Glen Farrell

Five Steps to Medical Device Development Success

Medical Device Development SuccessIn my experience, a product’s best chance at successful commercialization is to ensure it follows a Five Step Development process. Company value, and user safety will rely on the due diligence required within each step of the process. The engineers who develop these frameworks live and breathe Murphy’s epigram, “Anything that can go wrong will go wrong”. Your investors and customers will thank you.

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Nigel Syrotuck

How to Conduct Particulate Pre-Testing for ISO 18562-2:2017

Pre-Testing for ISO 18562-2:2017Recently we conducted pre-testing (testing done in-house to increase confidence before undertaking more expensive formal testing) for ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter is an ISO standard for particulate testing in breathing gas pathways. This is a sub-standard of the larger ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process standard. In this blog I will share our approach from my engineering perspective.

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Hannah Rusak-Gillrie

The Effect of Formative Test Fidelity

Why it’s important to simulate realistic use for medical devices

The degree to which users, environment, and test articles are realistically simulated for a medical device formative test has a significant impact on the integrity and quality of the usability study data. Spending the time and effort to meet the recommended level of fidelity helps ensure that data collected from the formative test will be impactful and valuable to the design team.

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Kevin Meric

Algorithm Aided Design – Personal Data Driven Medical Device Design

Algorithm Aided Design Personal data driven design is here. With Algorithm Aided Design (AAD) and the ability to adjust your design with rules, mathematics equations and parameters, a custom design is fast to produce and send to a 3D printer. The medical market presents lots of opportunities in that direction. For example, a start-up has developed 3D printed eyewear based on the 3D scan of a face.

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Azra Rajwani

Pros and Cons of Virtual Audits

Onsite or Virtual AuditsOver the last year and a half, so many things have changed. We’ve had to adopt new practices to ensure the safety and wellbeing of not only ourselves, but also our friends, family and the general public.
Aside from working from home, one big change for medical device manufacturers is in auditing. We’ve completely shifted from onsite audits to virtual audits, with many certification bodies offering virtual audits as an option moving forward even with the economy re-opening.

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Tara Lysechko

Update on Health Canada Activities and Changes

Health Canada Regulatory Development UpdateKeeping current with Health Canada’s medical device regulatory developments

Over the course of the last year and a half, the number of accomplishments that Health Canada has achieved both in urgent response to the COVID-19 pandemic and towards priority projects is impressive.
It has been said that timing is everything. While the operational pressures from COVID-19 affected proposed timelines and milestones for regulatory framework innovation, the pandemic also provided an opportunity to test temporary agile regulatory measures.
These measures provided an important proof of concept for ideas that were already under consideration and reinforced the need for regulatory agility to support timely access to needed health products. The lessons learned from the regulatory response to the pandemic will therefore form an integral part of Health Canada’s future regulatory innovation efforts.

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Arash Samimi

Why Medical Device Startups Should Listen to The Ecosystem

A Three-Pronged Strategy to Stay Ahead

Listening Strategy for Startups
A medical device is a convergence point where various technologies and regulations come together to impact patient health. Within the diverse ecosystem of the medical device industry, there are fluctuations driven by new entrants, new technologies and new markets. These forces create market shifts and open up opportunities. KPMG has published an interesting whitepaper on the subject.

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