Pivot International (Pivot) provides product development and manufacturing services of medical devices for customers and applications worldwide.
Our flexible and knowledgeable team augments our customers’ in-house capabilities throughout the product lifecycle: concept, development, manufacturing, launch, and sustaining. We also provide complete turnkey projects.
Customers range from new inventors to large, well-established firms, and we work to ensure we have the right combination of development and manufacturing skills to serve them all well.
Development of medical products
Pivot’s product development team has decades of experience successfully deploying hardware, software, mechanical, and industrial designs for medical products.
We skillfully integrate the lessons learned from these projects with the latest advances in embedded control, user interface, communications, power management, and motor control to ensure the resultant product is not only fit for purpose, but also reliable, manufacturable, and competitive.
Manufacturing capabilities for medical products
One of Pivot’s core values is flexibility, which is evident in our approach to manufacturing. We design our manufacturing strategy to adapt to our customers and scale as they scale, providing a full range of medical device manufacturing capabilities ranging from printed circuit boards (PCBA) to complete product assembly.
Our global manufacturing footprint comprises six manufacturing facilities in the US, Europe, and the Philippines.
We have over 200,000ft2 of manufacturing space and the ability to efficiently scale from prototype quantities as products are developed and launched to mass production as products succeed in the market.
Our facilities include more than 16,000ft2 of International Organisation of Standardisation (ISO) Class 8 cleanroom environment for general manufacturing and 2,100ft2 of ISO Class 7 cleanroom environment for sterile packaging of medical devices.
Global supply chain
Our global footprint gives us and our customers the ability to access the global supply chain. Whether it is components for a PCB, tooling, moulded or cast parts or anything else required by our manufacturing facilities, our supply chain team works to ensure we are sourcing competitively and responsibly.
Recognising the significance of design changes in the regulated medical industry, we also work proactively with our product development team to ensure the most extensive product lifecycles possible and to minimise disruption when changes are required.
Sustainable quality for medical device development and manufacturing
Through our client collaborations to bring a broad range of medical and diagnostic devices to market, we gained hands-on experience working within the various regulatory and quality frameworks for these devices.
Our experience includes:
- European Conformity (CE) marking Class I, Class IIa, and Class IIb devices
- FDA 510(k) applications
- Medical device risk assessment (ISO 14971)
- Technical file documentation
- ISO 13485 quality management system for development and manufacturing
- Medical device packaging and instructions for use
- Design for sterilisation processes
- Verification testing (including testing using ethically sourced human tissue)
- Medical electronic / electrical equipment safety (International Electrotechnical Commission (IEC) 60601) and electromagnetic compatibility
Award-winning innovation in medical technologies
Our innovative applications of infrared, optics, imaging systems, wireless / Internet of Things (IoT), and digitisation in medical applications has earned international recognition for multiple customers and products. Recent awards include:
- 2020 German Design Award
- 2020 Consumer Electronics Show (CES) Health and Wellness Innovation Award
- 2018 European Product Design Award
- 2017 European Product Design Award
Pivot International was founded in 1972 and has evolved into one of the fastest-growing privately held companies in the US.
We facilitated this growth by serving our medical customers, as well as success in other markets such as industrial, agriculture, security, and defence.
The breadth of applications we solve in these markets allows us to complement our medical expertise with diverse perspectives and generate winning solutions for all our customers.
Recent recognition of our growth includes Kansas City Business Journal Fast 50 (#8), Ingrams Corporate 100 – Fastest Growing Companies in Kansas City (#11), and Inc 5000 – Fastest growing privately held companies in the United States (#838).