In-vitro diagnostic medical devices
Transforming your idea into a clinically relevant tool
![Photo of in-vitro testing in a lab with pipette Photo of in-vitro testing in a lab with pipette](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/GettyImages-924655686-scientist-working-with-pipette-in-lab.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1597345701&s=c5a1b05c424f022ea4f4b14e1e6c50f9 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/GettyImages-924655686-scientist-working-with-pipette-in-lab.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1597345701&s=ba785bfa8548d01f181d8ae05ec11b7a 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/GettyImages-924655686-scientist-working-with-pipette-in-lab.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1597345701&s=af4157940562366378bd70baf6dbc258 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/GettyImages-924655686-scientist-working-with-pipette-in-lab.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1597345701&s=f9d72af815e4c46ad02da030763f6c89 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/GettyImages-924655686-scientist-working-with-pipette-in-lab.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1597345701&s=aeb0f559b97ebdd277d492b82de035e0 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/GettyImages-924655686-scientist-working-with-pipette-in-lab.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1597345701&s=9c0ba9e30794f94e636777db0e3d82d7 960w)
In-vitro diagnostic devices
Developing, testing and deploying commercially successful In-vitro diagnostics (IVD) is a multidisciplinary challenge. In order for a device to be successful we need to bring together a number of complex components including biological materials, physical delivery methods, sensing, signal amplification and often digital elements to enable integration with apps and digital healthcare records. Further complications are added by the fact that these elements must be brought together to function as one, under the correct regulatory conditions. And it doesn’t stop there, device developers need to be connected into the right individuals and groups within the healthcare ecosystem such as patient groups and healthcare providers to help with market adoption.
![Photo of scientist in lab with microscope and colleagues Photo of scientist in lab with microscope and colleagues](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-Sedgefield1500.249.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1597354759&s=451175135bd1f929fd810a7d2fe3511a 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-Sedgefield1500.249.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1597354759&s=ed1b1f229d6b769d3a586772afaf076a 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-Sedgefield1500.249.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1597354759&s=60464275ef9a8bf4be35dc6fb044330a 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-Sedgefield1500.249.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1597354759&s=72a1f0f7639369b719b62f3f86e09f2b 960w)
At CPI we have multidisciplinary teams with a broad range of capabilities who can work across the spectrum to drive progress and accelerate the development and scale up of your diagnostic device. We are well connected into the healthcare and innovation ecosystem and can help you to take your concept right through to commercialisation.
Supporting you with horizontal innovation
At CPI, we have expertise in working across the biological, physical and digital space for IVD, as shown in our (non-exhaustive) set of capabilities. Our skilled scientists, engineers and data experts are adept at horizonal innovation, bridging capabilities across the often isolated biological or physical sciences.
![Image showing how horizontal innovation works Image showing how horizontal innovation works](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/IVD-Slide-Fudge.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1597840557&s=c02ff860e72ed9d61832080f26055231 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/IVD-Slide-Fudge.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1597840557&s=018432d845cf978e9c8819bc4ee1fc7b 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/IVD-Slide-Fudge.jpg?w=2240&h=1260&q=45&fm=jpg&fit=crop&dm=1597840557&s=ed531c7e7021147c7d62d989497a3748 2240w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/IVD-Slide-Fudge.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1597840557&s=28962cff08ef2087148b89a1ed7e1d69 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/IVD-Slide-Fudge.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1597840557&s=a592d292f9f139912e9548e929105c64 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/IVD-Slide-Fudge.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1597840557&s=2ab6bb37f2e464543dca241469d49294 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/IVD-Slide-Fudge.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1597840557&s=f890f38d0534a465e76f08507ff4cbc6 960w)
Do any of these apply to you?
Support with device development and manufacture.
Would you like to scale up your disposable components or consumables?
We have significant capabilities in roll-to-roll manufacturing for disposable elements of IVD such as those which involve electrodes, sensors or delivery systems. Our world-leading roll-to-roll equipment can produce up to millions of components or sub-systems to provide market seeding volumes. Roll-to-roll manufacturing offers a route to high volume manufacture and can provide benefits of scale. Our experts have worked in the controlled deposition and patterning of materials across many markets including sensing, displays and medtech. We can work with you from the concept stage through sheet to sheet processes and scale up to large volume with sheet to sheet or roll to roll – transferring the process onto you for commercialisation later.
