TRANSCRIPT
David Smith 00:04
Welcome to the Expert Witness Podcast. I’m your host, David Smith. I’m excited to introduce Dr. Ediuska Laurens to you today. Dr. Laurens has harnessed the magic of science and the boundless wisdom of industry to champion patient safety, ensuring that medical innovations bring healing and not harm. As an entrepreneur, innovator, and holder of two patents, she brings expertise in medical device product development, regulation, and quality. She is the founder of Genius Shield, a regulatory and quality compliance solutions company that de-risks and shields cutting-edge medical technologies, accelerating their safety and efficacy to the global market. Genius Shield proudly holds the Woman-Owned Small Business certification and stands as an esteemed partner of J-Labs Resource Hub, the prestigious Johnson & Johnson incubator. Dr. Laurens brings a wealth of experience and expertise to the realm of medical innovations. Having spent nearly a decade at the Fortune 500 medical firm Stryker, she led a global R&D team in the development of cranial maxillofacial implants from concept to global commercialization. Her pursuit of knowledge led her to conduct doctoral research in biomaterials at the renowned Cleveland Clinic Foundation, and to be a prolific author of scientific publications. Her contributions have earned her prestigious accolades including a Forbes feature, the Stryker Innovation Patent Award in 2017, and the Cleveland State University Women in STEM Award in 2020. As an invited participant of the 2020 United Nations Women and Girls in Science Assembly, she stands at the forefront of driving positive change in the industry. Having left her native Venezuela, she holds degrees in aerospace engineering, mechanical engineering, and a doctorate in biomedical engineering. Her left and right brain are constantly in harmonious battle. When she is not launching genius medical solutions, you may find her practicing yoga, meditation, capoeira, or traveling the world to attend Grand Slam tennis tournaments. Dr. Laurens, thank you so much for being here. I’m excited to speak with you today.
Ediuska Laurens 02:40
Thank you, David. Thank you for having me. I am very excited to be here today.
David Smith 02:45
Wonderful. All right. So, let’s jump right in. The first thing that I always like to ask people is, how were you introduced to expert witness work? It’s not a very common career choice. You don’t hear kids talking about it in elementary school. So, I’m always curious, how were you introduced to it, and how did you get into this field of work?
Ediuska Laurens 03:07
That’s right. Well, I was one of those people who had no clue about the existence of expert witnesses until a conversation with one of my very good attorney friends. He opened my eyes. He said, “You know, with your unique expertise, you would make a brilliant expert witness.” And I chuckled and said, “I agree.” But then I asked, “What exactly is an expert witness?” So, he explained, and I became super curious. I started doing my own research. The more I learned, the more intrigued I became, and I felt like it was a perfect fit for me. So, I started reaching out to more attorney friends seeking insights. And I even took the expert witness training with SEAK. Are you familiar with them? It is S.E.A.K.
David Smith 04:13
Yes, I’m familiar with them. They’re not a sponsor of the podcast, but they come up in almost every episode.
Ediuska Laurens 04:20
Yes, and so I—and it was really great, you know? Given my initial lack of knowledge, it really provided me with an understanding of what the profession entails, from expert reports to crafting a CV for the purpose. So, it was very beneficial for me. And that’s how I stumbled into this fascinating world of being an expert witness.
David Smith 04:50
That’s interesting. It usually takes someone to introduce you to it, right? Otherwise, you don’t know it exists.
Ediuska Laurens 05:01
Sadly, yes. It’s a great area, particularly for people with our background.
David Smith 05:12
Definitely. When you started expert witness work, did you face any hurdles? Did work come in slowly, or were you in high demand from the start?
