Virginia Anastassova

How to benefit from FDA ASCA (Accreditation Scheme for Conformity Assessment) Pilot Program

FDAFDA launched their pilot  ASCA (Accreditation Scheme for Conformity Assessment) Program on September 25, 2020. The intent for the ASCA program is to utilize accredited third-party testing laboratories to assess premarket applicants’ declarations of conformity to consensus standards for safety, performance and biocompatibility. The final guidance outlining the accreditation scheme for the ASCA pilot program can be found here.

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Lorenzo Gutierrez

Beyond the hype: Medical Device Artificial Intelligence (AI)

This blog explores medical device artificial intelligence (AI) with an overview of  AI, medical applications and devices, the investment landscape, and medical device artificial intelligence regulatory implications.
The term artificial intelligence (AI) has been over marketed and abused.  For instance, a rice cooker with AI, a watch powered by AI, a restaurant ordering app with AI, an air-conditioning unit controlled by AI, a coffee maker run by AI, and more.  Practically any product that is controlled by a computer can be made “cool” by adding “AI” as a suffix.  In my opinion, most of the products on the market labeled as such are using the term as a marketing gimmick, and do not actually use AI.

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Ryan Field

Overview of Optical Technologies for Point of Care Medical Devices

Optical Technologies for Point of CareThis blog provides an overview of optical technologies for point of care (POC) medical devices that have been developed or show promise. Point-of-care (POC) testing is diagnostic testing conducted at or near the location where a patient is receiving medical care (away from a clinical laboratory).
POC diagnostic devices allow for rapid diagnoses immediately following the collection of samples from patients. This contrasts with how medical testing has historically been done, in which samples are sent away for testing and results are received several days later.

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Nick Allan

Biotech in medical device companies

Biotech in medical device companies3 compelling reasons to pursue a Bio Services career in medical devices

2020 highlighted the need for Biotech in medical devices and shone a light on potential careers in this field.  The global CoVID-19 pandemic developed and grew over 2020 from the initial focus on traditional medical device development to rapid development and manufacture of PPE and with later emphasis on rapid ventilator builds.  This led to a deficit in quality assurance and regulatory affairs professionals needed to support the glut of new regulatory approvals required to clear the back log of innovations and registrations in countries clamouring to review and register new emergency products coming on line.

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Tammy Dewar

Is there job growth potential?

job growth potential

Don’t underestimate the value of leadership development

Employers who question the value of training often ask “What if we train people and they leave?” As a leadership development facilitator and coach, I often respond, “What if you don’t train people and they stay?” I’ve spent literally thousands of dollars investing in my own development, and so it seems a no brainer for potential employees to check out the specific job growth potential as well as the overall growth opportunities offered by the organization they are joining.

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Kerri Keeler

6 important changes for job hunters during COVID

job hunters during COVIDThe job hunting landscape is always changing and over the past several years it has been increasingly challenging for candidates to find the right company. In response to the pandemic these trends have become more noticeable as we all learn to navigate the new and often remote workplace, see the impact of reduced work forces, and learn about the changing priorities for both the candidates and the employers.

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Astero StarFish

How an extended recruiting process benefits candidates

extended recruiting process benefits
Job hunting can be daunting. Many candidates would like to get the process over as quickly as possible. But, an extended recruiting process benefits candidates and companies.
This blog shares insights on the StarFish Medical hiring process from recent hires, Master Planner, Paulina Osuna and Senior Software Engineer, Russell Haley, our People and Culture Director, Pamela Potts, and the company founder, Scott Phillips.

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Nigel Syrotuck

The Forgotten Art of Tolerancing

TolerancingModern education seems to be leaving behind a crucial lesson: Tolerancing

After speaking recently with budding young engineering students, I was pleased to hear that many get consistent access to engineering technology in their high school and undergraduate programs. It’s fantastic that hands-on exposure to tools such as 3D printers are becoming more common. That is translating into the impressive quality of students we see apply every semester. However, despite all this hands-on experience, there is clearly one skill that these short-term design projects aren’t teaching: effective tolerancing.

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Astero StarFish

Our Top 10 medical device development videos in 2020

medical device development videosOur top 2020 medical device development videos include 6 new videos. They join favorites from previous years and cover subjects including 2020 updates, COVID implications for research and POC devices, optimizing founder value, manufacturing for NPI, IVD insights, and working at StarFish.

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Joshua Hayes

Battery safety for medical devices

Battery safety for medical devices
As medical devices and instruments become more portable and ultimately wireless, the need for a reliable power source has become a major design element.  The demand for ever smaller, higher density battery packs is growing as portable medical devices shrink in size and develop more ergonomic forms.  With all of the size, form, capacity and performance demands on batteries, designers cannot ignore battery safety for medical devices.   There have been hundreds of injuries, property damage, and even deaths caused by exploding battery packs and resulting fires.

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