Exhibit 2001
`Exhibit 2001
`
`

`

`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 1 of 17
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
`
`Biomedical Device Consultants &
`Laboratories of Colorado, LLC,
`
`Plaintiff,
`
`v.
`
`TA Instruments - Waters, LLC,
`
`Defendants.
`
`Civil File No. 0:17-cv-03403
`
`DECLARATION OF MICHAEL
`GIRARD IN SUPPORT OF MOTION
`FOR PRELIMINARY INJUNCTION
`
`I, Michael J. Girard, hereby declare and state as follows:
`
`1.
`
`I have been retained by Plaintiff Biomedical Device Consultants &
`
`Laboratories of Colorado, LLC ("BDC") to offer technical analysis and opinions
`
`regarding various issues relevant to this action, including infringement and validity of the
`
`Patents-in-Suit, U.S. Patent Nos. 8,584,538 ("the '538 Patent"), 8,627,708 ("the '708
`
`Patent"), 9,186,224 ("the '224 Patent"), 9,237,935 ("the '935 Patent") (collectively, the
`
`"Patents-in-Suit"). I have personal knowledge of the facts herein, and if called as a
`
`witness, I could and would testify competently thereto.
`
`2. My education includes a Bachelor of Science in Civil (Structural)
`
`Engineering from the University of Illinois, and a Master of Business Administration
`
`from the University of St. Thomas.
`
`3.
`
`I am currently the President ofmy own consulting firm, Girard Technical
`
`Services, Inc. My firm provides research and development, engineering, and technical
`
`management consulting services in the medical device industry.
`
`4816-6498-1075\5
`
`Water Techs. Corp. v. Biomedical Device Consultants & Labs
`IPR2018-00498
`Ex. 2001
`
`Page 1 of 24
`
`

`

`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 2 of 17
`
`4.
`
`I have thirty-seven years of experience in engineering, twenty-seven of
`
`which are in the medical device industry. I am a named inventor on 38 issued U.S.
`
`Patents with additional applications pending.
`
`5. My experience includes work with many cardiovascular devices and
`
`specifically includes 19 years of heart valve experience. I've worked for several medical
`
`device companies in the role of development and testing of both surgical and
`
`transcatheter delivered prosthetic heart valves. Testing of heart valves usually includes
`
`durability testing at accelerated rates with equipment like the systems produced by BDC
`
`and TA Instruments. Therefore, I am very familiar with durability test equipment and the
`
`requirements of such testing. My curriculum vitae is attached hereto as Exhibit A.
`
`A. Technology Overview
`
`6.
`
`This case concerns equipment used for durability or high cycle fatigue
`
`testing of heart valves. Before any medical device, such as a heart valve, is marketed it
`
`must meet certain regulatory standards. International bodies, such as the International
`
`Organization for Standardization ("ISO"), set certain standards, such as those for testing
`
`the durability of medical devices, including heart valves. The specific standards for heart
`
`valves are defined in ISO 5840.
`
`7.
`
`Prosthetic heart valves must be tested to ensure that they will function for
`
`the anticipated life of the patient by opening and closing the valve leaflets under flows
`
`and pressures that are present within the human vascular system. The normal human
`
`heart beats about 40 million times each year. The test requirements for evaluating
`
`prosthetic heart valves according to the standards require that the valves be able to
`
`2
`
`Page 2 of 24
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`

