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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________________________________________
`MEDTRONIC, INC., AND MEDTRONIC
`VASCULAR, INC.,
`
` Petitioners,
`
`vs.
`
`TELEFLEX INNOVATIONS S.A.R.L.,
`
` Patent Owner.
`___________________________________________________
`IPR2020-00126 (Patent 8,048,032 B2)
`IPR2020-00127 (Patent 8,048,032 B2)
`IPR2020-00128 (Patent RE45,380 E)
`IPR2020-00129 (Patent RE45,380 E)
`IPR2020-00130 (Patent RE45,380 E)
`IPR2020-00132 (Patent RE45,760 E)
`IPR2020-00134 (Patent RE45,760 E)
`IPR2020-00135 (Patent RE45,776 E)
`IPR2020-00136 (Patent RE45,776 E)
`IPR2020-00137 (Patent RE47,379 E)
`IPR2020-00138 (Patent RE47,379 E)
`___________________________________________________
`
` VIDEOTAPED DEPOSITION OF
` DEBORAH L. SCHMALZ
`
`DATE: November 12, 2020
`
`TIME: 10:32 a.m. Central Time
`
`PLACE: Veritext Virtual Videoconference
`
`REPORTED BY: PAULA K. RICHTER, RMR, CRR, CRC
` (By videoconference)
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`www.veritext.com
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`888-391-3376
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`Page 1
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`
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`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex.1766
`Medtronic v. Teleflex
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`Page 2
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`Page 4
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`1 INDEX
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`2 3
`
`WITNESS: DEBORAH L. SCHMALZ PAGE:
`4 EXAMINATION BY MS. TREMBLAY................ 7
`
`5 6 7
`
`EXHIBITS REFERRED TO: PAGE:
`8 EXHIBIT 1110 July 2006 Updates,
`9 VSIMDT00031726-31746............ 74
`10 EXHIBIT 1111 April 2007 Updates,
`11 VSIMDT00031755-31774............ 75
`12 EXHIBIT 1112 October 2007 Updates,
`13 VSIMDT00031792-31821............ 76
`14 EXHIBIT 1113 February 2008 Updates,
`15 VSIMDT00031851-31877............ 77
`16 EXHIBIT 2024 Product Requirements for
`17 GuideLiner,
`18 VSIMDT00030178-30181............ 55
`19 EXHIBIT 2025 Clinical Technical Report on
`20 Use of Catheters in a Coronary
`21 Application,
`22 VSIMDT00030139-30167............ 63
`23 EXHIBIT 2038 July 2008 Updates,
`24 VSIMDT00031912-31936............ 78
`25 EXHIBIT 2039 Declaration of Deborah Schmalz.. 35
`
`1 APPEARANCES
`2 ON BEHALF OF THE PETITIONERS (By videoconference):
`3 Ms. Emily J. Tremblay, Esq.
`4 Mr. Cyrus A. Morton, Esq.
`5 ROBINS KAPLAN, LLP
`6 800 LaSalle Avenue, Suite 2800
`7 Minneapolis, Minnesota 55401
`8 (612) 349-8500
`9 etremblay@robinskaplan.comm
`10 cmorton@robinskaplan.com
`11
`12 ON BEHALF OF THE PATENT OWNER (By videoconference):
`13
`14 Ms. Tara C. Norgard, Esq.
`15 Mr. J. Derek Vandenburgh, Esq.
`16 Ms. Megan E. Christner, Esq.
`17 CARLSON, CASPERS, VANDENBURGH & LINDQUIST
`18 225 South Sixth Street, Suite 4200
`19 Minneapolis, Minnesota 55402
`20 (612) 436-9600
`21 tnorgard@carlsoncaspers.com
`22 dvandenburgh@carlsoncaspers.com
`23 mchristner@carlsoncaspers.com
`24
`25 (APPEARANCES continued on next page)
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`Page 3
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`Page 5
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`1 (EXHIBITS continued)
`2 EXHIBIT 2040 8/26/05 Memorandum to Deborah
`3 Neymark from Rose Griffith Re:
`4 Weekly Staff Meeting,
`5 VSIMDT00030135-30138............ 66
`6 EXHIBIT 2041 October 2005 Updates,
`7 VSIMDT00029978-29995............ 70
`8 EXHIBIT 2109 5/2/06 GuideLiner Team Meeting,
`9 VSI_00000771.................... 81
`10
`11 (Original exhibits attached to original transcript;
`12 copies provided to counsel.)