Ediuska Laurens 05:29
Well, I think the main barrier, which may not be unique to me, but is generally applicable, is landing your first case. For me, the process was gradual, for sure. It took me about a year to secure my first case. When you’re new to this arena, that first case must be aligned so perfectly with your expertise in order to be retained. At least that was my experience. When I had a match, I quickly provided value and insights to the attorney that he wasn’t even aware of during our intro call. And that’s what led, you know, to my retention. During the waiting-for-a-case window, what I did is that I invested in training and joined, as I mentioned, SEAK and joined their directory, which unfortunately didn’t yield many conversations with attorneys for me. I know that Dr. Stein, who was here on your podcast, really likes it, and he gets a lot of cases from it. But you know, so perhaps it’s good for MDs and not so good for experts like me. And, to be honest, I initially held back from actively promoting myself as an expert witness beyond the SEAK directory because of the cautionary advice for experts about being on social media. This is what I learned in one of my SEAK trainings. I had recently launched an online presence for my consulting business and was uncertain about the boundaries there. And you know, my perspective on this has evolved, and so it’s completely different. And I’m okay with that. But I did hold back a bit at the beginning. And so maybe that’s why it also took me a year; I’m not sure. But ultimately, the most effective avenue for me to acquire more cases was joining the Expert Institute. I’ve found their platform incredibly valuable and would recommend it to anyone starting anew with a similar background. Although I’ve heard it might not be as beneficial for MDs, my experience has been overwhelmingly positive. And just to clarify, I’m not being compensated in any way to promote it. I genuinely believe it’s an excellent platform. The process is remarkably simple. You know, I receive an email notification when there’s a brief from a case review, then I log in to my dashboard to accept or decline it. If I accept, then I answer a few questions, the attorneys review my responses and profile. And if they want to learn more, there’s a 15-minute phone call conversation. And after that, they inform me whether or not I’ve been retained. So, I truly appreciate the platform’s user-friendliness and transparency there.
David Smith 09:03
Yes, that’s good. We’ve had positive experiences with the Expert Institute too.
Ediuska Laurens 09:09
Yes, I really like it. All right.
David Smith 09:10
Very good. That does seem to be a common barrier, just getting that first case or maybe even the first couple of cases. Once it’s like the attorneys, I guess what one attorney told me when I was first starting out, I worked in a company where there were other experts doing expert work. They said, you know, from our perspective, why would we hire the apprentice when we can hire the master? Right? It’s probably the perspective that a lot of them have. So, getting that first case or two under your belt really does make a difference.
Ediuska Laurens 09:47
Yes, and this supports what I was saying. I believe that it needs to be such a perfect match with your expertise. At least for me, I have the biomaterials side, the biomedical engineering side, and the FDA. All of this really came together in that case, and they all needed each other. I knew that there wasn’t going to be anyone else like me to help with this case. I think you’re right. If I were in their shoes, I would also prefer the master. That’s why, for that, the caveat is that very first case. It needs to be such a good, perfect match for it to lead to a retention.
David Smith 10:42
Absolutely. Could you share something about the types of cases you commonly work on? Of course, without sharing any confidential information. Could you give us an example that would call for your particular expertise?
Ediuska Laurens 11:02
Sure. Well, with a master’s and doctorate in Biomedical Engineering, specializing in biomaterials and an extensive experience in medical device product development, regulation, and quality, I primarily handled cases related to medical device litigations, as well as personal injury and wrongful death. Within these types of cases, I specialize in medical devices and biologics, and medical device product development, which includes design, manufacturing, commercialization, and medical device FDA regulation and quality compliance. This includes quality management systems. And you know, in medical device litigations, the focus is typically on medical device defects and recalls, which is directly tied to compliance with FDA regulations, like adequacy of warnings and allegations of product defects. In personal injury and wrongful death cases, I deal with situations where families have been profoundly impacted by tragic deaths or severe injuries resulting from medical devices. I have noticed that my expertise in FDA regulations and quality really adds significant value even when attorneys may not initially recognize it. Regulatory compliance is crucial in most medical product litigation cases, because it governs the process through which medical devices enter the market and are monitored based on their post-market surveillance requirements.
For instance, I have encountered cases where patients suffer complications from devices that were improperly used, leading to injuries including multiple surgeries. Manufacturers are required to adhere to labeling requirements, detailing the conditions under which the device is intended to be used safely and effectively. By analyzing the adequacy of the devices’ indications for use, and labeling requirements, I can, number one, assess if the manufacturer complied with the FDA requirements, including proper instructions for use, warnings, cautions, etc. I’m just very much focusing on labeling; there are so many other things like risks, and everything is all around quality and risk. And then number two, comparing those indications for use with the patient’s medical profile and the treatment received, have allowed me to find evidence of the devices being unsafely used on patients. In other cases involving clinical trials, for instance, I have discovered instances where patients should not have been included at all in a clinical trial due to their medical history and conditions conflicting with the device’s testing criteria and indications for use. This non-compliance with clinical trial procedures resulted in permanent injuries to these patients. So those are some examples, without you know, naming specific names and so.
