ViVitro News


Spring 2017 cardiovascular device testing news is now online

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cardiovascular device testing news

The Spring 2017 Vnews is now online.  Vnews is your source for cardiovascular device testing news.  In this issue:

  • Dr. Kassem Ashe and Duane Cronin
  • Comfort Medical new Japanese sales agent
  • FAQ: Bellows for HiCycle, FAQ Mount devices
  • ProtomedLabs offers EU training
  • New! PIV Load Assembly
  • $1500 Day in our Lab
  • Research citations since January

ViVitro Labs signs Comfort Medical as Japanese sales agent

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Japanese sales agent will increase visibility and service for ViVitro Products

(VICTORIA, Canada and Saitama, Japan) March 26, 2017— ViVitro Labs Inc. and Comfort Medical, Inc. announced today their agreement to expand ViVitro Labs product distribution in Japan through an exclusive product distribution agreement.

The products include the ViVitro SuperPump, ViVitro Pulse Duplicator, ViVitro HiCycle Durability tester and ViVitro Endovascular Simulator. Services include Durability, Pulsatile-Flow, and Steady Flow Laboratory Testing and equipment repairs and calibration conducted by ViVitro Labs.

Gerry Wight, ViVitro Labs General Manager notes: “After meeting with Comfort Medical President & CEO, Toshiharu Miyake in Victoria last August, it was clear his past experience and robust network, including AHS Japan, Baxter, Edwards Lifesciences and Mitsubishi, were ideal for promoting and supporting the professional cardiovascular research and testing products and services developed and manufactured by ViVitro Labs”.

Comfort Medical President & CEO, Toshiharu Miyake, confirms the natural fit of the two companies: “Our mission is to deliver best-in-class medical products to Japanese customers with utmost passion and integrity. ViVitro produces the top cardiovascular device testing equipment in the world. They are regularly cited in the latest cardiovascular device research.  They are an excellent choice for Japan’s world class device manufacturers and top universities and research institutions”.

Gerry Wight, ViVitro Labs General Manager and Comfort Medical President & CEO, Toshiharu Miyake

Research conducted by Comfort Medical indicates a growing need by medical device manufacturers in the cardiovascular space, Academic and research institutions, and Biomedical engineering schools, require the higher quality and reliability offered by ViVitro Labs combined with professional Japanese language support and service afforded by Comfort Medical.

About Comfort Medical
Comfort Medical, Inc. is a distributor of medical device and lab instruments, Wound healing equipment (Rigenera, Human Brain Wave, Italy), Animal lab testing instruments, Cardiovascular and anesthesiology products, and IT related products and services. Founded in 2008 by President & CEO, Toshiharu Miyake, the company mission is to deliver best-in-class medical products to Japanese customers with utmost passion and integrity. The company is based in Saitama, Japan

TEL/ FAX +81-48-873-3299
Mobil +81-90-6515-1751

About ViVitro Labs
ViVitro Labs Inc. offers industry-leading cardiovascular test equipment and related laboratory testing and consulting services. Hundreds of organizations in over 40 countries for over 30 years have trusted ViVitro expertise, accuracy, and quality for their heart valve, LVAD, TAH, stent, and graft testing. ViVitro Laboratory Services holds ISO/IEC 17025 accreditation based on ISO 5840. ViVitro products are manufactured by StarFish Medical. ViVitro’s A2LA Scope of Accreditation includes the physical and mechanical testing of heart valve substitutes.

For more information please contact:
Mike Camplin
250.388.3531 x210
# # #


ViVitro Labs at Medtec Europe: Win a DAY IN OUR LAB!

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ViVitro Labs at Medtec Europe

ViVitro Labs at Medtec Europe will highlight the ViViFlow Electromagnetic Flow Meter and ViVitro Labs Endovascular Simulator for cardiovascular devices in booth 3E41, Hall 3 from 4-6 April in Stuttgart Germany.


