Meticulous design & development for medical devices

As early as possible. Our expert team can assess the manufacturability of your proof of concept (POC) or existing design and provide feedback on potential design issues, manufacturing or scalability challenges, and cost implications. We can design a POC or proof of principle (POP), help you assess feasibility, and produce prototypes or models that demonstrate key features, functionalities, and performance characteristics. We can also provide guidance on material selection, recommending materials that meet the desired performance criteria, regulatory requirements, and cost considerations.

From there, we help 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 or maintaining existing ones, adding process validation for consistency, and expanding quality control measures.

Absolutely. With a global network of FDA/ISO-certified facilities, we help clients design prototypes, develop processes, and build and launch products in full compliance. Our team also considers factors such as materials, labor, and overhead expenses, evaluating the economic feasibility of the project. Once your process has been thoroughly tested, Ascential assists you in a careful roll-out that prevents downtime and errors.

Beyond your production lines, our team also builds processes for supply chain and inventory management, minimizing risks and disruptions.