Development of specialty drug delivery systems requires both strong materials and mechanical engineering expertise. And, in some projects there can be additional constraints tied to existing supply chains or preferred materials. This white paper looks at the process Forefront Medical Technology used in designing a Class III drug delivery system used in a chemotherapy application.
In this case the customer was a Tier One contract manufacturer, who built specialty kits for an original equipment manufacturer (OEM) of specialty drug delivery systems. The contract manufacturer was looking for a medical disposable manufacturer in Asia who met FDA regulatory requirements and could supply required components for their production operations using OEM-specified materials. The contractor also wanted the supplier to provide long-term cost reductions in line with the OEM’s requirements.
The customer provided the basic design for the mechanism and the components. The key design challenge involved identifying materials that met the customer’s requirement of Di 2-ethylhexyl phthalate (DEHP)-free and had the required bonding strength among components and tubes. This was complicated by the fact that one component supplier had been previously selected by the OEM and any design modifications would need to incorporate that component and supplier. Read more:
One of the key challenges facing medical device manufacturers is determining the optimum mix of mold cavities and machines. High cavity molds enable medical manufacturers to tap economies of scale when fabricating high volume single-use products by reducing the number of machines needed to achieve required production volumes. However, increasing the number of cavities also can increase the project complexity. Forefront Medical Technology recently designed a 64-cavity mold for a customer. This case study looks at the challenges and lessons learned in the project.
Read more here.