IMPACT CASE STUDY

From lab to bedside: bringing medical devices to the market quicker

  • 23 January 2023
  • Assistant Professor Nan Zhang
  • Academic, Economic, Health, Technological


Summary

Point-of-care diagnostic devices give rapid and accurate test results, meaning clinicians can deliver faster diagnoses, improving patient outcomes and saving lives. “Microfluidic chips” are a critical component of these devices. They are also used for PCR tests and developing vaccines, as well as making drugs for treating genetic diseases.

But getting these chips from R&D to the market is challenging. Dr Zhang and his team’s research focuses on accelerating that transition. They have developed processes to help diagnostic companies and laboratories bring their diagnostic tests to clinical trials, and eventually to full-scale production. This not only benefits Ireland’s diagnostics and biopharma industry, which profits from faster technological advances, but most importantly it benefits patients through quicker access to improved tools for detecting and treating disease. 

Research description

Point-of-care diagnostic devices improve patient’s lives. They are easy to use, and give rapid and accurate test results without requiring a certified laboratory, enabling healthcare professionals to deliver quicker diagnoses and make faster clinical decisions, which is crucial for saving lives.

So-called “microfluidic chips” are one of the main building blocks of these point-of-care devices. Composed of many tiny channels similar to human blood vessels (around 10 to 100 times smaller than a millimetre in diameter), they can process tiny quantities of fluids, and are widely used in point-of-care clinical and veterinary diagnostics (such as for Covid-19), as well as in drug development, environmental monitoring, and analytical tools.

However, 99% of microfluidic chips developed in research labs fail to reach the marketplace: there are a range of technical and commercial challenges involved in scaling-up manufacturing. Ten years of research in this area (following a PhD and employment in the microfluidic diagnostics industry) have allowed Dr Nan Zhang to resolve these challenges.

His research focusses on accelerating the translation of microfluidic devices from the laboratory to commercial production, by developing ways for companies to fabricate these complex devices without defects, and with low-cost, in a commercial environment. Through this research, Dr Zhang’s team has established technologies and processes for the design, optimisation and prototyping of plastic microfluidic chips, followed by manufacturing at a larger scale and creating close-to-market products.

Dr Zhang and his team have developed one patent (which is being exploited by a NovaUCD start-up focused on designing and prototyping microfluidic devices) and developed a toolkit to scale-up the manufacturing of microfluidic chips. They collaborate with international and Irish diagnostic companies, including Poseida, FPC-DCU, Novus Diagnostics, Cellix and Sintef.

Research team

  • Professor Michael Gilchrist. Contributes to developing the microfluidic manufacturing platform.
  • Professor Fengzhou Fang. Contributes to fabricating precision nickel mould tools.
  • Dr Nan Zhang. Leads a research team of 4 postdoctoral researchers and 10 PhDs and research masters students, all of whom are currently working on various aspects of the manufacturing process chain for novel microfluidic devices with clinically relevant applications.


Funding

  • European Union under Horizon 2020 Marie Skłodowska-Curie Innovative Training Network (2021). Supports research and development of high-precision digital light project system for 3D printing of microfluidic chip and hydrogel-based organ on a chip devices.
  • Enterprise Ireland Commercialisation Fund (2021). Supports the development of microfluidic-based nanoparticle flow synthesis platform for formulation discovery and optimization of nanomedicine.


Research impact

Economic impact

Dr Zhang’s research addresses the gap in microfluidic manufacturing in Ireland’s medical device ecosystem. The microfluidics industry is predicted by Markets and Markets to have a market value of $58.8 billion by 2026. Ireland has significant microfluidic R&D activity, including DCU’s Fraunhofer Project Centre, the University of Limerick’s Stokes Institute, and several leading companies, including Cellix, Biosensia, PolyPico, Radisens, Novus Diagnostics and Remedybio.

