This review highlights how designing Autonomous Clinical Chemistry Assay diagnostic products with kinetic read outs helps mitigate challenges with interference that are especially relevant in point of care diagnostics (POCD). Topics covered include Kinetic Assay Versus Endpoint Assay, Point of Care, Hook Effect, Clinical Laboratories Standards Institute, and real time laboratory diagnostics.
2020 highlighted the importance of rapid diagnostics. Many companies approached us in 2020 looking to develop a better COVID-19 diagnostic test. No matter what the technology, state of development or size of the company, we have found that the key differentiator between a successful medical device product and an unsuccessful one, was having a good, […]
3 compelling reasons to pursue a Bio Services career in medical devices 2020 highlighted the need for Biotech in medical devices and shone a light on potential careers in this field. The global CoVID-19 pandemic developed and grew over 2020 from the initial focus on traditional medical device development to rapid development and manufacture of […]
What is a coronavirus and why a CoVID-19 Point of Care Diagnostic is so important The virus that causes CoViD19 is a coronavirus. The viruses are so called because the virus physically looks like a crown (‘corona’ derived from ancient Greek word for crown) when imaged by electron microscopy. These coronaviruses are a group of […]
Biological sciences medical device breakthroughs for this decade have a solid base to build upon. 3D tissue printing, advancements in cell therapy and regenerative medicine and gene editing breakthroughs were developed and adopted in the last decade. Developing these technologies into commercial products and practical medical devices will be the work of the 2020 decade. […]
Dr. Katherine Elvira recently spoke with Nick Allan about her work developing lab-on-a-chip (microfluidic) technologies to investigate how drugs enter human cells and to analyze how they perform when given to patients. Dr. Elvira is the Canada Research Chair in New Materials and Techniques for Health Applications and an Assistant Professor in the Department of Chemistry at […]
The internet is full of great research data. This blog shows how to research four questions one should address when considering Infectious Disease Diagnostics market potential by using public information. I explain how publicly posted research and reports can help analyse and build answers for activities like developing a new PoC Assay.
I suggest that Regenerative Medicine will be associated with a parallel revolution in medicine- much like introduction of the world wide web and the internet in the ’90s caused a revolution in global communications and information technologies. As with all revolutions, history records that there are those that can thrive, adapt and ride the tides […]
Dr. Stephanie Willerth is the Acting Director of the Biomedical Engineering program and the Centre for Biomedical Research at the University of Victoria, and Member of the International Collaboration on Repair Discoveries (ICORD). We spoke recently about her current research in Regenerative Medicine and collaborations with StarFish Medical.
What Yeast, Richard Nixon, a CIA agent, a Teenager, Donald Trump and $9 billion dollars have to do with a Fake Medical Device Bad Blood: Secrets and Lies in a Silicon Valley Startup was at the top of my 2018 summer fun reading list. It was released in May 2018 and written by John Carreyrou (the two […]
For insight into Infectious diseases Point of Care (POC) assay industry trends I’ve summarized several leading sources for trends including the World Health Organization, the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting key topics, and an Ipsos Mori poll published by the Bill and Melinda Gates Foundation.
A project manager’s tale of thinking creatively inside the box In the highly regulated field (as it should be) of medical device design and manufacture, sometimes the best way to secure regulatory approval needs more than thinking outside the box. It requires the project manager to build a different box.