`13
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`23
`24
`25
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`1 APPEARANCES (Continued)
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`23
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`ALSO PRESENT:
`4 Adam Wallin - Videographer
`5 Paul Zalesky
`6 Greg Smock
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`789
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`1 P R O C E E D I N G S
`2 THE VIDEOGRAPHER: We are going on
`3 the record at 10:32 a.m. Central Time on November
`4 12th, 2020.
`5 This is Media Unit 1 of the video
`6 recorded deposition of Deborah L. Schmalz being
`7 taken via Zoom and taken in the matter of
`8 Medtronic, Incorporated and Medtronic Vascular,
`9 Incorporated versus Teleflex Innovations,
`10 S.A.R.L., in the United States Patent and
`11 Trademark Office before the Patent Trial and
`12 appeal board; Case Number IPR2020-00128.
`13 My name is Adam Wallin from the firm
`14 Veritext, and I am the videographer. The court
`15 reporter is Paula Richter from the firm Veritext.
`16 Will counsel please identify
`17 themselves for the record.
`18 MS. TREMBLAY: Good morning. My
`19 name is Emily Tremblay. I'm an attorney with
`20 Robins Kaplan. Also with me today from Robins
`21 Kaplan is Cy Morton on behalf of Medtronic, Inc.
`22 and Medtronic Vascular, Inc. Also on the phone
`23 today is our expert, Paul Zalesky.
`24 MS. NORGARD: Good morning. I'm
`25 Tara Norgard on behalf of the witness and the
`
`1 First, as you know, I'm going to ask
`2 you a series of verbal questions, and you're going
`3 to do your best to answer them truthfully and
`4 completely. We're going to do our best to speak
`5 one at a time for the court reporter's benefit,
`6 and I'd just ask that you make sure that your
`7 answers are given verbally as opposed to by
`8 nodding your head yes or shaking your head no and
`9 that you do your best to speak slowly and clearly
`10 for the record. Is that fair?
`11 A. Yes.
`12 Q. And then before we get started today, is
`13 there anyone in the room with you today?
`14 A. No, there is not.
`15 Q. As we go through the questions today, if you
`16 don't understand my question, please ask me to
`17 rephrase it. I will assume that if you do answer
`18 my question, that you heard it and you understood
`19 it. Is that fair?
`20 A. Yes.
`21 Q. We will be taking breaks, but if you need or
`22 want one, please just let us know. I only ask
`23 that if I've asked you a question, that you answer
`24 it before we go on break so that there's not a
`25 question pending on the record. Is that fair?
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`Page 7
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`Page 9
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`1 respondents in this action. With me today is
`2 Derek Vandenburgh and Megan Christner, also with
`3 Carlson Caspers. And also joining us is
`4 Greg Smock, in-house counsel for Teleflex.
`5 THE VIDEOGRAPHER: Will the court
`6 reporter please swear in the witness.
`7 DEBORAH L. SCHMALZ,
`8 duly sworn, was examined and testified as follows:
`9 EXAMINATION
`10 BY MS. TREMBLAY:
`11 Q. Good morning, Ms. Schmalz.
`12 A. Good morning.
`13 Q. Could you please -- could you please state
`14 your full name for the record and spell your last
`15 name.
`16 A. Deborah Lynn Schmalz. The last name is
`17 spelled S-C-H-M-A-L-Z.
`18 Q. My name is Emily Tremblay. I'm an attorney
`19 with Robins Kaplan and I represent Medtronic, Inc.
`20 and Medtronic Vascular, Inc. Have you given a
`21 deposition before, Ms. Schmalz?
