Regulated Product Manufacturing
120,000 sq. ft. of fully-equipped facilities manufacturing FDA regulated products across the USA and Australia.
Planet Innovation is a contract manufacturer of healthtech products and consumables. The team has considerable experience managing ISO 13485:2016 and ISO 9001 compliant medical device contract manufacturing utilizing lean manufacturing principles.
As a full-service contract development and manufacturing organization, we provide seamless transfer to manufacture and early-stage batch manufacturing, through to at-scale production.
Our manufacturing facilities
PI has 120,000 sq. ft. of fully-equipped manufacturing assembly space in Irvine, California, and Melbourne, Australia. The sites are FDA registered and ISO 13485:2016 and ISO 9001 compliant for manufacturing regulated instruments and consumables. We also have ISO 7 certified cleanrooms to manufacture consumables, along with wet labs and warehousing space.
Book a tourManufacturing Capabilities
Instrument Manufacturing
At our manufacturing facilities in Irvine and Melbourne, we produce products ranging from low to high volume builds, low-complexity devices to large floor-standing in vitro diagnostic (IVD) instruments.
Consumable Manufacturing
We have two ISO 7 certified cleanrooms to manufacture consumables. We are experienced in processes including solvent bonding, ultrasonic welding, leak testing, air particle testing, heat sealing, gamma sterilization, bioburden and sterility testing.
Planet Innovation are experts on how to manufacture high quality, regulated healthtech products so they can be brought to market quickly and cost effectively. This includes supply chain establishment, designing the method of assembly and developing and implementing process controls.
Lean principles
We apply lean manufacturing principles to achieve improvements in productivity, quality, reliability and lead-times by eliminating waste and optimizing operations. These principles include single-piece flow, visual management, Kanban materials supply and continuous improvement.
Flexible and responsive service
We offer tailored supply and quality agreements with high levels of transparency and flexibility to meet the individual needs of our clients. Our dedicated Product Managers have technical and commercial capabilities, with a strong emphasis on frequent communication.
Concurrent engineering and manufacturing
During product development, our manufacturing team works side-by-side with our design and engineering teams. Bringing a production focus to early design decisions results in higher quality products and faster transfer to manufacture. Once in production, the engineering team is available for product support and product enhancement.
Our Experience
Diversified manufacturing portfolio:
PI manufactures medical products for use in various regulatory jurisdictions including the US (FDA), Europe (CE), Australia (TGA), Canada (Health Canada) and the APAC region. These include low risk devices to higher risk IVDs and medical devices.
Video Series
Kurt Pickle, Senior VP of Manufacturing Operations at Planet Innovation discusses our approach to contract manufacturing.
Mature quality systems
PI manufactures high quality, FDA regulated products under mature, audited quality systems. Our facilities are ISO 13485:2016 & ISO 9001 certified.
PI collaborates with clients across the globe, gaining experience with diverse quality management systems, certifying agencies, and regulatory bodies such as BSI, TUVRheinland, UL Solutions. We undergo regular audits alongside our clients and their notified bodies to fulfil obligations, ensure compliance, and establish ourselves as an essential design and manufacturing partner. This process enhances our quality systems, ultimately benefiting all our clients.
Manufacturing Quality Engineering & Assurance
Contact Us
Learn more about our expertise in regulated product manufacturing.
Contact us to book a tour of our Californian or Melbourne manufacturing facilities or to discuss how Planet Innovation’s manufacturing offerings can help your business.
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