`

`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 3 of 17
`
`survive and function for hundreds of millions of cycles ( e.g., at least 5 years or 200
`
`million cycles). The valves must also be able operate over a specific range of opening
`
`and closing pressures that simulate physiological conditions, and therefore testing
`
`standards require that a specific pressure differential be generated across the valve when
`
`closed.
`
`8.
`
`Testing systems use a test fluid to mimic blood and pressurize the fluid to
`
`mimic the blood pressure in the human body. Testing requires fluid flow through the
`
`valve and creating a pressure differential across the test valve when closed at a certain
`
`minimum pressure for a certain length of the cycle. A "drive mechanism" such as a
`
`pump drives the test fluid into the test chamber in order to create the fluid flow and
`
`desired pressure conditions. In order to complete hundreds of millions of cycles in a
`
`commercially viable timeframe, durability testing is done on an "accelerated" basis. In
`
`other words, the speed of the cycles is faster than a normal human heartbeat ( a normal
`
`beat rate is 70 beats per minute - bpm). Using current technology at accelerated cycling
`
`of 800 bpm, testing takes approximately six months to simulate 200 million cycles.
`
`B. Problems in Prior Art Technology
`
`9.
`
`The Patents-in-Suit identify several problems with the prior art.
`
`10.
`
`Driving mechanisms in the prior art had limited control over closing rates
`
`and would often produce "pressure spikes" when the systems maintain pressure above the
`
`testing threshold for the amount of time required by testing standards. These pressure
`
`spikes are undesirable because they wear out valves during testing faster than they would
`
`be worn out in the human body, causing false test failures.
`
`3
`
`Page 3 of 24
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`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 4 of 17
`
`11.
`
`According to the Patents-in-Suit, prior art valve testing devices also
`
`experienced operational problem. For example, one prior art device used a flexible
`
`metallic bellows to pressurize. '538 Patent col.111.34-36. However, a higher load is
`
`required to drive the metallic bellows and can thus, impact the reliability of the test
`
`system and increase maintenance requirements which increases the already lengthy
`
`durability testing process.
`
`C. Overview of the Patents-in-Suit
`
`12.
`
`The Patents-in-Suit propose to solve these problems in the prior art.
`
`13.
`
`For example, the '935 Patent covers a device for accelerated testing of
`
`valved prosthetics with several components including a test chamber and an "excess
`
`volume area" that is connected to a return chamber. The excess volume area and return
`
`chamber within the test chamber are shown below:
`
`4
`
`Page 4 of 24
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`

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`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 5 of 17
`
`Fluid return chamber
`
`~ - - - _ ;Holder for test sample of
`prosthetic valve
`
`126
`
`120
`
`111
`
`Fluid
`return
`conduit
`
`Pressure source
`
`14.
`
`Another patent, the '224 Patent, covers a method for operating a test system
`
`with an excess volume area. The '224 Patent describes a method that includes storing a
`
`volume of the test fluid (which approximates blood) in an "excess volume area" when the
`
`system is in a "drive" stroke of the system that opens the prosthetic valve and releases the
`
`fluid from the area during the "return" stroke of the system.
`
`15.
`
`The excess volume area improves the testing environment by minimizing
`
`unnatural and undesirable pressure spikes and provides advantages of speed and
`
`longevity in the drive system. When the system is driving test fluid through the
`
`5
`
`Page 5 of 24
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`

`

`- ·-.~.· .. ,
`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 6 of 17
`
`prosthetic valve, the excess volume area is able to store the excess volume downstream of
`
`the prosthetic test valve. Tbis can alleviate some of the system pressure during the drive
`
`stroke. The excess volume area also provides compliance that controls the resistance and
`
`the forward flow pressure gradients across the valve, and minimizes unnatural and
`
`undesirable pressure noise or spikes. During the reverse stroke of the motor when the
`
`valve is closing, the excess volume area and compliance helps to build back pressure on
`
`the valve, return the downstream volume to the pump and minimize unnatural and
`
`undesirable valve closing pressure spikes, i.e., recoil, that can negatively impact the
`
`durability of the prosthetic test valve.
`
`16.
`
`The Patents-in-Suit offer potential advantages for heart valve durability
`
`testing compared to the prior art. The use of the excess volume area and the avoidance of
`
`pressure spikes allows the system to better comply with the rigors of the durability testing
`
`standards without exposing the test valves to undesirable, excess, and clinically irrelevant
`
`pressures.
`
`D. Infringement Analysis of DuraPulse Test System
`
`17.
`
`I understand that the accused device in this case is the DuraPulse Heart
`
`Valve Test Instrument ("DuraPulse"). To understand the components of the DuraPulse
`
`and their operation, I have reviewed the following: the TA Instruments website offering
`
`the DuraPulse for sale, the sales brochure for the DuraPulse attached to the Complaint in
`
`this case, pictures of the DuraPulse included in BDC's motion for preliminary injunction,
`
`a video of the operation of the DuraPulse available at
`
`https://www.youtube.com/watch?v=KgmpQCRrYpQ, and U.S. Patent No. 9,662,210
`
`6
`
`Page 6 of 24
`
`

