Program ArchitectureMedical device commercialization projects often require the Project or Program Manager to also wear the hat  of “Program Architect.” 

“When it is obvious that the goals cannot be reached, don’t adjust the goals, adjust the action steps.” Confucius
What’s your product vision? And what is the mission that you will undertake to get there? These are the big questions that program and project managers concern themselves with throughout commercialization projects.  This is also precisely where the art of program architecture comes into play.  Much like a Systems Architect puts together building blocks to meet the technical goals of the product, Program Architects assemble building blocks to meet the strategic goals of the product.

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medical devices in Regenerative MedicineI recently spoke with Michael May, President and Chief Executive Officer of CCRM, a Canadian not-for-profit that develops technologies and launches new companies by supporting both academic and industry activities in the field of regenerative medicine, including cell and gene therapy. Our conversation focused on the intersection of medical devices in Regenerative Medicine.

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Health Canada’s Action Plan on Medical Devices
In early 2019 Health Canada released more specifics of their Action Plan on Medical Devices. The Action Plan is intended to reinforce Health Canada’s commitment to ensuring that Canadians have access to safe and effective medical devices based upon the most up to date information. It has a three-prong strategy involving:
i) improve regulatory rigor for medical device path to market,
ii) strengthen post-marketing monitoring and follow-up, and
iii) increase transparency to the public.

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Agile in medical device developmentWhile every inventor wants his/her product to reach the market first, it is not often an easy task. The technical capabilities required are many in number and the unknowns are greater.
This is even truer for medical device first-time entrepreneurs who have a prototype and are maneuvering through processes, FDA requirements, certifications and mass manufacturing know-hows. A medical device almost always is a combination of hardware, firmware and software, forming the essential components of the product.

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Low Power Embedded Design

(c) Can Stock Photo / viperagp

The demand for medical devices that must do more with less power is continually increasing.  So, what kind of tricks can we designers resort to in order to keep up with increasingly stringent power requirements? As usual, creativity and good judgement play a key role in successful designs.
Here are 10 tips to help improve the power efficiency of your ultra low power embedded designs.

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EMC TestingElectromagnetic Compatibility (EMC) testing is a key part of device development for medical or other devices. It consists of two different sets of tests: Emissions testing, and immunity testing. As you might guess from the name, emissions testing looks at the electromagnetic emissions from the device under test (DUT), while immunity testing looks at what happens to the DUT when it’s subjected to electromagnetic emissions from an outside source.

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adoptive cell transfer therapy
50 years of research in stem cell biology, immunology, molecular biology, genomics, engineering and advanced materials, are transforming the therapeutic landscape much like antibiotics once did for infectious diseases.  Regenerative Medicine (RM) and advanced therapeutic products encompass a very diverse and broad range of approaches that enable the body to repair, replace, restore and regenerate damaged or diseased cells, tissues and organs.

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Regenerative Medicine Medical Device DesignI suggest that Regenerative Medicine will be associated with a parallel revolution in medicine- much like introduction of the world wide web and the internet in the ’90s caused a revolution in global communications and information technologies.  As with all revolutions, history records that there are those that can thrive, adapt and ride the tides of change, and those that do not.  I prefer to ride the wave.

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