Cardiovascular Pioneers: Creating aortic heart valves from autologous pericardium

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Dr. Kassem Ashe and Duane Cronin

Team uses equipment leasing to stretch funds

Dr. Kassem Ashe (KA), Cardiovascular Surgeon at St. Mary’s General Hospital in Kitchener, Ontario, Canada, and Duane Cronin (DC), Professor of Mechanical and Mechatronics Engineering at University of Waterloo, recently leased a ViVitro Pulse Duplicator for early design work in their Autologous Pericardial Tissue valve project. ViVitro Lab Manager Rob Fraser (RA) spoke with them recently about the project, their experience leasing the equipment, and future plans.

RF: Please tell us about the work you are doing.

DC: We’re looking at a version of an aortic heart valve that can be created from autologous pericardium.  Our goals were to understand the effects of changes in dimension on the functionality and performance of the valve, and ultimately to optimize the geometry of the valve.

KA: In terms of background, the limitations of using biological aortic valves with respect to durability are well known. The issues relate to early calcification, accessibility, and cost. We have seen early failures in patients–in non high risk patients, meaning no renal failure, no calcium drugs for osteoporosis, not a young patient– and we have to explant these valves because they have failed.

We are looking to solve this issue with autologous pericardium. To date most attempts to use autologous pericardium have been to reconstruct the valve free hand, (Duran, Osaki). Autologous pericardium is much more durable and resists calcification when compared with bovine or porcine pericardium. Despite the anti-calcification modalities developed and used today there still is a propensity to early calcification in many subgroups, namely the young patient, renal failure. We are also looking at an ideal valve design. The idea is that a valve could be fashioned as soon as the patient’s chest was opened and before the patient was put on pump.  We started off with something that was going to be created by hand (stentless) and we moved to a valve that is stented with design features that potentially are superior to existing valves on the market. We are at the stage of fine tuning our computer modelling with the aim of creating a prototype that we can mold or 3D print and then have something that can be easily put in by the majority of surgeons.

We’re utilizing both experimental and computational methods to understand the challenges and functionality of these valves in order to optimize them. We’re taking a new and different approach in terms of construction and materials in order to address the well-known challenges, including calcification and durability, which exist today.

RF: Calcification is certainly an issue everyone is looking to resolve. How is the work going?

KA: We leased the pulse duplicator back in August and we had a number of technical difficulties, not so much in the case of the Pulse Duplicator—it worked perfectly.  We had some initial ideas in terms of the concept of the valve we were going to use and then we had some difficulty implementing it and getting consistent numbers. We were implanting a free hand sewn valve into a Valsalva graft. The issue related to significant leakage through multiple needle holes that significantly affected closing volume. Towards the end of our two month rental with ViVitro, we were able to generate a number of great results that at least matched or could be superior to existing valves in terms of hemodynamics.  We’re at the stage of completing the computational model that Duane is working on, and then, hopefully, we will revise the design further and get some more funding so we can take it further.

DC: We’ve been working in experimental and computational modelling for many years and found that the fusion of those two areas has enabled us to answer a lot of challenging questions. We know that for something as critical as a heart valve, we can’t just live in the computational world. There has to be some real physical testing and prototypes to understand what’s going on in order to use and even to validate these models. However, as a starting point the models can give us some insight into the effective geometric variations, without material and other variabilities that may creep into experimental testing. Each aspect of this initial phase of work had a benefit in terms of the modelling giving us really good insights into the physics, what we wanted to achieve and how we could choose an optimization path. And then on the physical side, being able to actually test the valves themselves in a realistic condition and understand how these effects were supplemented by real world aspects as well.

RF: What challenges have you faced with this project?

KA: We spent a considerable amount of time getting ethics approval to use human tissue.  Unlike using porcine and bovine tissue that are readily available and don’t need the same hurdles, we had to get ethics approval to use live human pericardium. We now have ethics approval to test our various designs.

RF: What is next for this project?

DC: There are still many technical challenges to solve in this space. We think we’re on the right path moving forward. We have good potential for success by identifying what are the critical areas. Without focusing on the other valves that are out there today, we know that there are some good valves and some that are having some challenges and have a solid plan to address those challenges.

