Nick Allan

TPP: The secret to efficient diagnostic device design

efficient diagnostic device design2020 highlighted the importance of rapid diagnostics.  Many companies approached us in 2020 looking to develop a better COVID-19 diagnostic test.  No matter what the technology, state of development or size of the company, we have found that the key differentiator between a successful medical device product and an unsuccessful one, was having a good, well-defined Target Product Profile (TPP) going into the development cycle.

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Rade Gadzic

Quickly verify environmental stress cracking (ESC)

verify environmental stress cracking (ESC)The ability to quickly verify Environmental stress cracking (ESC) is important because it is one of the most common failure mechanisms in parts made of polymeric materials. Proper selection of polymers is crucial to the successful design, production and longevity of any product, but it is particularly vital to the purpose and usage of medical devices. In addition to standard mechanical and thermal properties, sensitivity to environmental stress cracking should be a major consideration, especially when dealing with polycarbonate.

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Nigel Syrotuck

RoHS 2 vs RoHS 3 impact on medical devices

Note: RoHS 3 is a colloquial term referring to Delegated Directive (EU) 2015/863, which is actually an amendment to RoHS 2 (Directive 2011/65/EU) rather than a standalone Directive. Though this terminology has become somewhat common (common enough to keep using the term here), it’s technically inaccurate. Originally published in April 2016, the article is updated on March 2, 2021 to include more details on the July 22, 2021 deadline. 

RohsRoHS 3 – The Trilogy is Complete

Are your medical devices RoHS compliant?

The Restriction of Hazardous Substances (RoHS) Directive has had a substantial and permanent effect on the materials that go into many of the electronic products we make.

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Virginia Anastassova

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

FDA 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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