The number of StarFish Medical YouTube subscribers grew by 32% in 2023 and social media views increased an amazing 100%. This round-up features the 10 most viewed Medical Device videos that we created in 2023.
Our 2023 top 10 medical device commercialization videos cover a variety of medical device commercialization topics ranging from Prototyping Proof of Concepts, Writing Medical Device Manufacturing SOPs, and Optics Tolerancing Simulation, to Managing Changing Regulatory Environments, and International Women’s Day.
- Prototyping Medical Device Proof of Concept
Throughout the development of a medical device product there are technology-related project risks that have the potential to negatively impact budget and timeline. In this video, Kenneth MacCallum explains how the development process defines medical device proof-of-concept (POC) prototypes to mitigate these risks, either by resolving the uncertainty one way or the other, or by testing the use of a new or different technology.
- Designing High Performance Project Teams
Program Manager, Leila Kheradpir, shares her tips for designing high performing medical device project teams at StarFish Medical. She describes the techniques and philosophies she uses to help teams gel and collaborate internally.
- Optical Tolerancing Simulation for Medical Devices
Ryan Field explains the importance of tolerancing in designing an optical medical device and discusses methods of tolerancing simulation. Tolerancing in the optical design process reduces costs by focusing on the parameters that are going to be most critical for optical performance. In an optical system millimeter or even sub-michrometer differences can be significant to optical performance. It’s important to understand what imperfections can be tolerated and within what ranges.
- International Women’s Day – What does “Embrace Equity” mean to you?
The aim of the IWD 2023 #EmbraceEquity campaign theme is to get the world talking about Why equal opportunities aren’t enough. People start from different places, so true inclusion and belonging require equitable action. This video features 12 StarFish Medical employees sharing what “Embrace Equity” means to them. Happy International Women’s Day.
- Writing Medical Device Manufacturing SOPs
Alexandra Reid, QA/RA Specialist at StarFish Medical, shares her top tips for writing medical device manufacturing SOPs (Standard Operating Procedures). These written instructions help detail routine activities, repetitive tasks, and are a recommendation and a requirement from regulatory bodies such as ISO 13485 and the FDA. Sandy has written a full white paper on SOPs for manufacturing for medical devices available on the StarFish website.
- Cell and Gene Therapy Manufacturing Innovation
Gary Skarja. BioServices program manager at StarFish Medical, explains why manufacturing equipment innovation are critical to the realization of life changing products in the emerging cell and gene therapy sector. Over the last decade, cutting edge cell and gene therapies have been developed to treat, or even cure, a range of debilitating conditions including cancer, neurodegenerative diseases and infectious diseases.
While the therapeutic potential for these products seem almost limitless, the adoption of the global health care systems is severely restricted by high costs and limited availability. Gary shares why this is the case.
- Tips to Navigate Changing Medical Device Regulatory Environment
Dhruvitha Krishna, QA/RA Specialist at StarFish Medical, shares three tips and themes she has observed companies use to successfully navigate the introduction of the new EU MDR regulations, when businesses found themselves in a situation where they had to pivot and transition to a new quality management system and remediate a lot of their product files. Dhruvitha’s tips can be applied to the ever-changing medical device regulatory environment.
- Optical Medical Device Prototyping vs Design for Manufacture
Ryan Field talks about the differences between design for Optical Medical Device Prototyping and design for Optical Medical Device Manufacturing. Both are important parts of Optical Medical Devices design, but smart engineers focus on issues and goals unique to each phase of development. Learn the function of each phase and tips for ensuring you are working on the right problems at the right time.
- Map Supply Chain Strategies to Commercialization Phase
Vanessa Faria, Supply Chain Manager for StarFish Medical, maps supply chain strategies to each commercialization phase of medical device development. Medical Device Development phases discussed include proof of concept phase, transfer to manufacturing and commercialization. Vanessa also discusses redesigning the entire supply chain in order to align with business strategy and vision of the product.
- Creating SBOMs for Medical Devices
John Turner, StarFish Medical Software Manager, explains the importance of SBOMs (Software Bill of Material) and the FDA’s draft guidance from last year has a solution to that. Medical devices in a large hospital setting have potentially thousands or tens of thousands of software libraries exposed to new Cyber-attacks daily. The SBOM is a tool that allows you to quickly find vulnerabilities in the software you have.
Astero StarFish is the attributed author of StarFish Medical team blogs. We value teamwork and collaboration on all of our medical device development projects.