ViVitro has been very understanding and helpful in terms of allowing us to achieve some very significant goals in a very, very short period of time– which was the intent of our initial funding. Our goal now is to secure additional funding to continue our studies.

KA: What started off as research project, has now expanded on to something entrepreneurial.

Because of some of the travels I’ve done, I have seen firsthand that the developing world requires an ideal tissue valve. If you look at the world at large, there is an incredible population that requires these valves because rheumatic heart disease and congenital valvular disease continue to be endemic in these third world countries.  These people need a valve that doesn’t require any anti-coagulation because they are going back into their tribes or communities, and due to the distance, follow-up is limited. The practice has been primarily to put in the tissue valve of choice, the people go back into their community and they are lost to follow up. Unfortunately, they go on to early valve failure from calcification.

Another problem with tissue valves is shortage of heart valves in certain sizes. That’s because emerging markets have created such a demand that we’re seeing these shortages. So there is need to have an alternative material with potentially better durability.

RF:  You mentioned the lack of available valve sizes.  Is this the smaller sizes that don’t fit the North American population norms?

KA:  Surprisingly, it’s primarily the most popular sizes, the 23-25 mm size valves are very hard to get now. We’re back ordered because we’re using them so much.  We have the same problem with grafts. Having said that, when the market leader is having problems meeting the expanding market demands (primarily it’s the Asian market), companies that are not the market leaders are now seeing this incredible window to come in.  Unfortunately, I think that some of the valve designs that exist with these other competitors may not be ideal. Without mentioning names, there’s a company that we’ve implanted a significant number of valves that we are seeing coming back today.  I am also old enough to remember the Ionescu Shiley valve and early failure, because of a design flaw. Today’s generation of tissue valves are not ideal.  I think the very fact that when I open up the ViVitro website and you are advertising a device/methodology to measure calcification extent and location to effect design speaks to the fact that there have been hundreds of millions of dollars invested to look at anti-calcification methods and to date nobody has solved that problem yet. We believe with autologous pericardium and looking at a different type of design that can be fashioned quickly and with the engineering expertise that Duane brings to the table, hopefully we will be able to fill that void.

RF:  Any advice for readers?

KA: Persistence and get a great team partner like Duane.  Collaborate and persistence.  And when you fail, collaborate and continue persisting.

DC: Our rule of thumb is: “Experimental testing always takes longer than you plan for”. It’s just the nature of experimentation. I’ve been doing it for a number of years and it’s always that way. Take a nice progressive and step-wise approach to development. Start with something you know and then evolve or gradually evolve towards your intended design.  I think that’s a classical experimental mechanical approach that always serves well in these complex environments like a heart valve.

RF: I was laughing to myself when you said that experiments always take longer than you think.

DC: I always tell my graduate students to use the rule of Pi.  If you budget 2 hours, multiple it by Pi and that’s how long it will take you. I used to say 3-4X, but engineers always believe a formula if there is Pi in it.

ProtomedLabs SASU now offers EU training for Pulse Duplicator and SuperPump

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(Victoria, Canada and Marseille, France) 17 February 2017- ViVitro Labs Inc. and ProtomedLabs SASU today announced ProtomedLabs SASU successfully completed their first EU training session on the ViVitro Labs Pulse Duplicator and is now available to conduct Pulse Duplicator and SuperPump installation and training for European customers on behalf of ViVitro Labs.

“We were pleased to welcome 2 graduate students from KOCE University in Sanyer/İstanbul, Turkey for a 2 days training in Marseille,” said Karim Mouneimne, President & CEO of ProtomedLabs SASU. “Our VP of Engineering, Vincent GARITEY, covered all the important topics to allow our customers to walk out of the training with the required skills for the Pulse Duplicator operation. Our customers were delighted and extremely pleased with the training.”

“It was really a great experience at Protomed Labs in Aix-Marseille University. I really enjoyed learning about hydrodynamic testing requirements, ViVitro Pulse Duplicator, its calibration, flow testing, heart valve testing, and at the same time  practicing,” noted Mrs. KOSE in a recent post for Cardiovascular Mechanics.