![Flexible printed labels Flexible printed labels](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/flexible-printed-electronics.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1559221679&s=41293c5b97baf85742b14ffa096ae8e6 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/flexible-printed-electronics.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1559221679&s=aa19bc9eff3e23459a5807eff5a488d2 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/flexible-printed-electronics.jpg?w=2240&h=1260&q=45&fm=jpg&fit=crop&dm=1559221679&s=dc33623a8ccdbfda8f21dcf353959e6f 2240w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/flexible-printed-electronics.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1559221679&s=2c6b1cff47e749de9dfa0cf39b10a3f6 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/flexible-printed-electronics.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1559221679&s=e7d84c7a0acced0001430b92c51beae0 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/flexible-printed-electronics.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1559221679&s=6161501f7c0e2bf64b67f38cbf142c84 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/flexible-printed-electronics.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1559221679&s=e92be156fc7fa14c0b994ba0432efb37 960w)
Do you have an assay that you’d like to develop into a device?
We can work with you to develop integrated mechanical, electronic and optical system design and manufacturing under ISO13485 certified quality management systems. We ensure safety and quality are maintained throughout the process, and you can also use our Quality Management System (QMS) to support your technical file development. We can partner with you from concept through to manufacture of your IVD devices, including performance testing for clinical use and CE marking, and manufacturing within a Class 6 clean environment.
![Craig working in photonics lab Craig working in photonics lab](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-Sedgefield1500.003.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1621502911&s=224eff47ceaf90af60853319b59eee43 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-Sedgefield1500.003.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1621502911&s=433fbe9677965314494e9463b2af2712 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-Sedgefield1500.003.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1621502911&s=3b3f77cf1b806b508aa539c2dd95abd4 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-Sedgefield1500.003.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1621502911&s=31d3e04cac4560d6ecbbf275a46e28e7 960w)
Are you developing a connected device (mIoT)?
With a growth in digital connectivity infrastructure, many companies are developing connected medical devices. The internet of things or the internet of medical things (mIoT) is expected to change the way that healthcare systems operate and will give additional support to patients and their carers. We’re experts in medical device development as well as the Internet of Things and can support you in your development of connected IVD from design through to manufacturing.
![Grandad at home with IoT medical device Grandad at home with IoT medical device](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/elderly-man-with-iot-connected-devices-in-the-home.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1572890720&s=b94b6c2ceaa471f2a1e8d8b2ff0f0e10 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/elderly-man-with-iot-connected-devices-in-the-home.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1572890720&s=c6b2c15a564db338839eb5886a52acf6 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/elderly-man-with-iot-connected-devices-in-the-home.jpg?w=2240&h=1260&q=45&fm=jpg&fit=crop&dm=1572890720&s=32c210015a47cf524e5820c0fce29aaf 2240w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/elderly-man-with-iot-connected-devices-in-the-home.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1572890720&s=cdd546665bd0a4e066303b2c271c6de8 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/elderly-man-with-iot-connected-devices-in-the-home.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1572890720&s=7794c23ea7699e262760956fd0a7f13b 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/elderly-man-with-iot-connected-devices-in-the-home.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1572890720&s=843fcaf7d93d143c0c208623e9ec204a 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/elderly-man-with-iot-connected-devices-in-the-home.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1572890720&s=1aede778e9824fd0fcbaa88f5e9e3a15 960w)
Would you like to develop IVD delivery systems?
With our world-leading capabilities in high-volume printed electronics, we can help you to develop and scale processes for material delivery. This can include the development of technologies such as droplet-based manipulation through techniques such as electrowetting. We have expertise in printing and patterning of materials onto flexible or rigid substrates and can help you to develop the correct layer quality, microstructure and interfaces.
![Printed electronics clean room Printed electronics clean room](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/printed-electronics-cleanroom.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1559216789&s=2d7f580c615d283bb05eaea462951628 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/printed-electronics-cleanroom.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1559216789&s=6d1b3dbe627e583834394c691a553ce1 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/printed-electronics-cleanroom.jpg?w=2240&h=1260&q=45&fm=jpg&fit=crop&dm=1559216789&s=2afd22eea1f804b75fbbd19a2830c888 2240w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/printed-electronics-cleanroom.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1559216789&s=4e0d415b5da2098463e5f5d3dbbd562c 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/printed-electronics-cleanroom.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1559216789&s=93846a77afe554bbcfc70f215c99ecaf 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/printed-electronics-cleanroom.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1559216789&s=a7439aa976c11e9acd1d13e756e4689e 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/printed-electronics-cleanroom.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1559216789&s=c306ebe0ee8a5f69bfee40b62704960e 960w)
Do you need support in measuring your analyte-bioreceptor reaction?
We can work with you to develop a solution to measure or monitor the reaction through sensing technologies such as those that measure electrochemical or optical changes. With our expertise in printing and patterning, including fine line lithography, we can develop and scale electrode structures and combine them with the correct sensing systems and signal processing improvements.