`22 A. Yes.
`23 Q. Okay. So you're familiar with the process.
`24 I'm going to go over just a few ground rules
`25 before we get started here.
`
`1 A. Yes.
`2 Q. Have you consumed any alcohol today?
`3 A. No, I have not.
`4 Q. Have you taken any controlled substances or
`5 prescription medication?
`6 A. No.
`7 Q. Is there any reason that you will not be able
`8 to answer my questions truthfully and completely
`9 today?
`10 A. No.
`11 Q. Do you have any questions about the process
`12 before we begin?
`13 A. Not at this time.
`14 Q. What did you do to prepare for your
`15 deposition today? And before you answer, I want
`16 to be clear that I'm not interested in any advice
`17 that you may have received from your attorneys,
`18 but I am interested in general in what you did to
`19 prepare.
`20 A. I reviewed the -- my prior statement that had
`21 been prepared in March, the documents that were
`22 referenced in that, and spoke to the attorneys in
`23 this matter.
`24 Q. Did you review any documents that aren't
`25 cited in your declaration?
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`1 A. No, I did not.
`2 Q. Did you speak with anyone other than your
`3 attorneys?
`4 A. No.
`5 Q. Did you do anything else to prepare for
`6 today?
`7 A. No.
`8 Q. Ms. Schmalz, I'd just like to discuss your
`9 background briefly before we get going. Where do
`10 you currently work?
`11 A. I currently am employed at a company called
`12 Ablative Solutions.
`13 Q. And what is your position with Ablative
`14 Solutions?
`15 A. My position is the vice president of
`16 regulatory affairs and clinical research.
`17 Q. Could you briefly describe some of your
`18 responsibilities in that role?
`19 A. Sure. My responsibilities include all
`20 corporate matters relative to clinical trial
`21 conduct and design, and negotiations with the
`22 associated regulatory agencies that we're dealing
`23 with.
`24 Q. And how long have you been with Ablative
`25 Solutions?
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`1 A. I joined Ablative Solutions in June of this
`2 year.
`3 Q. And where were you before you joined Ablative
`4 Solutions?
`5 A. Prior to working for Ablative Solutions, I
`6 was employed at a company called NeuroTronik, Inc.
`7 Q. What was your position with NeuroTronik,
`8 Inc.?
`9 A. My position at NeuroTronik was the vice
`10 president of clinical research, regulatory
`11 affairs, and quality.
`12 Q. Could you just briefly describe some of your
`13 responsibilities in that role?
`14 A. Certainly. In that role at NeuroTronik, my
`15 responsibilities, again, included all of the
`16 overall corporate responsibilities for clinical
`17 research, the regulatory affairs, interactions
`18 with agencies that governed our product, and in
`19 addition, I had responsibilities for the quality
`20 systems and quality functions within the
`21 organization.
`22 Q. And how long have you -- or excuse me. How
`23 long were you with NeuroTronik, Inc.?
`24 A. I started with them in February -- I'm sorry.
`25 I apologize. I started with them in June of 2019,
`
`Page 12
`1 and ended my time with them in February because
`2 the company ceased to operate. They had lost
`3 their funding.
`4 Q. And before you joined NeuroTronik in 2019,
`5 where were you employed?
`6 A. At a company called ReShape Lifesciences.
`7 Q. And what was your role with ReShape
`8 Lifesciences?
`9 A. My role at ReShape was as the vice president
`10 of regulatory affairs, clinical research, quality
`11 and compliance.
`12 Q. Were some of your responsibilities in that
`13 role similar to those that you've described with
`14 respect to your positions with NeuroTronik and
`15 Ablative Solutions?
`16 A. Yes, with the addition of compliance-related
`17 matters in terms of overarching compliance outside
`18 of the regulatory agency issues, like FDA matters.
`19 Q. And how long were you with ReShape?
`20 A. I joined ReShape in October of 2017 and
`21 remained there until I began my position at
`22 NeuroTronik.
`23 Q. We're just going to keep working our way
`24 backwards here.
`25 A. Okay.