Mrs Banu KÖSE (Right), and Mrs Ece TUTSAK (Left).

Mrs Banu KÖSE (Right), and Mrs Ece TUTSAK (Left) with Vincent GARITEY

Gerry Wight, General Manager of ViVitro Labs confirms, “Offering training conducted by ProtomedLabs is a natural progress in our plan to provide increased customer service to EU clients. Based upon the positive feedback from trainees, ProtomedLabs is now ready to conduct Pulse Duplicator and SuperPump installation and training for our European customers on behalf of ViVitro Labs.  I believe this will increase our market presence and quality of support in the region.”

Visit ViVitro Labs and ProtomedLabs at Medtec Europe

ViVitro will be exhibiting in stand 3E41 and ProtomedLabs will be exhibiting in stand 3B40 at Medtec Europe, one of the leading B2B trade shows for medical devices and components in Europe, from April 4-6 2017 in Stuttgart, Germany.

About ViVitro Labs

ViVitro Labs Inc., Canada, offers industry-leading cardiovascular test equipment and related laboratory testing and consulting services. Hundreds of organizations in over 39 countries for 30 years have trusted ViVitro expertise, accuracy, and quality for their heart valve, LVAD, TAH, stent, and graft testing. ViVitro Laboratory Services holds ISO/IEC 17025 accreditation based on ISO 5840. ViVitro products are manufactured by StarFish Medical in Victoria, Canada.

About ProtomedLabs

ProtomedLabs SASU, France, is an ISO 13485 single source company. We offer responsive turnkey engineering solutions in device testing for companies developing implantable and interventional cardiovascular devices.  We provide equipment solutions and services to help device manufacturers meet the highest standards in the industry.

For more information please contact:

ViVitro Labs Inc.

Mike Camplin

Director of Marketing

+1.250.388.3531 x210



Président & CEO

+33 4 86 68 68 10

In vitro testing in the age of transcatheter therapies

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By Rob Fraser

Advances in medical imaging modalities have allowed health care providers to offer a wide range of minimally invasive interventions which are implanted via catheters. Patients benefit tremendously from the minimally invasive nature of these options, which have caused an explosion of new devices to come under development. Patients are now demanding transcatheter approaches (albeit in the authors opinion perhaps too prematurely) which is putting pressure on traditional treatments. Like most disruptive technologies many peripheral industries are impacted when a new way of doing things becomes the norm. At ViVitro we specialize in conducting in vitro testing for a wide range of cardiovascular devices, and these advances in medical imaging have had a profound impact on our industry as well.

20 years ago if you wanted information on how a new cardiovascular device would perform, your main source of data would be in vitro testing, however now medical device companies are able to gain insights about their device from animal models that were not possible only a few decades ago. As a result, there is a new generation of device developers who have done much of their development purely in animal models. Ethical concerns aside, there are benefits to an animal focused approach since many devices require native anatomy that is challenging to re-create in a bench top setting. There are numerous reasons why there will always be a place for in vitro testing, but ones I find often overlooked are:

Durability Testing

Cardiovascular devices are typically placed around a beating heart or in a pulsatile flow environment. As a result cyclic loading is always applied to these devices creating the risk of a potential failure mechanism. Computational models can be useful in designing for fatigue but before a device is ever implanted in a patient, it must go through physical life cycle testing. The fastest way to get these results is to accelerate them in a laboratory setting, something impossible to do with animals. At ViVitro we are able to put a device through millions of cycles in a single day, something that would take almost a month in an animal.

Many clients have durability testing on their long list of things to accomplish before they call their design “finished” but my observation is that this is often left until too late in the design process. Clients will come with what they feel is a finalized design and are simply looking to check the durability box on their device submission only to find too late that they have a serious design flaw. At ViVitro we understand the motives behind this, durability tests can be lengthy and are perceived as expensive undertakings. For that reason we offer a range of service options to make it possible for companies to put prototypes through their paces early in the design process, preventing costly surprises when the finish line looks to be in sight.