David Smith 14:59
Yeah, that’s really interesting. It seems like there are a lot of similarities between the medical devices that you work with and the heavy equipment that we often work with. Labeling, warnings and reducing risk are very important in the design process and are so often overlooked or considered as secondary in our industry.
Ediuska Laurens 15:33
Yes, and once again, I feel like people think that the regulatory framework comes in at the very end. But from the moment that these devices are conceptualized, they are under this umbrella of design controls to be able to output something that is considered safe and effective for patients. And this is really at the heart of everything. So…
David Smith 16:11
Absolutely. When you look at the types of cases that you’ve worked on, do you find that most of them are local? Or do you work nationwide? Is that typical for someone with your particular expertise?
Ediuska Laurens 16:30
Yes, I operate nationwide. Medical devices, along with food and drugs, are governed by Title 21 of the Code of Federal Regulations. There are laws and rules that apply throughout the United States. That’s an exciting aspect of my work. I’ve handled cases from California to Wyoming, Pennsylvania, Massachusetts, and everywhere in between. That diversity of locations adds a dynamic element to my practice and keeps things interesting.
David Smith 17:05
Absolutely. There probably aren’t many people across the nation that have your particular expertise.
Ediuska Laurens 17:14
That’s right. That’s what I hear.
David Smith 17:20
Alright, so tell me a little bit, among all the different things that you do and that you have done, if you can, why do you do expert witness work? What do you enjoy about it?
Ediuska Laurens 17:32
As an expert witness I find this work incredibly intellectually stimulating and deeply meaningful. I get the opportunity to apply my breadth of knowledge and experience all the way from engineering and biomaterials to medical device product development, FDA regulation and quality and it has afforded me a fresh perspective of medical device post market surveillance, allowing me to delve deeper into this very critical aspect of medical device product development. It makes me a better medical device expert. Beyond the intellectual satisfaction, it allows me to apply my expertise and experience to contribute to the pursuit of justice, which is a fundamental aspect of our legal system. By meticulously analyzing evidence and upholding the highest intellectual standards, I strive to provide objective and impartial testimony that assists the court in reaching a fair and just decision.
David Smith 19:11
Yes, absolutely. I agree with that on both aspects. In our practice, we’ve found that doing expert witness work really helps us get better at designing products. And designing products really helps us improve at the expert witness work.
Ediuska Laurens 19:33
Absolutely. I find myself in that position as well. It’s really exciting.
David Smith 19:42
Excellent. If you were to give one piece of advice to someone who had just been assigned to their first case, what would it be?
Ediuska Laurens 19:54
Yeah, so much, but to be more concise, I think the most important thing would be to establish clarity and organization right from the outset. You know, gather and correctly categorize all data and documents shared with you and discuss them comprehensively during your initial meeting with the attorneys to clarify expectations and focus areas. It’s not unusual for attorneys, at least that has been my experience, to initially be taken aback by the volume of files they’ve provided only to later specify that they only want particular areas to be reviewed. Conversely, I’ve worked with some attorneys that prefer to look at everything, examine everything, because they are aware that they don’t know what they don’t know. And so, this process is very important for identifying any additional information needed, particularly during the discovery phase. And you know, ensure that you’re clear on the case’s current phase, whether it’s pre-suit or in discovery. I think it’s super important to align communication channels with the attorneys early on, prioritizing phone calls and video conferences, because, you know, pretty much everything is discoverable. Which brings me to getting familiar with the Federal Rules of Civil Procedure, Rule 26. That’s the Bible. And ensure that your CV is crafted to withstand cross-examination; it’s very important. And I would say, also, to make sure that your retainer contract is robust and comprehensive, protecting both parties’ interests and outlining expectations clearly from the outset. I think there’s so much more that I could say, but I think those, without overwhelming anybody, would be my advice for somebody going into their first case.
David Smith 22:18
Absolutely. Setting clear expectations from the beginning and understanding exactly what your role is can save a lot of headaches later on.
Ediuska Laurens 22:32
Absolutely.