`

`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 7 of 17
`
`("the '210 Patent"), attached hereto as Exhibit B. The '210 Patent belongs to Defendant
`
`TA Instruments-Waters, LLC ("TA Instruments"). The '210 Patent is entitled "System
`
`for Testing Valves" and, based on the diagrams and description, appears to describe the
`
`DuraPulse. In addition, I understand that BDC's CEO Dr. Craig Weinberg has observed
`
`the DuraPulse and the '210 Patent describes that product.
`
`18.
`
`I understand that the patent infringement analysis involves two steps: ( 1)
`
`claim construction, and (2) comparison of the accused product to the construed claims. I
`
`understand that direct infringement of an apparatus claim requires that each and every
`
`limitation set forth in a claim appear in the accused products. I further understand that
`
`direct infringement of a method claim requires all steps of the claimed method to be
`
`performed by or attributable to a single entity.
`
`i.
`
`Claim Construction
`
`19.
`
`I understand that claim terms are to be given the ordinary and customary
`
`meaning of the term as evaluated from the perspective of one of ordinary skill in the art at
`
`the time of the invention. I further understand that the claim term is to be read in context
`
`of the claim itself and in the context of the entire patent, including the specification, but
`
`that limitations from the specification should not be read into the claims.
`
`20.
`
`Based on context, including both the claims and the specification, the
`
`person of ordinary skill would understand that the term "compliance chamber" to mean
`
`"a cavity or volume that functions to absorb some of the pressure in the system." This is
`
`explained directly in the specification of the Patents-in-Suit. See, e.g., '538 Patent col.8
`
`11.59-62. The specification explains that the chamber or chambers absorb some of the
`
`7
`
`Page 7 of 24
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`

`

`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 8 of 17
`
`pressure placed upon the fluid in the t~st chamber and can also impact the recoil.
`
`Likewise, the compliance chamber minimizes the effect of rapidly changing pressure
`
`gradients associated with accelerated testing. Finally, the compliance chamber is "a
`
`cavity or volume" because the specification notes that it may be air or another gas and
`
`may directly contact the fluid or may be separated from the fluid by a membrane.
`
`ii.
`
`Comparison of Claim Elements to DuraPulse
`
`21.
`
`It is my opinion that the DuraPulse infringes at least claims 1 and 9 of the
`
`'935 Patent. In addition, it is my opinion that use of the DuraPulse infringes at least
`
`claims 1 and 6 of the '224 Patent.
`
`22.
`
`The DuraPulse includes all the elements of the Patents-in-Suit. For
`
`example, an image of the DuraPulse is shown below, as noted it has a test chamber with
`
`an excess volume area:
`
`Test chamber
`
`23.
`
`The DuraPulse also has a drive motor that operates the system at an
`
`8
`
`Page 8 of 24
`
`

`

`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 9 of 17
`
`accelerated rate:
`
`4--------- [A] Pressurizable test
`chamber
`
`1f::"'"------[B] Drive motor that
`1s a pressure source
`and operates at 900-
`1800 beats per minute
`
`24.
`
`As explained in the following claim charts, it is my opinion that due to
`
`these features, and the other features discussed in the charts, that the DuraPulse infringes
`
`claims of the Patents-in-Suit.
`
`25.
`
`The '935 Patent:
`
`Claim Limitation
`
`Claim
`Construction
`
`Presence of Limitation in DuraPulse System
`
`1. A device for
`accelerated cyclic
`testing of a
`valved prosthetic
`device
`..
`compnsmg
`
`The DuraPulse product is advertised by TA
`Instruments as a "Heart Valve Test Instrument."
`htt,g://www.tainstruments.com/heart-valve-
`durabiliiy-test-instrument/. A prosthetic heart
`valve is a valved prosthetic device.
`
`9
`
`Page 9 of 24
`
`

