Developing Optimized Aerosol Drug Delivery Systems
Aerosol-based pulmonary-delivered drug devices offer significant value by enabling targeted drug delivery directly to the respiratory system, enhancing treatment efficacy while minimizing systemic side...
View Article5 Drug Delivery Solutions for Cell and Gene Therapy (CGT) Challenge
Cell and Gene Therapies (CGT) are revolutionizing modern medicine by offering potential cures for previously untreatable diseases. However, the effective delivery of these advanced therapies poses...
View ArticleImpact of New FDA Laboratory Developed Tests Policy
The U.S. Food and Drug Administration (FDA) made a significant update to its regulatory approach for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). Detailed in a FDA...
View ArticleCombination Product Regulation Basics
What is a combination product and why is this important from a regulatory perspective? The simple answer is that a combination product is a product which comprises of two or more items which are...
View Article5 Regulatory Considerations For Developing a Combination Device
A combination product is a product which comprises of two or more items which are covered by different regulations, for example a pharmaceutical and a medical device. As they are covered by two...
View ArticlePowerful Business Presentations: Tips for Visual Impact and Common Mistakes...
Crafting powerful business presentation materials requires a subtle balance between visual appeal and clearly written content. While it is essential to focus on the overarching theme, it is often the...
View ArticleHow Minimum Viable Products Deliver the Most Valuable Products (MVP) for...
A good starting point to achieve more accurate budgeting in medical device development is to clearly define the intent of the Minimum Viable Product (MVP). By establishing a clear vision of the MVP...
View ArticleHow Continuous Integration Improves Medical Device Firmware
Originally a practice at only the very largest software houses — the likes of Google and Amazon — continuous integration (CI) has worked its way into most major projects these days. It has become a...
View Article5 Key Features of FDA Draft Guidance for Predetermined Change Control Plans...
Implications for Medical Device Manufacturers On August 22, 2024, the U.S. Food and Drug Administration (FDA) released a draft guidance document for industry and FDA staff on ‘Predetermined Change...
View ArticleRoot Cause Analysis for Medical Device Development
Part of medical device development, or any product development for that matter, is understanding when things go wrong. What corrective actions or mitigations should we take to ensure that we have...
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