However, these companies all focus on applications of existing microfluidic devices: there is an acute lack of microfluidic manufacturing expertise in Ireland. In particular, no company in Ireland has an entire process chain to move from prototyping to mass production of customised microfluidic devices. The toolkit established by Dr Zhang’s team at UCD fills this gap. His team engage with companies on the various steps in the process of developing microfluidic chips for specific purposes, reducing the risk of scale-up failure, saving costs and accelerating product development. Currently, the team has worked with eight partners from industry and research organisation, and developed more than eight microfluidic chips for diagnostics or drug synthesis.


Health impact

Diagnostic devices that reply on microfluidic chips improve patient outcomes and save lives. Dr Zhang’s team are helping bring these devices to the market, and hence to patients, much faster than would otherwise be the case, therefore contributing to public health.

To give a specific example, Dr Zhang as his colleagues have been working with an Irish start-up, Novus Diagnostics, to develop microfluidic devices that diagnose sepsis, the body’s life-threatening immune response to infection, which can cause organ failure within hours. Developing diagnostics like these usually takes two to three years, with a high risk of failure. Dr Zhang’s team could reduce this to less than one year. Patients will thus have access to this technology much quicker.

They are also working on microfluidic devices to develop nanoparticles for gene therapy. This will make it faster to develop new therapies and will accelerate the treatment of many genetic diseases, like the skin disorder epidermolysis bullosa, as well as the development of mRNA vaccines.


Academic and technological impact

Precision moulding is used to mass manufacture low-cost plastic microfluidics. These moulds are critical for forming the necessary tiny channels. Dr Zhang has developed unique self-lubricating moulds that increase mould life 5-fold and reduce moulding defects, thereby increasing efficiency and reducing waste. This new technology is patented and licenced by a UCD start-up.

Dr Zhang is recognised internationally as a leader in this area, as evidenced by having twice chaired the international conference on Polymer Replication at Nanoscale, and having been elected as a Board Member of the Microfluidics Association, working on several standards and white papers for microfluidic devices, which will help the industry as whole to make chips better and faster. Dr Zhang is Associate Editor of the open access journal “Frontiers in Lab on a Chip Technologies”. Three PhD students from his team received Best Paper Awards at leading conferences on the novel development of micro mould technology.


Selected media


Selected academic references

  • Zhang N., Zhang, H.G. and Fang, F.Z., Improved electrodeposition, 2020 (International Patent Application Number: PCT/EP2021/063881)
  • Cong, H., & Zhang, N. (2022). Perspectives in translating microfluidic devices from laboratory prototyping into scale-up production. Biomicrofluidics, 16(2), https://doi.org/10.1063/5.0079045
  • Guan, T., Zhang, H., Fang, F., & Zhang, N. (2022). Synthesis of two-dimensional WS2/nickel nanocomposites via electroforming for high-performance micro/nano mould tools. Surface and Coatings Technology, https://doi.org/10.1016/j.surfcoat.2022.128351
  • Zhang, H., Guan, T., Zhang, N. and Fang, F., 2021. Fabrication of permanent self-lubricating 2D material-reinforced nickel mould tools using electroforming. International Journal of Machine Tools and Manufacture, 170, https://doi.org/10.1016/j.ijmachtools.2021.103802
  • Guan, T., Sineenat, Y, Cong, HJ., Douglas, C., & Zhang, N. 2022. Permanent Hydrophobic Surface Treatment Combined with Solvent Vapour Assisted Thermal Bonding for Mass Production of Cyclic Olefin Copolymer Microfluidic Chips, ACS Omega, 7(23), https://doi.org/10.1021/acsomega.2c01948
  • Jagannath, A., Cong, H., Hassan, J., Gonzalez, G., Gilchrist, M. D., & Zhang, N. 2022. Pathogen detection on microfluidic platforms: Recent advances, challenges, and prospects. Biosensors and Bioelectronics: X, https://doi.org/10.1016/j.biosx.2022.100134