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`Page 13
`1 Q. Where were you before you joined ReShape?
`2 A. Before that I was at a company called
`3 Medpace.
`4 Q. And what was your title when you were with
`5 Medpace?
`6 A. My title was the executive director of the
`7 medical device group.
`8 Q. And what were some of your responsibilities
`9 in that role?
`10 A. My responsibilities included the overall
`11 business direction for the medical device group
`12 within Medpace. Medpace is a contract research
`13 organization, so we provided clinical trial
`14 management services and regulatory affairs support
`15 services for companies that needed our assistance.
`16 So I had the overarching responsibilities for all
`17 of the staff members that supported sponsors.
`18 Q. And when did you join Medpace?
`19 A. I joined Medpace in May of 2013.
`20 Q. And before you joined Medpace in May of 2013,
`21 where were you employed?
`22 A. I worked for a company called Veniti. That's
`23 spelled V-E-N-I-T-I. And I was employed as their
`24 vice president of clinical, regulatory and
`25 quality.
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`1 Q. And could you just briefly describe some of
`2 your responsibilities in that role?
`3 A. I had the overarching corporate
`4 responsibilities for clinical trial matters,
`5 quality, and regulatory matters.
`6 Q. And I apologize if this is getting a bit
`7 iterative. I just want to make sure we have your
`8 full history here. Before you -- excuse me. When
`9 did you join Veniti?
`10 A. I started with them as a consultant in
`11 November of 2010 and formally joined them as an
`12 employee in March of 2011.
`13 Q. And before you joined Veniti in November of
`14 2010, where were you employed?
`15 A. For a short time I was working as an
`16 independent consultant, supporting a variety of
`17 different small companies based in the Twin
`18 Cities.
`19 Q. And before your time as an independent
`20 consultant, where were you employed?
`21 A. At a company called Entellus,
`22 E-N-T-E-L-L-U-S.
`23 Q. And what was your title when you were with
`24 Entellus?
`25 A. It was as the vice president of regulatory
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`Page 16
`1 before -- I think you joined Vascular Solutions in
`2 September of 2000; is that correct?
`3 A. That is correct. Before that time --
`4 Q. Before September --
`5 A. Oh, yeah.
`6 Q. Sorry, go ahead. Before September of 2000,
`7 where were you employed?
`8 A. The company that I worked at before Vascular
`9 Solutions was called Empi. That is spelled
`10 E-M-P-I. I was hired by Empi in -- I think in
`11 September of 1995. The months -- the months are a
`12 bit of a blur at this point. And I was hired as
`13 the director of regulatory affairs, clinical
`14 research, and quality for the company.
`15 In 1997 I was then promoted to the
`16 vice president role, overseeing those corporate
`17 functions.
`18 Q. And before Empi, where were you employed?
`19 A. Boston Scientific.
`20 Q. And what was your role with Boston?
`21 A. Regulatory affairs manager.
`22 Q. And how would your responsibilities as a
`23 regulatory affairs manager have differed from some
`24 of the responsibilities we've discussed so far?
`25 A. Well, this was more of an individual
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`1 affairs, clinical research, and quality and
`2 reimbursement.
`3 Q. That is such a surprising answer.
`4 A. I know.
`5 Q. Could you briefly just describe some of your
`6 responsibilities in that role for Entellus?
`7 A. I had the overarching corporate
`8 responsibilities for regulatory affairs matters,
`9 clinical research matters, reimbursement matters,
`10 and quality matters.
`11 Q. And when did you join Entellus?
`12 A. July of 2008 and I left in July of 2010.
`13 Q. And before you joined Entellus, where were
`14 you employed?
`15 A. Vascular Solutions.
`16 Q. I do want to come back and we'll obviously
`17 spend a fair amount of time today talking about
`18 your time at Vascular Solutions, but before you
`19 joined Vascular Solutions, could you give me kind
`20 of a high level sense of your experience coming
`21 into Vascular Solutions?
`22 A. Certainly. Would you like me to continue to
`23 work backwards or just generally -- generally
`24 discuss that?