`

`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 10 of 17
`
`a pressure source
`configured to
`drive a test
`system fluid
`cyclically within
`the device above
`a normal
`physiological
`rate, at an
`accelerated
`pulsed rate of
`greater than 200
`beats per minute
`within the device;
`and
`
`The DuraPulse product is also touted by TA
`Instruments as a device "for accelerated heart
`valve durability testing."
`http://www.tainstruments.com/heart-valve(cid:173)
`durability-test-instrument/ ( description tab,
`emphasis added). TA Instruments notes that it
`can be run at over 30Hz, which is well above the
`normal human heart rate. Further, the TA
`Instruments website states that the DuraPulse
`"provides testing to the ISO 5840 standard for
`heart valve durability assessment." This
`standard requires cyclic testing.
`
`Therefore, the DuraPulse is a system for
`"accelerated cyclic testing of a valved prosthetic
`device."
`
`The DuraPulse device is shown above. It
`includes a pressure source ( contained in the
`base/cylinders in the above image). The device
`operates at a frequency of 15-30+ Hz. See
`http://www.tainstruments.com/wp(cid:173)
`content/uploads/TA Heart Valve Tester.pdf at
`3. Hertz (Hz) is a unit of measurement for
`cycles per second. Therefore, mathematically,
`15-30 Hz frequency corresponds to a rate of 900-
`1800 beats per minute for the test system fluid
`within the device.
`
`10
`
`Page 10 of 24
`
`

`

`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 11 of 17
`
`a pressurizable
`test chamber for
`containing the
`test system fluid
`and further
`compnsmg
`
`a fluid
`distribution
`chamber
`positioned on a
`first side of the
`valved prosthetic
`device and in
`fluid
`communication
`with the pressure
`source;
`
`The above image shows the DuraPulse test
`chamber. The red circle depicts the fluid line,
`showing that the test chamber contains test
`system fluid. In order for the DuraPulse to
`function as a heart valve testing system, the test
`chamber must be ressurizable.
`
`Fluid
`ion
`Distrib
`Chamb r
`
`Test sample hol
`prosthetic heart
`
`The above picture of the DuraPulse device
`shows a fluid distribution chamber positioned on
`one side of the prosthetic heart valve being
`tested. The clear cylinder below the fluid
`distribution chamber rovides fluid
`
`11
`
`Page 11 of 24
`
`

`

`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 12 of 17
`
`communication between the fluid distribution
`
`a fluid return
`chamber
`positioned on a
`second side of the
`valved prosthetic
`device;
`
`etum
`hambe
`
`a fluid return
`conduit both
`structurally and
`fluidly
`connecting the
`fluid distribution
`chamber to the
`fluid return
`chamber; and
`
`On the other side of the prosthetic heart valve
`(the side opposite the fluid distribution
`chamber), is a fluid return chamber, shown with
`the red arrow.
`
`Small channels, one of which is marked with a
`red arrow, surround the test sample holder. The
`'210 Patent refers to these as "return flow
`orifices." '210 Patent col.911.49-53 & fig.6b.
`The video of the operation of the DuraPulse
`confirms that these channels are in the system
`and allow return flow of test fluid between the
`fluid return chamber and fluid distribution
`chamber.
`
`12
`
`Page 12 of 24
`
`

`

`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 13 of 17
`
`an excess volume
`area capable of
`operating at the
`accelerated
`pulsed rate,
`wherein the
`excess volume
`area is in fluid
`communication
`with the fluid
`return chamber
`providing a
`volume for
`storing a volume
`of a test system
`fluid when the
`test system fluid
`is under
`compression.
`
`These conduits allow test fluid to move from the
`fluid return chamber back to the fluid
`distribution chamber. In other words, the
`conduits "both structurally and fluidly" connect
`the fluid distribution chamber and the fluid
`return chamber.
`
`xcess
`olume
`
`luid
`eturn
`chambe
`
`The excess volume area is indicated with a red
`arrow. As discussed above, the device operates
`at an accelerated rate. Therefore, the excess
`volume area is "capable of operating at the
`accelerated pulsed rate."
`
`Moreover, as shown, test fluid is able to move
`from the fluid return chamber to the excess
`volume area. In other words, the two are "in
`fluid communication." This is confirmed by the
`specification of the '210 Patent, which discusses
`the flow of test fluid into the excess volume area
`from the fluid return chamber. '210 Patent
`col.IO, 1.66-col.l l, 1.22.
`
`When the test system fluid is under compression
`it flows through the valve into the fluid return
`chamber. A portion of this fluid is stored in the
`excess volume area as shown below:
`
`13
`
`Page 13 of 24
`
`

