Root 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...
View Article5 Key Features of FDA Draft Guidance for Predetermined Change Control Plans...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for Medical Device Manufacturers On August 22, 2024, the U.S. Food and Drug Administration (FDA) released a draft guidance document for industry and FDA staff on ‘Predetermined Change...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 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 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 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 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 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 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 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 ArticleDeveloping 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 ArticleChoosing a Drug Delivery System Imaging Technology
Accurate and precise delivery of pharmaceuticals or therapies often depends on real-time imaging systems. These imaging techniques enhance both accuracy and precision; however, the choice of imaging...
View ArticleEmerging Medical Devices for Animals
A Look Beyond the Cone The cone of shame, or more formally known as the Elizabethan collar, is probably the device that comes to mind when most people think of medical devices for animals. A plastic...
View ArticleMedical Device Development Initiatives to Curate Community and Innovation
Project Pods and Returning to Office At StarFish, we design medical devices and embrace the energy and shared passion that comes when our team members get to work together in person. Technology and...
View ArticlePeer Kudos Reflect Company Culture and Values
The importance of peer recognition cannot be underestimated. From the very early days of StarFish, employees have given Kudos to their peers at monthly all hands meetings. This blog is a selection of...
View ArticleHow Elearning and LMS Empower Medical Device Employees
At StarFish Medical, we embody a culture of learning and ongoing improvement to comply with medical device regulations, improve efficiency and deliver continuous innovation and risk mitigation. Since...
View ArticleSharing and Using SuperPowers and Kryptonite
Four years ago, StarFishers embarked on a SuperPowers journey to foster a culture where people are inspired and able to do the most fulfilling work of their lives and learn how to use them to be their...
View ArticleValidating Filter Integrity for Biopharmaceutical Manufacturing
Alternatives for Assessing Filter Integrity Biopharmaceuticals are highly complex and regulated products. Single-use (SU) sterilizing grade filters are used to ensure that everything entering the...
View ArticleFDA Guidance on using ISO 10993-1
Insights on Risk Management for Biocompatibility Evaluation Biocompatibility evaluation is a critical component of ensuring the effectiveness and safety of medical devices. The FDA Guidance on Using...
View ArticleService Design in Medical Device Development
Designing for the Biggest Picture Service design ensures that elements of the entire user experience are considered. From a medical device perspective, it starts from the moment a device is created to...
View ArticleTips for “Voice of the Customer” Medical Device Research in Low- and...
Voice of the Customer (VoC) research is an integral component in the user-centric design and development of medical devices. It is increasingly an expectation of regulatory bodies to ensure devices...
View Article
![[-100%] Commodity Intelligence – (Android Apps)](http://play-lh.googleusercontent.com/j67-qJvmnn4xnVlYVZ9ZhtZUJIgwjKekJGoKQT6D1KHcWGZxtQaFroummEvwV17na7tyh1pGbbeWCRdWtTKqeg=w950-h950)