David Smith 22:34
I agree with that. That’s good advice. So, in your opinion, what makes an expert more persuasive when they’re trying to explain complicated scientific principles to attorneys, the court, or the jury?
Ediuska Laurens 22:57
Yeah, and I would say this—it’s something to keep in mind, in my industry anyway, but stick to the facts, you know? The data does not lie. And apply appropriate procedures and methodologies to analyze those facts. You know, I think what I call ‘De-jargon information’ is very important in my case, considering both the engineering and the regulatory complexities. This is something that I’m passionate about even within my own industry, because without simplification, understanding becomes virtually inaccessible. So, you want to be understood, and you want to demonstrate that you can translate the complexities of your expertise and your discoveries into plain English. You do not want your jurors rejecting your opinion because they cannot understand them, or because they cannot understand your reasons for them. And you know, I’ve heard this before and I use it now: ‘A confused mind says no,’ or ‘rejects.’ And you know, you also do not want to burden your attorney with having to take the time in court to translate your information into plain English. So, I believe that by communicating clearly and effectively, you will be more persuasive, believable, credible, more likable—just the whole package.
David Smith 24:50
Absolutely. I’ve never heard that phrase that way, “De-jargoning” But I really like that. It rings true. There is so much jargon that a lot of times, when you’re involved in it every day, you don’t even realize that it’s jargon.
Ediuska Laurens 25:06
Exactly. And once again, it’s like it makes the information inaccessible and complicated. So, we want to be able to simplify and just be understood, because once again, a confused mind says no or rejects, right.
David Smith 25:29
Very good. I like that. So, we touched on this a little bit earlier, but we find that most experts would like to be involved in more cases. What have you found to be the most effective marketing technique? Or the best way to get new cases?
Ediuska Laurens 25:47
Yes, I definitely share that sentiment, for sure. Because I love this so much. But, you know, as I mentioned earlier, the Expert Institute has truly optimized my approach. And also, I think that finding not the how, but the who can do this marketing for you is so much more effective. And I love the team at Expert Communications. Again, I’m not being paid to promote the expert communications team, but they’re great. Meredith and her mother, and so on. And collaborating with fellow expert witnesses have been invaluable for me. And it’s precisely how I found my way onto your podcast. And personally, one of my goals this year is to attend more conferences where legal professionals gather, so I could potentially share my expertise and gain more insights into the legal world. And I don’t know, do you have any favorite conferences that you attend?
David Smith 27:01
In each state, they typically have a defense organization and a plaintiff organization. And each has at least one conference every year. Depending on where you want to work, you can attend those conferences. We have offices in Utah and Idaho, and we’ve been involved with both in the past. They also have these organizations at the national level, like the National Trial Lawyer Association and the Defense Research Institute, or DRI.
Ediuska Laurens 27:46
Yeah. Do you have any favorites?
David Smith 27:51
So, we haven’t done the national ones. Personally, I haven’t attended those, but we’ve been to the state ones and have found them to be good networking opportunities.
Ediuska Laurens 28:01
Okay, great. Yeah. Well, maybe I’ll go down to Idaho. I have that in mind now. That’s great. Thank you for sharing that.
David Smith 28:10
So, for you, Utah is particularly a hub for medical device manufacturing. There are many attorneys involved in those types of cases in Utah.
Ediuska Laurens 28:23
Yes, thank you for that. I’ll take note of that because it’s one of my goals for this year. Maybe we’ll manage to meet at one of these conferences in person.
David Smith 28:41
That’d be great. Now, switching gears a little bit, I understand that in addition to your expert work, you also do a fair amount of public speaking. Can you tell us how you got into that and what it entails?
Ediuska Laurens 28:59
Hmm. Well, people just started reaching out to me to participate in panels and speak at tech events, particularly those focusing on women in tech. My very first speaking engagement was thanks to Matthew Snyder, who I believe was involved with the International Society of Pharmaceutical Engineering, the ISPE, and he asked me to join their yearly Women and Pharma panel. I think, you know, from there, opportunities naturally flowed in. I believe that my active presence on LinkedIn played a role, as it allows people to become familiar with my expertise, particularly in developing medical device innovation and regulatory compliance. I have been invited to lecture on medical devices at Columbia University’s Department of Biomedical Engineering, which led to other panelist opportunities at Harlem Biospace. I’ve also spoken at various events, including ChickTech, FemTech, Swissnex, which is Switzerland’s hub for research and innovation, and the Maryland Tech Council, among others. So, speaking engagements, as you know, are something I truly enjoy as they allow me to share my knowledge on a large scale, and they also serve as a great marketing tool.
