Postpartum hemorrhage (PPH) remains a significant global health concern as the leading cause of maternal mortality worldwide. According to the World Health Organization (WHO), each year, about 14 million women experience PPH resulting in about 70,000 maternal deaths...
Exploring the Assay Development Pipeline for In-Vitro Diagnostics (IVDs)
Establishing a Strong Assay Foundation Before we can conceptualize IVD product configurations, we must establish assay inputs which include, but are not limited to: Identify the need for the test, e.g. diagnose breast cancer or sepsis, identify bacteria, monitor...
5 Keys to Successful Partnerships: Building Stronger Collaborations to Support Medtech and Pharma
Successful business partnerships within the life sciences industry are often the cornerstone of thriving drug development. Here are five essential keys to forging successful partnerships that will support your pipeline and drive innovation.1. Communication: The...
Best Practices: Preparing for a Patent
Bob BouthillierDirector, Electrical Engineering, VeranexIn this post, our director of electrical engineering Bob Bouthillier covers the importance of writing a patent for your product, and the kind of research you can do prior to and while working with a patent...
Common Costs in Preclinical Testing Programs
All preclinical study estimates are not created equal and they can get expensive. Medical device innovators need to know what goes into the making of a high-quality, value-based preclinical study and have an understanding of the value that high-quality preclinical...
Identification, Engagement and Commitment of Key Players for a Successful Preclinical Study
Assembling a team for an efficient preclinical studyWhen it comes to kicking off your preclinical study, assembling the right team will help you anticipate challenges and implement solutions that will help your study progress efficiently, saving you time and...
Scope of Statistical Applications in Risk-Based Quality Management (RBQM)
Risk-based quality management (RBQM) represents a core area of clinical development that systematically focuses on both safety and data quality risks across the clinical trial lifecycle and is increasingly expected by regulatory agencies. The European Commission...
How to Design an Efficient Preclinical Testing Study
A medical device's pathway from concept to commercialization can be fraught with pitfalls, setbacks, and a need to recurring, significant investments. Our preclinical teams are often asked by prospective sponsors for in-vivo preclinical studies that are premature....
What is Fast to Proof-of-Concept?
We see a continued need from our clients, both large and small, to partner with organizations that can deliver meaningful and actionable solutions focusing on usability, design, and engineering in phase 0 through phase 2 front-end engagements. That’s why we offer a...
Leveraging AI and ML in Medical Products – Part 3
Bob Bouthillier Director, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence (AI) and machine learning (ML) today, its potential across a variety of applications, an analysis of challenges faced by...