Medical Device, Product Development, and Manufacturing Services
Join Our Newsletter - Get important industry news and analysis sent to your inbox – sign up to our e-Newsletter here

Pivot International

Medical Device, Product Development, and Manufacturing Services

Pivot International (Pivot) provides product development and manufacturing services of medical devices for customers and applications worldwide.

11030 Strang Line Rd,
KS 66215,
United States of America

11030 Strang Line Rd,
KS 66215,
United States of America

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

About Pivot

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).

Cril – N Tidal B

After winning the "Photonics for Health" Innovate UK competition, Wideblue led a consortium with GSS and CRiL to develop a new range of medical device products - Solid State Optical Respiration Capnometer (SOSORC).

Zibrio Balance Scale

This medical camera merges data acquisition with storage and management via a web application. It allows physician-to-patient sharing, synchronization of patient folders, and HD image or video transmission by a secured connection to a referring doctor – anytime, anywhere. The camera offers a unique experience with a removable LCD touch screen. This first-to-market concept allows the surgeon to instantly share and review their findings with the patient and colleagues locally or remotely.

Patient Prescription Adherence

This sensored prescription bottle continuously monitors prescription drug usage to ensure the proper rate of consumption, improving patient outcomes. Monitoring data is directly uploaded to the cloud after each bottle usage, with sensor sensitivity capable of measuring a fraction of a single pill weight. The device’s form factor and appearance are that of a typical prescription bottle, with miniaturized electronics in the base of the bottle supporting >60-day prescription for most pill types.

Peek Retina – Low-Cost Ophthalmoscope

Peek Vision is a social enterprise and UK registered charity comprising of technologists, eye specialists, and product designers who are passionate about making high quality eye care available to everyone. Peek approached Wideblue, a subsidiary of Pivot International, to develop a low-cost ophthalmoscope to help bring essential eye care to low-income countries such as Tanzania.

IMPOSSIBLE – I-1 Instant Camera

Late in 2008, The Impossible Project took over part of the last Polaroid integral instant film manufacturing plant and reinvented a totally new instant film for traditional Polaroid cameras.

Centeo – Portable Temperature Control Unit for Testing

Centeo Biosciences conceived the TG40 System, a portable unit that allows scientists to control the temperature of protein crystallisation samples during experimental procedures. The device had to have a high degree of temperature uniformity and setpoint accuracy to ensure optimal crystallisation.

CALCIVIS – Dental Imaging Device

The CALCIVIS imaging device is a specialised device designed exclusively to image the tooth after delivering an application of CALCIVIS photoprotein. The handheld medical device is initiated via a 'one-touch' computer-controlled process. A specialised sensor integrated into the device immediately detects the resulting luminescence (light flash), and in less than one second, bespoke software presents a chairside demineralisation 'hotspot' image map to clinicians, enabling informed and efficient dialogue with patients.

Reprocell Europe – Preclinical Drug Trial System

ReproCELL Europe's PM1 instrument provides real-time information on drug potency by measuring changes in the shape and form of isolated blood vessels during a pre-programmed perfusion schedule.

Cril – N Tidal B – Personal Capnometer

After winning the "Photonics for Health" Innovate UK competition, Wideblue led a consortium with GSS and CRiL to develop a new range of medical device products - Solid State Optical Respiration Capnometer (SOSORC).

Anasyst – Point of Care Sepsis Detection

As part of a proof-of-concept feasibility study, Wideblue worked with Anasyst and the University of Teesside to design a point-of-care technology demonstrator for the early detection of Sepsis.

How WiscMed and Pivot Partner to Change the Face of Paediatric Care

When Wisconsin-based WiscMed co-founder and Wispr-inventor Dr James Berbee decided to take on the formidable challenge of pursuing a medical degree from Stanford at age 42, little did he know he’d be behind a medical innovation six years in the making that would advance the standard of paediatric care.

Pivot International

11030 Strang Line Rd


KS 66215

United States of America

Pivot – United Kingdom

Kemp House

152-160 City Road



United Kingdom

Pivot – A2E Limited

Alba Innovation Centre

Alba Campus


EH54 7GA

United Kingdom

Pivot – Avatar

23875 West 83rd Terrace Shawnee

Kansas 66227

United States of America

Pivot – Castle Creations

540 North Rogers Road Olathe

KS 66062

United States of America

Pivot – DigitTron

23875 West 83rd Terrace Shawnee

KS 66227

United States of America

Pivot – EDM

12202 Cary Circle La Vista

NE 68128

United States of America

Pivot – MCC Electronics

1200 SE Century Drive Lee’s Summit

MO 64081

United States of America

Pivot – Solar Pool Technologies

2114 E 5th Street Tempe

AZ 85281

United States of America

Pivot – Wideblue

Kelvin Campus

Maryhill Road


G20 0SP

United Kingdom