`

`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 14 of 17
`
`9. The device
`of claim 1,
`wherein the
`excess volume
`area comprises a
`compliance
`chamber defining
`a cavity within
`the fluid return
`chamber.
`
`"Compliance
`chamber" is a
`cavity or
`volume that
`functions to
`absorb some of
`the pressure in
`the system.
`
`Excess
`
`(
`
`As the image shows, the excess volume area is a
`cavity within the fluid return chamber.
`
`In the '210 Patent specification, it notes that this
`airspace is a "compliancy feature." '210 Patent
`col.7, 11.51-52. In other words, when the fluid is
`compressed, the airspace absorbs some of that
`pressure, working as a gas spring. '210 Patent
`col.11, 11.8-22,32-34. Therefore, the excess
`volume area com rises a com liance chamber.
`
`14
`
`Page 14 of 24
`
`

`

`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 15 of 17
`
`26.
`
`The '224 Patent
`
`Claim Limitation
`
`1. A method for
`operating an
`accelerated cyclic
`test system for
`evaluating a
`valved prosthetic
`device comprising
`
`driving a test
`system fluid
`cyclically above a
`normal
`physiological rate,
`at an accelerated
`pulsed rate of
`greater than 200
`beats per minute
`within the test
`system;
`
`storing a volume
`oftest system
`fluid in an excess
`volume area
`during a system
`driving stroke that
`opens the valved
`prosthetic device;
`and
`
`Claim
`Construction
`
`Presence of Limitation in DuraPulse System
`
`As discussed above, the DuraPulse is a device
`used for accelerated heart valve durability
`testing. Therefore, any method for operating
`the DuraPulse is a method for operating an
`accelerated cyclic test system for evaluating a
`valved prosthetic device.
`
`The DuraPulse system has a linear motor that
`operates at between 15-30 Hz.
`http://www.tainstruments.com/wp-
`content/up 1 oads/ElectroF orce-Cardio-Test(cid:173)
`Instruments. pdf at 13. When in operation the
`linear motor drives the test fluid.
`Mathematically, 15-30 Hz corresponds to a
`cyclical pulse rate of between 900-1800 bpm.
`I understand that the ISO 5850 requirements
`define "normal physiological rate" as between
`30-200 beats per minute. Therefore, the
`DuraPulse device has a test system fluid
`cyclically above ·a normal physiological rate.
`
`,..._ ___ _i.:.Exces
`volu e
`area
`
`Fluid line
`
`15
`
`Page 15 of 24
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`

`

`. . _,:-.. · .. · ..
`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 16 of 17
`
`releasing the
`stored volume of
`test system fluid
`during a return
`stroke that closes
`the valved
`prosthetic device.
`
`During the driving stroke, the DuraPulse
`system stores working fluid in an excess
`volume area shown in the image at the top of
`the left-hand chamber.
`
`As described in the specification of the '210
`Patent, as a bellows compresses the test fluid
`(i.e., during the drive stroke), fluid flows
`through the valve causing it to open, which
`causes some test fluid to then compress the air
`and thereby move into the previously occupied
`airspace (i.e., the excess volume area). '210
`Patent col.11, 11.12-22.
`
`The fluid
`from the
`excess
`volume
`area drains
`as fluid
`flows
`through
`return
`ports to th
`other side
`ofthe
`closed
`valve.
`
`L-------'"'~
`
`....._=..:L-....:.;..J1;...__;~ -=::....:
`
`During the return stroke, the valved prosthetic
`device closes and the stored volume is
`released as the working fluid flows out of the
`second chamber through a return path in the
`ports surrounding the valve.
`
`As described in the specification of the '210
`Patent, as the bellows is drawn back (i.e.,
`during a "return stroke"), fluid is released
`from the excess volume area causing an
`increase in the volume of the airspace. '210
`Patent col.11, 11.23-31. This is shown in the
`
`16
`
`Page 16 of 24
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`