`25 Q. Sure, let's just keep working backwards. So
`
`1 contributor role, although I did have someone
`2 reporting to me, but I had responsibilities for
`3 projects -- specific projects that Boston
`4 Scientific was working on, specifically with
`5 respect to securing approval through either
`6 510(k)s or PMAs through FDA.
`7 Q. And when did you join Boston?
`8 A. Probably May of 1991, spring of 1991.
`9 Q. Let's go back to Vascular Solutions.
`10 A. Sure.
`11 Q. So I believe you mentioned that you joined
`12 VSI as vice president of regulatory and clinical
`13 affairs; is that correct?
`14 A. I also had responsibilities for quality.
`15 Q. Quality systems?
`16 A. All aspects of quality, so that would have
`17 been the quality engineering group, plus quality
`18 systems.
`19 Q. And did you remain in that role until you
`20 left VSI?
`21 A. At some point in time, and I do not recall
`22 the exact date, the company brought in a vice
`23 president of quality because the job had grown so
`24 much. And so I retained the responsibilities for
`25 clinical regulatory and added reimbursement to my
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`1 title, but quality -- the quality functions
`2 were -- reported to someone else.
`3 Q. Understood. So to whom did you report in
`4 your time at VSI?
`5 A. To Howard Root.
`6 Q. And who is Howard Root?
`7 A. Howard was the president and CEO of the
`8 company.
`9 Q. About how many people reported to you in your
`10 vice president role?
`11 A. I'd have to look at an organization chart.
`12 It's been quite some time and I don't remember
`13 specifically the number of people in my various
`14 departments.
`15 Q. Sure. Would it have been the regulatory
`16 department that you were overseeing? I'm just
`17 trying to get a general sense of structure. I
`18 don't need exact personnel numbers.
`19 A. Yes. There was a regulatory affairs
`20 department, a clinical department, and a
`21 quality -- quality department.
`22 Q. Do you remember about approximately how many
`23 people would have been employed in each of those
`24 departments?
`25 A. Again, I'm -- not specifically. I would have
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`Page 20
`1 science with honors in biology and chemistry from
`2 Valparaiso University.
`3 Q. Do you have any graduate level degree?
`4 A. No.
`5 Q. Do you have a medical degree?
`6 A. No, I do not.
`7 Q. Do you have an engineering degree?
`8 A. No.
`9 Q. Have you ever designed medical devices?
`10 A. No.
`11 Q. Do you have any specialized training related
`12 to regulatory, clinical, or quality?
`13 A. I'm sorry. Could you repeat the question?
`14 You were breaking up just a bit.
`15 Q. Of course. Oh, of course. My apologies. I
`16 was asking, do you have any specialized training
`17 with respect to regulatory, clinical, or quality?
`18 A. Yes. I have -- not formal training, but I've
`19 attended as ongoing education, multiple events
`20 throughout the years sponsored by either RAPS,
`21 which is the Regulatory Affairs Professional
`22 Society, or Medical Alley or other such
`23 organizations like that.
`24 Q. Let's talk a bit about your role at VSI as
`25 vice president of regulatory and clinical affairs
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`1 to look at an org chart.
`2 Q. Would it have been more than ten?
`3 A. In total? Yes.
`4 Q. In each of the departments that you
`5 identified; regulatory, clinical, quality.
`6 A. Again, I'd have to look at an org chart. The
`7 quality group was the largest, but I don't have
`8 numbers for you. I'm sorry.
`9 Q. No problem. And I believe you mentioned that
`10 you left VSI in July of 2008; is that correct?
`11 A. That is correct.
`12 Q. And why did you leave?
`13 A. I had obtained a position at Entellus. In
`14 addition, Howard -- Howard and I had had
`15 conversations about a transition plan.
`16 Q. Did you leave on good terms?
`17 A. Yes. It was --
`18 Q. Can you say a little bit more about that?
`19 A. Did I leave on good terms? Ultimately -- I
`20 mean, yes, it was -- Howard actually did terminate
`21 me, but it was because I had another position that
`22 I had taken.
