Patent Protection

Microfluidic devices offer automation and high-throughput screening, and operate at low volumes of consumables. Although microfluidics has the potential to reduce turnaround times and costs for analytical devices, particularly in medical, veterinary, and environmental sciences, this enabling technology has had limited diffusion into consumer products. Their efficient commercialization has implications for biomedical sciences, veterinary medicine, environmental monitoring and industrial applications. In particular, market diffusion of microfluidic laboratory and point-of-care diagnostic devices can contribute to the improvement of global health. In their commercialization, consultancy and patent protection are essential elements that complement academic publishing. Additionally, the awareness of patent law can enable researchers to pursue patent protection efficiently. Our research is directed to the analysis of microfluidics market, identification of issues, and evaluation of commercialization strategies. We also study patent law in the US, EU, Japan and internationally. Understanding of the patent law allows obtaining optimized, valid and valuable patents, while accelerating implementation to market route. Understanding of commercialization strategies and patent law will benefit not only the inventors, industrial partners and investors but will also increase the economic growth and social impact of microfluidics.

Mobile Medical Applications

Mobile medical apps have the potential to revolutionise healthcare systems around the world. They will influence the healthcare systems globally – empowering patients and clinicians, and potentially reducing healthcare burden worldwide. Mobile medical apps are expanding rapidly and they hold a potential to transform the patient-healthcare provider relationship through saving time and reducing costs. Commercial examples include health management applications, bedside monitors, heart rate monitors and point-of-care diagnostics. However, the effectiveness of the regulatory agencies will be crucial in overseeing this process. In 2013, the U.S. Food and Drug Administration (FDA) released its guidelines on the regulations of mobile medical apps.  Although strategies to regulate these mobile medical applications are clear, their effect on the quality of healthcare delivery and patient safety has not been investigated thoroughly. For example, they may malfunction or their unintended use may harm patients. As the public continues to embrace mobile apps for the management of their healthcare, the providers must act in accordance with the regulations to ensure patient safety. We assess the implications of the mobile medical applications on healthcare systems and evaluate their regulatory oversight from various perspectives: patients, clinicians, entrepreneurs, academics and researchers. We also work with the Cabinet Office of the United Kingdom to support policy making in healthcare.

Publications

1. Yetisen, A.K., Volpatti L.R., Coskun, A.F., Cho, S., Kamrani, E., Butt, H., Khademhosseini, A., Yun, S.H. Entrepreneurship. Lab-on-a-Chip. 15 (18), 3638-3660 (2015) link

2. Yetisen, A.K., Volpatti, L.R. Patent Protection and Licensing in Microfluidics. Lab Chip, 14 (13), 2217-2225 (2014) * Lab on a Chip Top 10% link

3. Volpatti, L.R., Yetisen, A.K. Commercialization of Microfluidic Devices. Trends in Biotechnology (Cell Press), 32, 7, 347-350 (2014) link

4. Yetisen, A.K., Martinez-Hurtado, J.L., Vasconcellos, F.C., Simsekler, M.C.E., Akram, M.S., C.R., Lowe. The regulation of mobile medical applications. Lab Chip, 14 (5), 833-840 (2014) link