Controlled Environment

As mentioned earlier animal testing has huge benefits including being able to test numerous different aspects of a device with a single animal. In addition to device hydrodynamic performance, data on biocompatibility, hemolysis, migration, etc can be examined at one time. While this is extremely useful, and cost effective for start-ups, it can also be very frustrating when things go wrong. If a problem is identified, the root cause ascertained, a solution implemented often the most conclusive way of determining if a device iteration will be a success is to conduct a controlled in vitro test. With the exception of mandatory testing requirements to validate a design for regulatory approval, many clients come to us looking to test a specific change in their device design.

In doing so many people familiar with animal models will approach a single test in the same multifaceted way their approach an animal study. The beauty of bench top testing is to simplify the problem down to a set of variables which can be controlled or altered in an exacting manner. At ViVitro our equipment makes this task a breeze, and we often create customization for clients interested in testing a unique aspect of their design. We also have a history of creating test protocols used in numerous different cardiac devices

In summary, advances in medical imaging have created a new generation of transcatheter medical devices. These devices revolutionize treatment for patients and are causing disruptions in many industries including ours. The imaging advances allow designers gain huge insights from animal models, which were previously the sole domain of bench top testing. For those clients new to in vitro testing I would recommend:

1) Test early – Contact an in vitro service or equipment vendor early in the design process to understand how they can help at all stages of your design. This will accelerate your design process and prevent costly late stage design stages

2) Simplify – Bench top testing allows designers to simplify a complex system down a bare minim of components to understand individual aspects of a device design. At ViVitro we are experts at justifying the simplifications necessary to test different aspects of a device design.

Rob Fraser, Msc., is a Standards Council of Canada (SCC) Member to ISO/TC 150/SC 2 – Cardiovascular implants and extracorporeal systems (ISO 5840) committee. ViVitro’s Lab Manager, Rob is one of only two Canadian members on the committee.

New! DAY IN OUR LAB Cardiovascular Device Testing Option

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VICTORIA, British Columbia, January 31, 2017 – ViVitro Labs, a global leader in cardiovascular device testing, announces DAY IN OUR LAB, a cost-effective way to quickly utilize calibrated ViVitro equipment in a professional lab setting with access to world class expertise in cardiovascular device testing.

DAY IN OUR LAB gives access to ViVitro equipment and the use of one lab tech for an entire day in Victoria, Canada. This low-cost option gives immediate access to ViVitro expertise and equipment. Accelerate your development and decrease your time to market. Options include data collection and/or analysis, high speed video, consultations on technical, quality or regulatory affairs. Clients can engage as many times as they like in this manner.

– Preparation of an agenda before visit.
– Holder or device fixturing materials, need details to prepare ahead of visit.
– Access to one piece of equipment during their visit.
– Visit supported by ViVitro trained professional staff member to maximize time with the equipment.
– Unlimited High-speed Video.

ViVitro Labs testing expertise covers a wide range of cardiovascular devices. Our testing products help answer unique design-specific questions as well as perform verification and validation testing. In addition to purchase, our equipment is also available through other lower cost shorter term options including leasing, ViVitro-conducted feasibility, and regulatory testing.

About ViVitro Labs
ViVitro Labs Inc. offers industry-leading cardiovascular test equipment and related laboratory testing and consulting services. Hundreds of organizations in over 40 countries for over 30 years have trusted ViVitro expertise, accuracy, and quality for their heart valve, LVAD, TAH, stent, and graft testing. ViVitro Laboratory Services holds ISO/IEC 17025 accreditation based on ISO 5840. ViVitro products are manufactured by StarFish Medical. ViVitro’s A2LA Scope of Accreditation includes the physical and mechanical testing of heart valve substitutes.