`

`CASE 0:17-cv-03403-DWF-SER Document 41 Filed 11/22/17 Page 17 of 17
`
`video of the operation of the DuraPulse as
`well.
`
`6. The method
`of claim 1, further
`compnsmg
`compressmg a
`· volume of a
`compressible gas
`with the volume
`of test system
`fluid to provide a
`spring force
`counter to and in
`response to a
`pressure on the
`test system fluid
`when the volume
`of test system
`fluid is stored in
`the excess volume
`area.
`
`Air
`
`Fluid
`
`When the return fluid chamber fills with test
`fluid, it compresses the air in the excess
`volume area providing for storage of
`additional fluid volume, while also providing a
`spring force that is counter to and in response
`to the pressure on the test fluid. Indeed, the
`specification of the '210 Patent specifically ·
`notes that the airspace "functions as a gas
`spring." '210 Patent col.11, 1.34.
`
`I declare under the penalty of perjury that the foregoing is true and correct.
`
`Executed on
`
`i ( /z.:z.. , 201 7 in
`
`J- ',)..Io LA- I<&°$ J ,nµ'
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`EXHIBIT A
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`6318 White Owl Drive
`Lino Lakes, MN 55014
`(651) 484-4368 (home)
`(651) 442-4361 (mobile)
`mgirards@comcast.net
`
`
`MICHAEL J. GIRARD, P.E.
`
`
`
`
`
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`
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`
`
`PROFESSIONAL PROFILE:
`Technical business leader with over 37 years of engineering and leadership experience, including the last 27 years in
`the medical device industry. Proven track record of developing products and technologies to drive business growth
`for US based and international organizations from start-up level to industry leaders. Demonstrated ability for
`creating technical strategic vision, implementing plans and building technical teams to support the strategy. Provided
`leadership and development for R&D groups of up to 25 people in highly cross-functional environments.
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`PROFESSIONAL EXPERIENCE:
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`April 2015 to
`Present
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`Girard Technical Services, Inc. – Lino Lakes MN
`President - Consultant
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`Independent consulting services for R&D, engineering and technical management focusing on the medical device
`industry.
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`January 2015 to HLT, Inc. – Bracco Group, Maple Grove MN
`April 2017
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`Vice President, Research & Development – Reporting to General Manager
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`April 2009 to
`January 2015
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`HLT is a medical device company owned by the Bracco Group in Milan Italy that is developing products for
`Transcatheter Aortic Valve Implantation (TAVI). The company experienced deployment issues and halted a clinical
`feasibility study in late 2014 just prior to joining HLT. Initial responsibilities involved leading the redesign and
`development of the delivery system, but then took over the entire R&D group in mid-2015. Reorganized and
`developed the R&D department into a strong team of 20 engineers and technicians. Both the valve and delivery
`system were redesigned and design verification testing completed to demonstrate significant improvement in
`performance from the system that failed in 2014. The redesigned system resumed use in a clinical trial in late 2016
`and now has successfully implanted valves in five patients. In addition to leading the R&D efforts, the Product
`Development Process (PDP) was overhauled to be more effective, a short and long-term product development
`strategy was created and the patent portfolio was managed and expanded to protect the technology. The development
`strategy drove the initiation of several successful projects to fill the product pipeline with further improvements and a
`next generation system.
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`JVT R&D Corporation/JenaValve, Irvine CA
`JenaValve Technology GmbH, Munich Germany
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`Head of Valve Development – Reported to VP of R&D (11/12 to 1/15), Reported to CEO (4/09 to 11/12)
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`JenaValve is a company developing and marketing products intended for the treatment of aortic valve disease based
`on catheter delivered prosthetic heart valve technologies. Started with the company at the early start-up stage
`providing technical expertise and leadership. Responsible for all valve engineering, development and manufacturing
`activities as the company grew from initial prototypes through the clinical trial and commercialization with two
`implantable valve product lines. Included extensive international travel to manage activities and interact with
`company personnel, outside development and contract manufacturing partners in multiple countries. Key
`responsibilities and accomplishments included the following:
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`•
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`Porcine root heart valve for the 32F transapical delivery approach:
`o
`Finalized the development and manufacturing processes
`o Coordinated in vitro valve testing and manufacturing of the prostheses to support First-In-Man
`(FIM) clinical studies started in 10/09
`o Coordinated all in vitro valve testing for Regulatory Submissions to obtain CE Mark approval
`obtained 9/11
`o Managed valve manufacturing and production activities with a UK based manufacturing partner
`through the commercial launch of the product in Europe.
`o Transferred manufacturing processes for the porcine root prosthesis to a 2nd source manufacturing
`partner in Canada to increase output and minimize production risks.
`Implemented manufacturing improvements to double manufacturing yields from 30% to over
`60%
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`o
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`MICHAEL J. GIRARD, P.E.
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`Pericardial heart valve for the 22F transapical and 18F transfemoral delivery approaches:
