Introduction to this Workshop
Macroeconomic and regulatory aspects in the commercialization of new diagnostics products based on new technology trends are becoming more and more urgent topics in the invention and development of new products. Microfluidics, micro/nano biotechnologies, and single-molecule technologies (“Digital Biology”) have transformed research and the product landscape in the biomedical arena in the past few years.
The impact of these enabling technologies will make it essential to adapt current strategies to meet future demands. Most important is the alignment of device function & performance with its cost structure.
This workshop will bring attendees up-to-date on aspects of product development, commercialization, and cost structure in the conversion of cutting-edge technologies into commercial products.
Refreshments will be served at this workshop.
Topics Addressed at this Workshop
- Smart Consumables in Biomedical Device Markets
- Micro/Nano/Bio Technologies
- Single-Molecule Technologies
- Chip Technologies
- Integrated Cartridges
- Commercialization and Economy of Scale
- Economics for successful (Point-of-Care) in-vitro Diagnostics Products
- Automation and Manufacturing Technologies
- Adoption of new Technologies in biomedical Markets
Workshop Presenters and Presentation Details
John Zeis, CEO, Foundry Medical Innovations
Presentation Title: Manufacturing Considerations for Microfluidic Design
Presentation Summary: This presentation will cover the drivers behind design for manufacturing. Several factors influence design such as user requirements, where users are geographically located, cost targets, and material selection to name a few. Topics will include prioritizing these factors and move forward with implementing manufacturing processes into prototyping, different key obstacles along the way, and how to overcome these obstacles.
Sergey Shevkoplyas, Ph.D., Associate Professor, Biomedical Engineering, University of Houston
Presentation Title: Blood Microfluidics: Low-cost Diagnostics and High-throughput Separations
Presentation Summary: The integration of microfluidics with the biomedical sciences has fundamentally transformed the way we interact with living systems and address the pressing challenges facing human health and healthcare delivery today. Microfluidic devices and systems enable us to investigate vital physiological processes at their natural scale with unprecedented resolution, and in turn to use this new knowledge for developing novel devices with useful functionalities. In this talk I will describe our recent work towards development and commercialization of (i) a rapid, low-cost test for point-of-care diagnostics of sickle cell disease in resource-limited settings of sub-Saharan Africa, and (ii) high-throughput technology for separating blood into components and eliminating mediators of toxicity from stored blood during transfusion.
Marc Madou, Ph.D., Chancellor's Professor
Mechanical & Aerospace Engineering and Biomedical Engineering, University of California-Irvine
Presentation Title: Merging Electrical and Centripetal Forces with an Enzyme Cascade on a Compact Disc for the Ultimate in Analytical Performance in Molecular Diagnostics
Presentation Summary: In this contribution we introduce the merging of three platform technologies to achieve optimal lower limits of detection at a low cost for point of care molecular diagnostics. The first platform technology entails inexpensive Carbon-MEMS based Interdigitated Electrode Arrays (IDEAs) that achieve a redox amplification factor of more than 30. Detection limits of attomols are within reach with this technology. The 3D carbon IDEAs are fabricated by first nano-imprinting 3D patterns on a polymer precursor followed by pyrolysis of the polymer in an inert atmosphere. The second platform technology is based on specific DNA detection using an enzymatic cascade of a set of kinetically well-balanced enzymes: DNA polymerase, ATP sulfurylase, flavin adenine dinucleotide (FAD) synthetase and an apo-enzyme (apo-glucose oxidase). PPi generated by isothermal DNA amplification is converted into ATP by the ATP sulfurylase that is used by the FAD synthetase to produce FAD. FAD diffuses to an enzymatic electrode where apo-glucose oxidase has been entrapped in a hydrogel. Apo-glucose oxidase is a glucose oxidase without its prosthetic factor FAD. In the presence of FAD produced by the cascade, the reconstituted glucose oxidase, produces thousand of electron per second in presence of glucose. The third platform is the CD microfluidic platform, that not only automates and multiplexes the enzyme cascade assay but further increases the lower limit of detection because of the flow of the analyte over the redox amplifying electrodes. In the case demonstrated a reciprocating system fluidic system on the CD, using a micro-balloon system, allows for flow measurements at relatively low rpm and with very small amounts of sample.
Jurg Bartholdi, Manager Diagnostics, Invetech, Inc.
Presentation Title: What Do Product Developers Need to Know—Advice from the Field
Presentation Summary: Development of laboratory systems presents a range of challenges at every stage from initial concept and design through to launch. This session will provide field-proven strategies to address the risks and roadblock in the product development process in order to improve the chances of commercial success. Real-world insights will be provided on how to balance market needs with quality, performance and costs factors.