StarFish Medical Blog: get the latest medical device innovation news

May 1

Ryan Field in Eastern Region, Engineering, Product Development | No comments

Laser Speckle Contrast Imaging: Visualize Invisible Fluid Flows

How to build a breadboard proof-of-concept system

It’s advantageous, when possible, for medical techniques to be non-invasive and inexpensive. One method of imaging flow (of blood and other optically scattering media) that meets these criteria is Laser Speckle Contrast Imaging (LSCI).

Apr 1

Kathryne Young in Business, Manufacturing, Product Development | No comments

Five Supply Chain Tips for COVID-19

The world of Supply Chain management changed in the first quarter of 2020. As the coronavirus spreads, and more and more people are affected by COVID-19, supply chains around the world continue to be heavily impacted. This blog shares five supply chain tips for COVID-19.

Apr 1

Nick Allan in Biotech | No comments

Why a CoVID-19 Point of Care Diagnostic will help insure our future

What is a coronavirus and why a CoVID-19 Point of Care Diagnostic is so important

Transmission Electron micrograph of a Coronavirus.

The virus that causes CoViD19 is a coronavirus. The viruses are so called because the virus physically looks like a crown (‘corona’ derived from ancient Greek word for crown) when imaged by electron microscopy. These coronaviruses are a group of enveloped single stranded RNA viruses which typically are responsible for the common cold. About seven kinds are known to cause an infection in humans. Four of these are seasonal and cause the common cold year after year after year. The remaining three coronaviruses are termed emergent coronaviruses because they have been the cause of outbreaks and epidemics.

Apr 1

Nigel Syrotuck in Business, Engineering, Regulatory | No comments

DIY COVID-19 Medical Devices

One response to possible COVID-19 medical device shortages is to try to hack DIY COVID-19 medical devices together. It’s very empowering to see open-source communities come together to try to turn out a workable design to help avoid dire shortages for those in need. However, development of medical devices is far more nuanced than it might seem.

Apr 1

Helen Simons in Regulatory | No comments

Health Canada improvements: Getting new devices to market

It’s always great to spend time with regulators to understand their point of view on the regulations and guidances they provide to us. It is also helpful to hear about the changes going on at Health Canada to gain insight into their roadmap for the future.

Apr 1

Alexandra Reid in Business, Product Development, Regulatory | 1 comment

How Regulators are addressing COVID-19 related Medical Device approvals

This blog gives a snapshot of what the FDA, Health Canada and the European Commission have put in place to fast-track COVID-19 related Medical Device approvals and provide quicker access to medical devices that deal with the COVID-19 outbreak.

Apr 1

Hannah Rusak-Gillrie in Industrial Design | 2 comments

Adjusting Human Factors Processes for COVID-19: Remote Creativity

©duiwoy55

New COVID-19 measures to protect our safety limit some human factors usability studies from being executed through traditional in-person facilitation. This blog identifies creative ‘COVID-19 friendly’ solutions to combat logistical hurdles for human factors research and evaluation activities supporting medical device product development.

Mar 3

Alexandra Reid in Regulatory, Uncategorized, Western Region | No comments

FDA Guidance on Non-Clinical Bench Performance Testing Information

Your Roadmap for Premarket Submissions

Are you wondering how best to organize your test plans and reports to make them submission ready? Look no further. The FDA provides a roadmap to follow for your premarket submission in their new guidance, ‘Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions’.

Mar 2

Brian King in Engineering | No comments

Using Monte Carlo Simulation for Biomedical Device Design

Light from biomedical devices interacts with human tissue, which contains a variety of structures and cell sizes and shapes. In many cases, optical scattering plays a strong role in the propagation of optical radiation. One common approach to simulating scattering is the Monte Carlo technique. Popular optics-simulation software incorporates Monte Carlo scattering, allowing you to circumvent the need to create your own code. However, a custom implementation allows for greater control of the simulation – and will certainly sharpen your understanding of how the technique works.

Mar 2

Josh Coutts in Engineering, Product Development | No comments

Create better functional models from anatomical scans

More than just a pretty model

Medical scanning technology allows us to find and generate our own anatomical 3D models. But having an anatomical model made (usually in the form of a mesh file, STL or OBJ) from a medical scanning technique (CT or MRI), doesn’t necessarily translate into something that can be used for testing.

Mar 1

Dana Trousil in Engineering, Manufacturing, Product Development, Regulatory | No comments

Clean or Sterile medical device: How clean does it need to be?

Medical devices often come into contact with patients, and users. Sometimes repeatedly. Addressing patient and user contact is a critical aspect of medical device development. Biocompatibility is a significant aspect of contact, but what about sterility? And if a device does not need to be sterile, then how clean does it need to be?

Feb 4

Nick Allan in Biotech, Business, Engineering, Product Development, Western Region | No comments

5 biological sciences medical device breakthroughs for this decade

Biological sciences medical device breakthroughs for this decade have a solid base to build upon. 3D tissue printing, advancements in cell therapy and regenerative medicine and gene editing breakthroughs were developed and adopted in the last decade. Developing these technologies into commercial products and practical medical devices will be the work of the 2020 decade.

Here are my top 5 medical device breakthroughs that will be enabled by a partnership between biological sciences and engineering.

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Laser Speckle Contrast Imaging: Visualize Invisible Fluid Flows

How to build a breadboard proof-of-concept system

It’s advantageous, when possible, for medical techniques to be non-invasive and inexpensive. One method of imaging flow (of blood and other optically scattering media) that meets these criteria is Laser Speckle Contrast Imaging (LSCI).

Five Supply Chain Tips for COVID-19

The world of Supply Chain management changed in the first quarter of 2020. As the coronavirus spreads, and more and more people are affected by COVID-19, supply chains around the world continue to be heavily impacted. This blog shares five supply chain tips for COVID-19.

Why a CoVID-19 Point of Care Diagnostic will help insure our future

What is a coronavirus and why a CoVID-19 Point of Care Diagnostic is so important

DIY COVID-19 Medical Devices

Health Canada improvements: Getting new devices to market

It’s always great to spend time with regulators to understand their point of view on the regulations and guidances they provide to us. It is also helpful to hear about the changes going on at Health Canada to gain insight into their roadmap for the future.

How Regulators are addressing COVID-19 related Medical Device approvals

This blog gives a snapshot of what the FDA, Health Canada and the European Commission have put in place to fast-track COVID-19 related Medical Device approvals and provide quicker access to medical devices that deal with the COVID-19 outbreak.

Adjusting Human Factors Processes for COVID-19: Remote Creativity

FDA Guidance on Non-Clinical Bench Performance Testing Information

Your Roadmap for Premarket Submissions

Using Monte Carlo Simulation for Biomedical Device Design

Create better functional models from anatomical scans

Medical scanning technology allows us to find and generate our own anatomical 3D models. But having an anatomical model made (usually in the form of a mesh file, STL or OBJ) from a medical scanning technique (CT or MRI), doesn’t necessarily translate into something that can be used for testing.

Clean or Sterile medical device: How clean does it need to be?

5 biological sciences medical device breakthroughs for this decade

Here are my top 5 medical device breakthroughs that will be enabled by a partnership between biological sciences and engineering.

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