`Performed directly and/or managed all design, engineering and development for the unique 2nd
`o
`generation prostheses product line
`o Coordinated all in vitro valve testing and manufacturing of the prostheses to support FIM clinical
`studies started in 12/13 and Regulatory Submissions to initiate CE Mark clinical studies in 2014
`o Managed valve manufacturing of the pericardial valve prosthesis with a Canada based
`development and manufacturing partner
`o Transitioned manufacturing management activities to a new JenaValve manufacturing team
`based in Irvine
`Inventor on several key US and International patent applications to protect unique prosthesis design
`features.
`Led the establishment of a valve R&D group in Irvine, CA.
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`ATS Medical, Inc., Maple Grove MN (now part of Medtronic, Inc.)
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`Consultant – Reported to VP of R&D
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`ATS Medical was a surgical cardiovascular medical device company. Provided expertise and services to support
`engineering and development activities. Responsibilities included cryogenic ablation product development and
`improvements for the surgical based Atrial Fibrillation (AF) treatment product line. Coordinated and led less
`experienced engineers with design, testing and implementation activities. Investigated new cryogenic technologies
`for a 2nd generation AF treatment product platform.
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`St. Jude Medical, Inc., St. Paul MN (now part of Abbott Laboratories)
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`Senior Director, Research & Development – Reported to VP of R&D, Cardiovascular Division (9/06 to
`4/08), Reported to Division President, Cardiac Surgery Division (4/05 to 9/06)
`
`Responsible for the management and leadership of all research and development activities for the cardiac surgery
`business. This included a department of 25 engineers, scientists and technicians with an annual expense budget of
`approximately $6M. Some of the key individual and group accomplishments and activities include the following:
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`May 2008 to
`April 2009
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`April 2005 to
`April 2008
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`•
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`• Responsible for developing business portfolio technology strategy.
`•
`Prepared and presented yearly operational plans and 5 year strategic plans to upper management for the
`cardiac surgery business.
`Launch of new products and line extensions of existing products within the cardiac surgery product
`portfolio. Products launched from 4/05 to 4/08 are expected to generate approximately 20% of Division
`revenue in 2008 ($60M).
`• Completed development and gained approval to start an IDE clinical trial for a completely new aortic tissue
`valve platform.
`• Developed technical strategy, negotiated outside collaborative partnerships and initiated development
`programs on two key future product platforms:
`o Transcatheter beating heart aortic valve replacement
`o
`Polymer valve
`• Worked with legal department and outside attorneys to manage extensive IP portfolio, including filing
`more than 20 key new patent applications for novel technologies.
`Primary technical interface for evaluation of new technologies and business opportunities with physicians
`and other outside organizations.
`Provided materials and analytical chemistry testing for entire Division
`
`•
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`•
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`October 2003 to Impres Medical, Inc., Edina MN
`April 2005
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`Vice President, Research & Development – Reported to Chief Executive Officer
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`Impres Medical was a small start-up company developing technologies in the area of gynecology. Responsibilities
`included directing all research and development strategies and activities focused on demonstrating concept feasibility
`and the development of an intrauterine implant device and delivery system to treat abnormal uterine bleeding.
`Coordinated the device design, manufacture and pathological evaluations of biological tissue response of the device
`in preclinical and clinical studies. Filed several key pieces of IP based on very unique device tissue response and
`performance. In addition, key support was provided to the CEO to help company fund raising activities.
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`MICHAEL J. GIRARD, P.E.
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`May 1998 to
`October 2003
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`Acorn Cardiovascular, Inc., St. Paul MN
`
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`Director, Product Development – Reported to Chief Technology Officer (11/98 to 10/03), Reported to
`President/CEO (5/98 to 11/98)
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`Acorn Cardiovascular was a start-up company developing a Class III implanted Cardiac Support Device (CSD) that
`provided mechanical support for the ventricular portion of the heart to treat congestive heart failure. Responsibilities
`included the overall management and leadership for all product development activities. Was the second hired
`employee in an instrumental role helping to build the staff, infrastructure and lead development efforts required to
`take the CSD from concept to a clinical and commercial product. This included defining and implementing the
`product development procedure framework to assure satisfying all QSR requirements.
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`The CSD, packaging and accessories for implantation were developed and ready for first clinical use in only 12
`months, which exceeded initial company expectations. Key responsibilities, activities and challenges that were met
`included the following:
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`• Hired staff to support product development and other operational functions.
`•
`Planned and helped coordinate build-out and equipment set-up for lab, prototype shop and pilot
`manufacturing in a new facility.
`• Created Product