For more information please contact:
Mike Camplin
250.388.3531 x210

VNews Winter 2017 issue now online

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Winter 2017 VNews
The VNews Winter 2017 issue is now online. Published triannually, VNews is your source for cardiovascular device testing news. Issue highlights include:

  • Dr. Rouzbeh Amini on Experimental techniques and tricuspid valves
  • Shining Sun discusses Chinese cardiovascular device market
  • Impact of FDA Program Alignment
  • New $1500 Day in our Lab option
  • How to confirm your flow meter is working properly
  • Using Pulse Duplicator for Right Heart Testing

INTERVIEW: Yuewei (Shining) Sun discusses Chinese cardiovascular device market

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Yuewei (Shining) Sun

Yuewei (Shining) Sun


Yuewei (Shining) Sun is the manager at Fortis Hi-Tech, ViVitro’s sales representative in China.  Sun visited ViVitro in early January for a week of extensive training.  During a break, he talked with ViVitro Labs (VL) about the unique attributes of the Chinese market, Fortis-Tech, and plans for the future.

VL: Tell us about your background and what you do at Fortis Hi-Tech:

YS: After graduating from university with a degree in mechanical engineering, I worked in automation – hydraulics and pneumatics of the motor.  After a few years in this field I switched to fluid transmission – especially for automobiles. Specifically a sealant and adhesive dispenser system.

Our main business at Fortis is service and engineering. We have six employees and two assist me with hardware support for ViVitro equipment.  Prior to working with ViVitro we were looking at areas to expand beyond automotive applications because the area is quite competitive in China and it is very hard to be unique. We wanted to have a new company to do creative things. A friend in the medical device industry suggested we consider medical equipment because it is growing very fast in China. I researched the equipment market, and while studying stents, I noticed heart valve products and learned about ViVitro.

My friend said that ViVitro is a very good company and there were customers in China that I could contact for more information.  I spoke with them and they were very interested in ViVitro products. I contacted David Mester (ViVitro GM at the time) about selling products in China. Fortunately, David agreed I could be the distributor in China. When I visited the team in Victoria, I knew I had made a good decision.

Five years later, under Gerry Wight’s management, ViVitro communicates a lot more, holds a seminar in China every year and visits our customers at least once a year with me.

VL: What was it like to sell cardiovascular device test equipment in China five years ago?

YS: Five years ago there were only 2-3 manufacturers in China and the testing center was still using an old standard.  The manufacturers were studying and trying to find a new supplier, not just for the testing equipment but for the testing methodology. Initially I would simply supply equipment, translate information provided by ViVitro, and transfer it to customers because I had no background in cardiovascular testing.

In the beginning this worked because the ISO standards that applied in China were minimal compared to today, so companies didn’t need further service or consulting. Even today, the ISO standards used are not the latest available. While the industry still lags behind North America and Europe, they require much more information than five years ago.

VL: Do you plan to expand into cardiovascular testing services?

YS: We are currently working with customers to build system parts. I want to expand the Fortis business by making simple custom equipment (small accessories compared to the ViVitro equipment) for universities and institutes.  For example, a steady flow device that provides an overview of the flow, but not specific measurements.  It would be suitable for teaching and early research and development, but not for regulatory purposes.


VL: What’s unique about the Chinese market?

YS: For me there are two differences. When we started working with cardiovascular devices, we got our knowledge from US and Canada.  In the beginning, we didn’t develop, we just followed.  Now, more and more investors are investing in China because it is big.  We can do more independent research with data from China for devices made for Chinese people.  In the beginning, the difference was that we were not a developer, but a follower.

The second difference is the construction of the patient.  We have a different heart disease focus in China.  We have a very big market for one kind of product that is smaller in the US. In the US, heart valves are mainly for elderly patients.  In China, because there are patient differences or the treatments are different, more younger people need heart valve surgery.  They have different requirements for these kinds of devices.

Traditional Chinese medicine uses needles and other physical treatments to keep the body balanced long term.  For a big disease, western medicine works right away, but it doesn’t care about afterwards or about long term– things like maybe you should adjust your body to be as far as possible from displaying visible signs of disease.  Chinese medicine cares about keeping all of your organs balanced together. Not, if you liver is diseased, you just work on the liver.  No, we want all of the organs and all of the body to work together.