`23 Q. Could you briefly describe your educational
`24 background, please?
`25 A. Certainly. I graduated with a bachelor's of
`
`1 and quality, I guess. I just want to get a -- I
`2 know you mentioned the job title changed. But in
`3 general, what were your responsibilities during
`4 your time at VSI?
`5 A. In general, as I stated before, my
`6 overarching responsibilities were to provide
`7 strategic direction from a regulatory affairs
`8 perspective and a clinical research perspective.
`9 In addition, I -- in that capacity,
`10 I would have -- I did have oversight on all of the
`11 projects that were either being considered for
`12 development or in formal development following the
`13 quality systems that we had set up.
`14 Q. Could you say a bit more about the difference
`15 between the formal development path that you
`16 identified and the informal path, so I can
`17 understand that distinction a little bit more?
`18 A. Certainly. Just one second.
`19 Q. Oh, no problem.
`20 A. Yes. So from a regulatory affairs
`21 perspective and quality systems perspective, we
`22 had set up, you know, kind of a date by which
`23 early -- early activities, proof of concept,
`24 feasibility assessments, and development of
`25 prototypes and testing of those prototypes could
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`1 take place without having the formal -- formal
`2 phase reviews and documentation that was dictated
`3 once the company had decided to bring something
`4 completely forward to full testing to support
`5 regulatory approval.
`6 Q. So when something -- when a project would be
`7 identified as ready for full testing, I believe
`8 was the phrase you used, that's when it would
`9 enter the formal quality system process; is that
`10 right?
`11 MS. NORGARD: Object to the form of
`12 the question.
`13 THE WITNESS: Could you restate
`14 that, please?
`15 BY MS. TREMBLAY:
`16 Q. Sure. So I'm just trying to understand the
`17 dividing line between the informal, early concept
`18 work that you were just describing and the formal
`19 quality systems. When would a product move from
`20 informal to formal quality systems tracking?
`21 A. When enough information had been gathered to
`22 demonstrate the feasibility of the concept and
`23 prototypes that had been -- had been built by R&D,
`24 that enough was known about things like the --
`25 excuse me, the potential market size and the
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`Page 23
`1 regulatory pathway is when -- and -- is when we
`2 would make that decision. We, meaning
`3 corporately.
`4 Q. Do you know about how long, on average, a new
`5 development project would spend in the informal
`6 phase before it transitioned to the formal phase?
`7 A. Well, that's highly variable, and it depends
`8 on -- it depends on the product.
`9 Q. Understood. How did you track new product
`10 development?
`11 A. Could you clarify that question, please?
`12 Q. Sure. Let me ask a more specific question.
`13 Did you keep certain documents that
`14 tracked the progress of new development projects?
`15 A. Are you speaking of me specifically?
`16 Q. Yes, you personally. My apologies.
`17 A. Could you repeat the question, please?
`18 Q. Sure. I'm just trying to get a sense of what
`19 documents that you personally would have kept in
`20 your role that would have tracked new product
`21 development.
`22 A. I personally did not keep those documents or
`23 keep documents like that.
`24 Q. Who did?
`25 A. Who did? Are you asking for a name or -- I'm
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`1 not sure what you're asking. Could you clarify?
`2 Q. Or a title, a role in VSI who would have been
`3 the job responsible for that type of document
`4 keeping.
`5 A. That would have fallen within the R&D -- R&D
`6 area to document the progress of projects.
`7 Q. Do you understand new products -- strike
`8 that.
`9 Do you often track new products in
`10 terms of phases that they may be moving through?
`11 A. Could you repeat that question, please? I'm
`12 sorry. I want to make sure I understand what
`13 you're asking me.
`14 Q. Of course. So do you often track new
`15 development work or new project work in terms of
`16 the phase that the work may be in? For reference,
`17 I believe in your declaration you mention, for
`18 example, a concept development phase or a
`19 commercialization phase. I just want to get a
`20 sense of the phases that you may have used to
`21 track project development.
