Welcome to our blog, your go-to resource for the latest insights and trends in the life sciences industry.
Our blog is designed to provide expert guidance, practical tips, and thought leadership on key areas like medical device development, digital health, and clinical trial optimization. We cover a wide range of topics, including decentralized clinical trials (DCTs), the integration of digital health technologies (DHTs) in DCTs, and the use of Platform as a Service (PaaS) in medical device software development, to help you navigate the complex intersection of innovation and regulation. Our goal is to keep you informed and equipped with the knowledge needed to overcome industry challenges, drive innovation, and succeed in the rapidly advancing life sciences sector. Explore our blog for in-depth insights and the latest developments, and feel free to reach out if you need further assistance.
Categories:
- Clinical Research
- Cybersecurity & privacy
- Data Integrity
- Device Validation & Usability
- Digital Health
- Digital Health Technologies
- Digital health Technology
- Digital Transformation
- General
- Innovation
- Logistics
- Medical Device Software Development
- Quality Management
- Regulatory
- Risk-Based Quality Management
- Usability
- Usability Testing
- Validation
Fit-for-Purpose or Bust: A Real-World Rubric for DHT Verification, Validation & Usability
What makes a DHT truly “fit-for-purpose” in a clinical trial context?
How do verification and validation differ—and why does it matter?
What role does usability play in maintaining data integrity?
How can sponsors implement a risk-based approach to DHT qualification?
Which real-world lessons show how validation failures can derail trials?
When a Digital Health Tool Becomes a Medical Device: The Hidden Regulatory Roles No One Told You About
If your digital health tool is already collecting endpoint data, are you absolutely sure regulators don’t see it as a medical device?
Who’s carrying the legal liability for your connected device right now—the manufacturer, the sponsor, or… you?
When your next trial audit lands, will your documentation prove compliance—or just prove confusion?
How confident are you that your “wellness app” wouldn’t trigger MDR or FDA oversight if used tomorrow in a global study?
While others are quietly securing their regulatory status, are you still assuming “we’re not a medical device company”?