Posts categorized as“Biotech”

Joris van der Heijden

A Guide to Lean and Agile Medical Device Product Development

The success of development programs in the medical device and equipment industry almost always relies on hitting technical milestones that coincide with internal or external fundraising efforts. Especially early in the program, it is critical to hit technical milestones in a cost-sensitive and timely manner. This will eventually determine if a program has legs or […]

Susan Bantroch

Assay Verification in POC Medical Devices

Interference Testing, Strategy, and Detection Case Study The importance of performing assay verification BEFORE incorporation into a medical device can not be overstated. Countless hours and dollars can be wasted designing the perfect device if the detection assay fails in the field. Successful Point-of-Care (POC) medical devices increasingly rely on new and innovative analyte detection […]

Nick Allan

Autonomous Clinical Chemistry Assay Design Considerations to Mitigate Interference

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.

Astero StarFish

The Future of BioManufacturing

Six BioManufacturing Trends to Watch in 2022 The COVID-19 pandemic shed a light on the strengths and shortcomings of the global biotech infrastructure in relation to pandemic readiness and general support of biotech innovation.

Stephanie Willerth

Three Reasons to Think Canada When Developing Regenerative Medicine, Microfluidic-Based assays, and Cell Therapy Applications 

Personalized medicine approaches can transform the field of biomanufacturing through the use of additive manufacturing technologies. Successful implementation of such processes requires an interdisciplinary effort with engineers, biologists, and clinicians working together to achieve success developing regenerative medicine, microfluidic-based assays, or cell therapy applications.

Joris van der Heijden

Developing a Diagnostic Product for Use Outside a Laboratory

The COVID-19 pandemic has increased diagnostic testing outside the confinement of the laboratory. The hope is to enable healthcare professionals to perform testing in places where it was previously unthinkable to sample patients and directly analyze test results. Such places now include your home, airports, or the workplace. These innovative solutions greatly reduce the time […]

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