David Smith 30:52
All right. So, what types of audiences do you typically have at these places where you’re speaking? Are they medical students, or doctors? Or are they lawyers, or somewhere in between? What types of people are you normally speaking to?
Ediuska Laurens 31:12
Well, my audience is typically in the medical device innovation space, which covers everyone you just mentioned. This could be a biomedical engineer, a chemical engineer, or just a student at a university working on a medical solution. It includes those who are in the OR every day, like surgeons and nurses, who understand the issues for certain clinical applications and come up with ideas. It also extends to regular citizens whose families are suffering from a disease, and who, with their own specialties, come up with solutions. So, it’s really broad. I call it the medical device innovation space. This happens at universities or at JLabs, which is Johnson and Johnson’s incubator. I have not yet had the opportunity to speak at attorneys’ conferences, which is why I mentioned that one of my goals is to attend more of these, so I can hopefully get invited to speak. So, if you’re an attorney out there listening to this and need an amazing speaker, please reach out. But yes, that’s how I would describe my audience for these proceedings.
David Smith 32:54
Very good. Do you feel like public speaking has helped the expert witness aspect of your work? And if so, how?
Ediuska Laurens 33:05
Yeah, absolutely. You know, public speaking has many powerful benefits for us as experts. It helps establish your authority, facilitates networking, enhances your communication skills, expands influence, and educates others, keeping them up-to-date with what’s going on in the field. It’s a very powerful marketing and branding effort. Through speaking engagements, experts can showcase their knowledge, connect with potential clients, and contribute to the growth of the industry while building their personal brand and staying current with advancements in their field. So, I think there’s no losing in this – it’s all gain.
David Smith 34:10
Sounds like that’s something you would recommend to any expert.
Ediuska Laurens 34:16
Yes, absolutely.
David Smith 34:19
The importance of building your own brand as an expert is, I think, an understated part of marketing and really being good at this type of work.
Ediuska Laurens 34:31
Yes, absolutely. I highly recommend doing speaking engagements for experts for all the reasons that I just outlined.
David Smith 34:44
Absolutely, very good. So, if you could go back, is adding expert witness work as a service you provide something you would do again?
Ediuska Laurens 34:57
Absolutely, without a doubt. Professionally engaging expert witness work , not only intellectually stimulates me, as I mentioned, but also resonates with my desires to contribute to the pursuit of justice. And I see just as another way through which I can contribute to making the world a better place.
David Smith 35:45
Very good. Alright, so final question. How can attorneys find you if they want to get a hold of you?
Ediuska Laurens 35:56
Yes. So, I have my website, which is www.geniusshield.io. I can also be reached via email, which is my first name, Ediuska. You will probably have to spell that out, David, somewhere in the podcast.
David Smith 36:23
We’ll have a link, we’ll have a link or something.
Ediuska Laurens 36:27
So www.geniusshield.io. And definitely, you can find me on LinkedIn, as Ediuska Laurens.
David Smith 36:37
Awesome. Wonderful. Dr. Laurens, thank you so much for being here. It’s been wonderful talking with you. I appreciate all of your ideas and insights. I know I’ve learned a lot and I’ve appreciated getting to know you and talking with you today.
Ediuska Laurens 36:54
Thank you so much for inviting me. This has really been a great investment of my time. I appreciated all of your questions. And I’m hoping that this is helpful for those who are trying to get into the field or even those who are already in it with a similar background as mine. And yes, hopefully, it’s beneficial to those that get in touch with your podcasts. Thank you again for the invite.
David Smith 37:25
Absolutely. It was a pleasure to have you here and again, thank you.
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Go to www.geniusshield.io to learn more about Dr. Ediuska Laurens and her company or reach out to her on LinkedIn at: https://www.linkedin.com/in/ediuska-laurens/
Also, visit https://alpineeng.com/services/ to find an Engineering Expert Witness perfect for your needs.