Medical Products & Devices

The Austin Company provides innovative design-build solutions for the medical product and device industry, including facilities for cosmetics and cosmeceuticals production and related laboratories. Austin recognizes the importance of understanding the technical requirements of the medical products industry and ensuring that facilities-related services are both compatible and complimentary, while also responding to unique client sensitivities. Our successful approach for these facilities includes adopting new technologies, responding to ever-increasing compliance constraints, and achieving results on-time and within budget. Austin’s service methodology, The Austin Method®, is a project approach that stresses front-end planning, establishes a fixed cost early in the process, reduces clients’ exposure to risk, provides single-source responsibility, and reduces change orders and schedule delays.

Medical device manufacturers are faced with great opportunity for contract manufacturing of Class II medical devices, and will be characterized by cost containment and product differentiation. A majority of medical device manufacturing occupies “near-clean room” facilities, likely ISO 9 equipped with durable and cleanable surfaces. It is anticipated that requirements will drive facilities to at least ISO 8, with ISO 7 in localized areas. Austin’s proven experience with pharmaceutical and food and beverage facilities includes design and construction of clean rooms up to ISO 4. Austin professionals are skilled and up-to-date with the latest technology and regulations. In addition, we help clients evaluate sustainable design options, including energy efficiency measures to reduce energy consumption.

Austin’s team of architects, engineers, and construction professionals has extensive experience in satisfying complex cGMP manufacturing facility requirements, providing a complete and coordinated solution that integrates the building, infrastructure, process and business requirements for each facility.

Contact Jim Cathcart for information: jim.cathcart@theaustin.com or 949.451.9000.