An entrepreneur devoted his career to creating products to protect newborns and infants. He identified a new opportunity in birthing centers to improve workflow in birth wards for mothers recovering from c-section births, reducing drops of infants, improving patient satisfaction, and reducing the burden on hospital staff. The company previously sold commercial, non-medical products and did not have the experience in the product requirements and regulatory pathways for medical devices. They had a Class II medical device concept but no path to design, validate, approve, and produce a solution for the healthcare market.

MPE created design concepts and prototypes that we knew would be viable in a medical environment. MPE built functional prototypes and conducted VOC activity on behalf of the customer to validate and refine the design with all hospital stakeholders. Customer leveraged MPE’s QMS and guidance to navigate regulatory requirements. MPE provided 3PL services to warehouse and ship directly to the customer’s end users. MPE used strategic sourcing to hit product launch and design to cost goals.

Initial concept was transformed to a product that better fit the intended environment and workflow. Product was brought to market with 510(k) approval within 14 months of initial engagement. Launch year to following year, sales increased 385% without requiring customer to create any infrastructure to support scale. Product success led to partnership with major medical OEM.

Better products protect the market position and open additional revenue growth opportunities

Proactively offering cost down options throughout the product lifecycle - TCO

VAVE outcome - takes costs out of the products while maintaining product integrity

Continuity of supply

MPE’s investment in CapEx

Mitigation of component obsoletion