![](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-Sedgefield1500.121.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1597352608&s=4a78ebe72773545f892b46fdc31d63df 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-Sedgefield1500.121.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1597352608&s=8ceba3c61be85e64d759badabb0b9cd5 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-Sedgefield1500.121.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1597352608&s=9475738810cdde5aeee994cfef3790ea 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-Sedgefield1500.121.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1597352608&s=48773f5adfa863e6777b67d0565039da 960w)
![Cheryl Dean Cheryl Dean](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/C-McGee-Photo.jpg?w=400&h=400&auto=compress%2Cformat&fit=crop&dm=1625564237&s=787b3950765ca6c7d5b0901cf7db8db6)
Are you looking for support with assay development
Our expertise in assay development means we can de-risk your technology development.
Do you need access to human tissues or materials?
We have a broad range of capabilities to support you to develop your assay and optimise parameters such as sensitivity, limits of detection, dynamic range and specificity. We can enable pre-clinical validation on a variety of human tissues (blood, urine, saliva, sputum, etc.) within our HTA Licensed CL2 Biolab facility.
![Deepan in lab Deepan in lab](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-SedgefieldHigh_215.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1580746927&s=df2a250af04becdb3463758b4de48467 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-SedgefieldHigh_215.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1580746927&s=4590e7e48660d68121496344b48ae755 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-SedgefieldHigh_215.jpg?w=2240&h=1260&q=45&fm=jpg&fit=crop&dm=1580746927&s=ecbb104f73bb654c8eb5334d5c5f2915 2240w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-SedgefieldHigh_215.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1580746927&s=bfbeb5ca8129b81e7d88a0a6e09f1bb7 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-SedgefieldHigh_215.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1580746927&s=94dcc0d9e4d23a96be504d4f1e356587 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-SedgefieldHigh_215.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1580746927&s=77736461efc043356838db8ac925f181 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/191126CPI-SedgefieldHigh_215.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1580746927&s=9948a9dae02b0046bf2ed8114e734ed7 960w)
Are you developing an assay that requires labelling for signal amplification?
If your diagnostic system requires labels such as nanoparticles, enzymes or fluorescent molecules we can help you to not only develop and scale these materials but also conjugate them to your targets. Using our suite of optical tools we can measure the performance characteristics of the labels (optical properties, fluorescence lifetimes). With our confocal microscope suite, we can help you to understand specificity, cellular localisation and other relevant data to support the faster development your IVD device.
![fluourescent molecules fluourescent molecules](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/GettyImages-1184711342-fluourescent-imaging-of-cancer-cells.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1597345713&s=0578ba074f24f0058faf999f962499e4 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/GettyImages-1184711342-fluourescent-imaging-of-cancer-cells.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1597345713&s=c059271037c217d8890b8a7e94ae4445 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/GettyImages-1184711342-fluourescent-imaging-of-cancer-cells.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1597345713&s=6ffcbd6ba4a9ea96b9f65285666f5bd7 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/GettyImages-1184711342-fluourescent-imaging-of-cancer-cells.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1597345713&s=83b3674fa79a39a30f0e6f17c1e5901a 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/GettyImages-1184711342-fluourescent-imaging-of-cancer-cells.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1597345713&s=7f3d4cc7936a1b919c37a833549cd0ba 960w)
Do you need to scale up your analytes?
If your bio-reagent manufacturing scale is not suitable for your addressable market, we can help. We have a full suite of biotechnology and fermentation facilities to develop and scale processes from a millilitre up to ten thousand litres. We can help you with upstream (molecule manufacturing) and downstream (purification) processes to ensure that your molecule manufacturing process is at the correct quality, yield and scale for market entry.
![Microscope Microscope](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/microscope.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1559213548&s=a5d1c1e487e98e4d7bb0bb7e0e7130c6 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/microscope.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1559213548&s=98d4798599b533cbbd7257e3b2c46f7f 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/microscope.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1559213548&s=c734f41a4f4088ea3b71cb0e95cf57b8 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/microscope.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1559213548&s=a271ee116df2e12d3eca7e5eacf8116f 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/microscope.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1559213548&s=2eb8f8fac12f488be5146fe6ff6bad03 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/microscope.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1559213548&s=742675091b2b9caab75beb06c9fae63c 960w)
Our capabilities
Talk to us
Have you created an assay that you want to develop into a medical device? Or have developed part of the components or systems, such as a new type of sensor, and you need help to understand which assays it can be used with – we work with companies of all sizes, simply get in touch to speak to one of our experts.
If you’re a large medtech company and you’re interested in new product development that uses novel technologies such as printed electronics or photonics, we’d be happy to have a chat to see how we can help you develop and scale these technologies to help you build your internal business case.
Let’s innovate together
Contact UsLet’s innovate together
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