`22 A. Can I refresh my -- review my declaration on
`23 that point, please?
`24 Q. Well, we'll be getting to your declaration in
`25 a bit, so let's wait until I introduce it as an
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`1 exhibit, if that's okay. If you -- if you're
`2 unable to answer that now without refreshing your
`3 recollection, we can come back.
`4 So right now in general, can you
`5 speak to any phases that new project may have
`6 moved through?
`7 A. Well, you know, the -- again, going back to
`8 the distinction between the early prototypes and
`9 proof of concepts that were outside of the
`10 regulated, more -- the regulated process, there --
`11 I do not recall specifically from our SOP what we
`12 talked about in that very early prototyping and
`13 proof of concept phase.
`14 Once the decision had been made to
`15 take a product forward into more formal testing
`16 design to support regulatory approval, again, I
`17 don't have that SOP in front of me, so I don't
`18 recall what the phases were in that area of
`19 testing and design -- not design work, but
`20 development work, where we were, you know,
`21 supporting -- doing the testing to support
`22 regulatory approval. There were phases. I do not
`23 recall what they were called.
`24 Q. What was your role in the early phases, the
`25 proof of concept phase?
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`1 A. Are you -- can you rephrase that question,
`2 please, or clarify it?
`3 Q. Sure, yes. Were you involved in the early
`4 concept phase, or I believe you referred to it as
`5 the proof of concept phase?
`6 A. Yes, in the sense of having an understanding
`7 of the -- a general understanding of the concepts
`8 that were being discussed and explored within the
`9 research and development department. So yes, I
`10 had an awareness of them. And my specific role at
`11 that point in time would have been to -- to give
`12 an overview on the likely regulatory path for that
`13 product that was in concept, because
`14 understanding -- understanding that timeline is a
`15 key factor.
`16 Q. Did you prepare reports to VSI's board of
`17 directors in your role?
`18 A. Yes, I did.
`19 Q. What information would go into those reports?
`20 A. Excuse me. The information that was included
`21 in those reports included major activities for
`22 clinical trials that we had -- were undertaking.
`23 It also discussed, from a regulatory approval
`24 process, where we are with our negotiations with
`25 either FDA or our notified body governance, CE
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`1 Q. In your role as vice president of regulatory
`2 and clinical affairs, did you have a system or
`3 policy regarding recordkeeping?
`4 A. I don't recall at this point in time. I
`5 would have to look at our SOPs, what was in place.
`6 Q. I believe earlier you mentioned 510(k)s.
`7 What is a 510(k)?
`8 A. A 510(k) is one of the submission formats
`9 used to obtain market clearance for lower risk
`10 products with FDA.
`11 Q. Were you in charge of VSI's 510(k)
`12 submission --
`13 A. Yes.
`14 Q. -- in your role as vice president of
`15 regulatory and clinical?
`16 A. Yes.
`17 Q. What documents did you need from R&D or
`18 others to prepare a 510(k)?
`19 A. Let's see. So documents -- I mean, there's a
`20 long list of documents. But generally speaking,
`21 to prepare a 510(k), you would have to have
`22 developed -- developed labeling, included --
`23 inclusive of what goes on the box and pouch for a
`24 product. You have to incorporate also the
`25 instructions for use for a product. There are
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`1 marking, and gave general timelines about
`2 submission dates and expected approval dates.
`3 Q. How often did you provide reports to VSI's
`4 board of directors?
`5 A. For every board meeting during my tenure
`6 there. I --
`7 Q. Do you know about how often the board would
`8 meet?
`9 A. I believe quarterly.
`10 Q. Did you prepare reports to Howard Root, the
`11 CEO?
`12 A. No.
`13 Q. Did you provide any other types of reports or
`14 updates to anyone at VSI in your role?
`15 A. In terms of updates, could you -- I mean,
`16 could you clarify the question, please? I'm not
`17 sure I'm understanding exactly what you're asking.
`18 Q. Sure. Did you provide any kind of formal
`19 report or formal update on a regular basis to
`20 anyone other than VSI's board of directors?
