Insights

Diagnostics

Below is a collection of articles, resources and stories from the Invetech team and industry experts, sharing their knowledge, experiences and advice on product development and market trends.

Diagnostics

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Emergency Use Authorization: How IVD Developers Can Use the EUA to Address COVID-19

Watch our interview with Fran White of MDC Associates on using the EUA for COVID-19 testing to fast track approval, what’s required by the FDA and how to plan for an eventual 510(k).

Detecting Coronavirus at the Point of Care – In Search of Bold Breakthroughs

In the fight against the Coronavirus pandemic, rapid detection of the disease is key. POC diagnostics can rise to the challenge by providing accelerated time to result at the point of need.

Drivers for Utilizing Cloud Solutions in POCT Device Development

Leveraging cloud solutions for Point of Care (POC) devices can significantly reduce development time and instrument cost while adding more diagnostic capabilities.

11 Ways to Reduce POC Consumable Costs

In this article, Darryl Donovan shares 11 ways to lower materials and manufacturing costs and keep your product development program on track.

Essential Design Principles to Develop CLIA Waived Devices

Making a complex test easy for end users is an interesting challenge and diagnostic device manufacturers must embrace good design principles to get it done.

How Strategic Program Management Can Foster Innovation for IVD Companies

In an interview with MedCity News, Gerald Kent discusses how in vitro diagnostic (IVD) companies can foster innovation and create value through strategic program management.

Microfluidic Cartridge Development: Key Considerations for Point of Care Diagnostic Devices

Since cartridge design plays a key role in the successful development of a complete POCT system, it is important for the cartridge design to mature ahead of the instrument.

Evolving Healthcare Trends Call for a Different Product Development Approach

In an interview with MedCity News, Andreas Knaack discusses how environmental changes and evolving healthcare trends are impacting the way product development should be approached for startups and established companies alike.

How to Improve Cross-Team Collaboration and Communication

Best practices for establishing a communication framework for more effective cross-site and remote, cross-time zone, and cross-team collaboration.

Guide to Managing IVD Product Development Risk

A Strategic Program Management approach to instrument development helps ensure a positive project outcome, fosters innovation and improves product design.

Machine Learning Applications in Medical Devices

Despite current constraints, the clear productivity gains available from well-designed and targeted machine learning systems will drive innovation in medical device design.

Delivering Innovation Through Human-Centered Design

While innovation is a top priority for healthcare companies and IVD manufacturers, it continues to be a frustration for organizations in its execution.