-effectiveness.
Our experts optimize your equipment to increase efficiency, reliability, and utilization. This may include preventive maintenance, calibration, and troubleshooting to minimize downtime and maximize uptime. Additionally, equipment optimization may involve process improvements, automation, and workflow optimization to streamline production processes and eliminate bottlenecks.
To meet growing demand for your products, you need the right processes to be ready to ramp up. Ascential helps you to scale up production capabilities, adjust workflows, and expand capacity to accommodate increased production requirements. This may involve training personnel, implementing new equipment or production lines, adding process validation for consistency, and expanding quality control measures. Beyond your production lines, our team also helps with processes for supply chain and inventory management, minimizing risks and disruptions.