`21 A. Nothing formal, no.
`22 Q. Informal?
`23 A. Informal, we would include Howard's Monday
`24 morning staff meeting where we talked generally
`25 about issues.
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`1 multiple test reports that cover a variety of
`2 different activities, including statistically
`3 based benchtop testing to look at product
`4 integrity, sterilization validation,
`5 biocompatibility test reports.
`6 In some cases there could have --
`7 there may be risk management documents. So it's a
`8 quite extensive list, but from a top level general
`9 perspective, all of those reports would need to be
`10 reviewed, collated and summarized in that 510(k)
`11 submission.
`12 Q. In your role as VP of quality, were there any
`13 policies regarding how documents were to be
`14 managed?
`15 A. We had -- excuse me. We had an SOP on
`16 document control. We also had a doc control
`17 department that managed the review and approval of
`18 those -- of those documents, again, you know,
`19 based on -- based on the SOP.
`20 Q. Do you recall any details of that SOP?
`21 A. Not specifically, no.
`22 Q. I believe you mentioned test reports as a
`23 category of document that would support a 510(k)
`24 submission. Could you say a little bit more about
`25 what kind of test reports those would be?
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`1 A. Well, examples would include biocompatibility
`2 test reports. You know, each product had to be
`3 tested fully for biocompatibility, so there would
`4 be multiple reports covering the various
`5 aspects -- aspects of biocompatibility.
`6 Typically, the reports generated by the test house
`7 would be summarized in an overarching test report
`8 that drew conclusions about biocompatibility.
`9 Other test reports would summarize
`10 the results of physical testing based on the
`11 protocol that had been -- had been written as a
`12 part of the design -- or the development process.
`13 So, for instance, it could be a test report on
`14 tensile testing that looked at the overall tensile
`15 strength of a catheter. So, you know, with -- I
`16 mean, I hope that answers your question, but those
`17 are examples.
`18 Q. Yes. No, that's helpful, thank you. You
`19 mentioned a tensile strength test. Are there any
`20 other kind of specific tests that would be found
`21 in a test report kit to support a 510(k)?
`22 A. Well, that's just one example, and each
`23 product has its own -- its own test plan. So, you
`24 know, there are multiple -- multiple tests that I
`25 have seen performed on catheters in the time that
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`1 A. Okay. Generally speaking, at the time when I
`2 was at Vascular Solutions, you know, the company
`3 sent out testing like biocompatibility because
`4 there was no -- there's no capability internally
`5 to perform biocompatibility. Unless there was a
`6 very specialized test that needed to be done, the
`7 bulk of the testing, from a functional engineering
`8 perspective, was done by the R&D department.
`9 Q. And I believe you said functional testing was
`10 performed in-house? Is that correct? I just want
`11 to make sure I understood your testimony.
`12 A. Yeah. Functional testing would be inclusive
`13 of those tests that I mentioned. You know,
`14 tensile testing, torsional testing, torsional
`15 strength. That's what I meant by functional
`16 assessments.
`17 Q. Okay. Understood. Thank you. And those
`18 tests VSI engineers or the R&D department
`19 typically performed in-house themselves, correct?
`20 A. At the time that I was at Vascular Solutions,
`21 yes.
`22 Q. What is a design history file?
`23 A. A design history file is the -- and again,
`24 that's -- that would have been defined in an SOP
`25 that we had in place at the time that I was there.
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`1 I've been working in this field.
`2 Q. So for catheters specifically, can you
`3 provide any other examples of different types of
`4 tests that you would see in support of the 510(k)
`5 in addition to the tensile strength test?
`6 A. Generally speaking, some other examples of
`7 test reports, and again, this is not applied to
`8 any particular product, but it could include --
`9 Q. Yeah. We're talking generally, yes.
`10 A. Okay. It could include torsional strength,
`11 meaning how strong is the catheter to, you know,
`12 rotational strength. It could be tortuosity
`13 testing to determine how the catheter tracks to
`14 its desired location. It could be, you know,
`15 fluid infusion