If you have a very serious disease in China, they normally have two ways; one is to use western medicine to control the disease because it really works, and at the same time they take Chinese medicine to adapt the whole body for the long term suitability against the disease. We normally use both ways.  But we think the western medicine is so strong it may cause other problems you cannot see.  Chinese medicine is more subtle and can cure your disease very peacefully.

VL: Does it work? Have they done any tests?

YS: No. Chinese medicine is hard to prove.  We use different plants as natural medicine which have poison inside.  We cannot prove that this is totally suitable for a specific disease or is not harmful to the body.  Even now, these medicines are only available in China and Asia. We believe the treatment is better although it is a little hard to prove. Lots of work remains to prove the results in a way similar to western testing.

VL: What are the opportunities and challenges for cardiovascular devices in China?

YS: The market is growing very, very fast in China.  Initially, only a big company would be interested in cardiovascular devices, but now more and more mid-sized companies are becoming involved.  The market is not as interested in the equipment itself, but in the chance to obtain more details for their testing or the design they are developing. That means the basics are fine now, but they seek more professional equipment, accessories, service and consulting.  That’s our opportunity and our challenge. The opportunity is they ask for more.  The challenge is that Fortis should know more.  That’s why I’m here for more information to satisfy our customers.  Fortunately, the Chinese market is quite new to this area, ViVitro is the leader, and I can get the top training from ViVitro experts. Together we grow to serve our clients.  I look forward to continuing my personal training so I can better serve my customers in China.

VL: Is the market mainly about the domestic market or creating devices for other countries?

YS: Since last year, the big manufacturers in China have begun to acquire foreign companies and develop the global market. Microport is an example. Previously they focused on the market in China. Now they try to meet standards and marks for CE in order to export to Europe or other countries.

VL: Any advice for cardiovascular researchers in China?

YS: For me the main problem is time. The market is changing very fast.  If you have a good idea, you should act very fast to follow the changing market.  If not, you’ll lose the opportunity. Universities and institutes are trying to do more research in China.  In the future we will conduct Chinese research and testing so we can use all of the data from China. We are conducting research now and I hope that soon we will make devices just for China.


ViVitro Analysis: Impact of FDA Program Alignment

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By Vesna Janic, Director, ViVitro Labs QA/RA

The FDA reorganization announced a while ago seems to be finally shaping up this year.  The main goal of the Program Alignment is to better coordinate field inspections with product reviews from FDA research centers and to identify companies that need more frequent inspections based on the poor state of their quality.  In today’s global market, and due to limited FDA resources, the hope is that more risk-based inspection planning and collaboration with foreign agencies will eliminate duplicate inspections and make compliant manufacturers’ lives a bit easier through less frequent visits as a reward for exceeding QMS requirements and running high quality operations.

Logistically, under the Program Alignment plan the 5 regional Offices of Regulatory Affairs (ORA) will be dissolved and replaced with commodity-based and vertically integrated inspection programs for drugs, biologics, medical devices, tobacco products, food and bioresearch monitoring that will operate from 20 FDA district offices. Commodity-based teams will have specialized investigators with technical expertise and adequate training in their field of expertise.  For medical device companies, this means they will be inspected by investigators who are not only  specialized in medical devices with in-depth knowledge of Quality System Regulation (QSR) and the intricacies of manufacturing devices, but the investigators will also have a sub- specialty in their particular product.  This will have huge impact on the quality of an FDA inspection compared to the previous practice where a company could be inspected by an investigator with a background in food, tobacco or pharmaceutical products.

As with any change, the question remains if the FDA will be less effective initially while figuring out how to align 5000 FDA investigators into different review programs while developing new inspection protocols. 2017 may be tough for both the agency and inspected facilities, however my belief is that all manufacturers in good standing with the agency will benefit from less frequent inspections and will enjoy working with investigators that are specialized in their commodity. This new approach should positively impact product quality and patient safety.