ISO17025, GLP and ViVitro Labs; GM Gerry Wight from our New Clean Room; Record Sales; Co-Founder, David Walker; TCT 2013; New Faces; Latest Research Citations.
VNews - Cardiovascular Device Testing News, brought to you by ViVitro Labs

Gerry's soundbite

Gerry Wight, ViVitro Labs GM, gives a sneak peek at our new clean room, talks about his first months on the job and previews what's ahead from ViVitro Labs.


ViVitro Pulse Duplicator

ISO 17025 vs GLP Clarification for in vitro testing

Guided by the ISO 5840 standard and FDA guidance document, ViVitro Laboratory Services is an ISO 17025 accredited laboratory. 

Our new white paper clarifies the benefits that ViVitro Labs’ ISO 17025 accreditation offers to our clients and explains how ISO 17025 and GLP (Good Laboratory Practices) relate to our testing services.


ViVitro Testing Equipment

Updated list of Cited Publications

ViVitro Labs products are cited in hundreds of peer reviewed publications.

Our online list is now updated with scores of new citations.  

Please contact us if you would like to add your publication to our list.


We welcome your comments and invite you to contribute items for inclusion in future issues of VNews.  


Meet the team!


Our team has grown! 
 With all the new faces at ViVitro Labs, we thought we'd take a team picture and put faces behind the e-mails and phone conversations from recent months.  Left to right: Joe McMahen, Ted Hodson, Gerry Wight, Dev Amatya, Rob Fraser, Janet Murray, and Lori Woodman.  Visit our contact page for phone and email details.

TCT 2013 News: Record Sales; New Clean Room Services, Products and Leadership

TCT 2013 was a resounding success!
  ViVitro Labs announced a 150% increase in sales year to date over 2012, expanded cardiovascular device clean room testing services, new products and new company leadership at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

Record revenues from global demand confirm the continued popularity of the world’s first and most widely used heart model since 1984.   The ViVitro Pulse Duplicator enables hydrodynamic testing to determine valve performance and acts as a physiological heart model to generate peripheral flows.  View Company Overview Video.

Launched on November 1, 2013, a Class 100,000 Clean Room at ViVitro Labs in Victoria B.C. has capabilities up to class 10,000 and is part of a range of expanded facilities for laboratory and product customization.   Jason Dolynny, Director of Manufacturing: “The clean room allows a wider range of testing services. In addition to testing services, we can deliver custom prototypes requiring a clean room manufacturing environment and meet requests for higher volume medical disposables.”  View Lab Overview Video.

Gerry Wight is the General Manager of ViVitro Labs.  Bringing 30 years’ experience at technology companies in a variety of different customer facing roles to ViVitro Labs, Gerry’s first area of focus is customer service and satisfaction. Gerry Wight’s previous roles include General Manager of an RFID medical tracking product company, Vice President of Sales and Marketing for a radio manufacturer and Sales, Marketing and Product Management roles with well-known telecom manufacturers. Gerry is on the Board of Directors of the Victoria Advanced Technology Council

“Since joining ViVitro Labs in September, I’ve been impressed with the caliber of our customers and their commitment to ViVitro Labs products and staff.  I’ve had the pleasure of meeting many clients in person or by phone.  And I enjoyed getting to know many more at TCT 2013.”

Dr. Dev Amatya
Dr. Dev Amatya is responsible for continued expertise of particle image velocimetry flow visualization.  Involved in research publications of in vitro simulations of physiological diseased states, Dr. Amatya is an active technical committee member (Cardiovascular Implants and extracorporeal systems) in the Standard Council of Canada (Canadian participation in ISO and IEC).

Dr. Amatya brings over 10 years of experience in the cardiovascular device community, receiving his PhD from the Department of Biomedical Engineering at the University of Minnesota.  His expertise lies in conducting hydrodynamic and flow visualization testing of tissue engineered and polymeric heart valve substitutes.  He has conducted post-doctorate research with a cardiac surgeon assessing the performance and clinical outcomes of left ventricular assist devices,  worked with an interventional radiologist on the development of a novel flexible catheter intended to deliver stents to higher cerebral vasculature, and performed research and product development work at Cook Medical.

Rob Fraser
Rob Fraser is responsible for lab operations including testing adherence with ViVitro Labs’ ISO 17025 Quality Management System. He specializes in hydrodynamic and durability testing of prosthetic heart valves and other various cardiovascular devices. Mr. Fraser earned his M.Sc. Mechanical Engineering, Queen’s University, and B.Sc. Mechanical Biomedical Engineering Coop, University of Alberta.  

His academic projects include: Reducing the Effects of MRI Acoustic Noise Using Noise-Evoked Activity in the Auditory Cortex as a Measure and Glaucoma Drainage Device (working with Ophthalmologists to design a novel implantable medical device). Since joining the ViVitro Labs testing team in February 2013, improvements include a 250% increase in lab durability testing capacity, 50% more lab staff and implementing project scheduling using StarFish Medical QMS.  Results are higher on-time delivery, better satisfaction, and faster turnaround

Our products were featured in two presentations: The Thubrikar TAVR System presented by Dr. Mano Thubrikar and Tendyne overview: Transapical Mitral Valve Replace presented by Mark Reisman.  We met many customers and a post-show survey indicates booth visitors received the information they were seeking. 

15 Minutes with David Walker

David WalkerDavid Walker, co-founder of Vivitro Systems with Larry Scotten, stopped by recently to catch up and meet new employees—including Dev Amatya, a former client and now our Senior Research Biomedical Engineer. He graciously agreed to return and bring readers up to speed on his current activities and adventures.

Dev Amatya and David Walker
Dev Amatya and David Walker
Life after Vivitro Systems: Since selling the business I have a new mode of operation. I still go into the office every day, but I spend most of my time on research and a dwindling amount on the busyness of business.

Current Research Focus: I’m working on a simple computer model of the left heart system with a view to simulating the performance of the Vivitro laboratory model. I would like to assess the performance of heart valves under conditions that are difficult to create and perhaps impossible to measure in the physical model. The nice part is I don’t get my hands wet with test fluid!

How’s it going: I’m taking a more measured approach, with the plan to write a book. It's nice for me that “publish or perish” is no longer a consideration. I am rapidly, it seems, approaching three score and 10 years. It would be nice to complete the project soon but, “the best laid plans of mice and men .....”!  Its an enjoyable time but different. I miss the “buzz” of business and interacting with customers. I don't miss deadlines and the filling of forms.

Thoughts on the industry: I try to follow what’s going on in the industry. My interest is piqued by the progress of people and companies I’ve known over the years.

Thoughts on ViVitro Labs: Very pleased with what has happened. The last newsletter caught my eye regarding recent sales. I think Scott has done a great job of taking the ball and running with it.  Excellent and getting better!   

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