
The Med-Tech Talent Lab
135 episodes — Page 3 of 3

Ep 36What I'd do if I lost my job tomorrow-A Headhunter's approach to landing on your feet fast
The traditional job search is broken...plain and simpleFurther, there's never been an easier time to gain direct access to decision makers given the digital world we live in.While some of the strategies we share in this episode may seem unorthodox to manythey are cutting edge and what we, as Headhunters, would do immediately if we lost our jobs tomorrow.In this session you'll learn:The importance of personal branding and what that meansThe power of creating value for others & how it translates into exploratory meetingsLeveraging LinkedIn's platform and power to your advantage...and so much more!

Ep 34How to Break Into Digital Health/SaMD/Software as a Medical Devices w/ Vivek Thakkar
If you have anything to do with the Digital Health/SaMD sector of Med-Tech you'll probably recognize the name Vivek Thakkar. Vivek is a Regulatory Affairs expert, especially as it relates to SaMD (software as a medical device) products. He has spent the last 13+ years building a storied career across several Medical Device and Digital Health organizations the likes of Abbott Vascular, Cardinal Health, and Genentech/Roche to name a few.Currently he serves as VP of Regulatory Affairs & Quality for Idoven. Idoven, has developed the world’s first cardiology-as-a-service platform powered by artificial intelligence that augments a clinician’s ability to identify, triage and diagnose patients at scale.Simultaneously, Vivek, as Principal of RegSpace, LLC, provides Regulatory Affairs Consulting to numerous organizations across the industry.Some of the highlights we covered during our episode together:-Digital Health sector update-Trials and Tribulations for getting Digital Health products approved and onto the market-How he broke into Digital Health without previous experience and how you can too...and so much more!

Ep 33How do you know if you're burned out w/ Manny Hernandez
Burnout is a serious, often overlooked, issue in the workplace. It affects our mood, our performance at work, but most importantly our relationships and overall mental health.Joining me for this very important episode was Mr. Manny Hernandez, the VP of Community & Partnerships at Thrivable. With a Masters in Engineering, Manny has Led a storied career working for the likes of Procter and Gamble Full Sail and the Diabetes Hans Foundation earlier on his career and having helped build culture and teams at great companies like Livongo (now known to the market as Teledoc) and Tidepool.He is passionate about the Diabetes community and regularly serves as an Advocate, Public Speaker, and Consultant in this space.In 2021 Manny made the decision to take a Sabbatical until just recently when he began serving as the VP of Community & Partnerships for a company called Thrivable which is a real-time market research platform.The organization helps patients and solution-makers work together to create the next generation of products and services.During his Sabbatical he ready over 80 books and discovered a variety of things about life and about himself that I’m sure he will share insights into during our conversation!Some highlights of what we discussed:-What were some lessons learned during your time away?-What would you say to those who would love to do the same, but can’t afford to financially? Alternatives for similar effect?-If you had to do if over, would you do it again? Anything differently?-How did you know it was time to come back to FT work?....and so much more!

Ep 32The Pros & Cons of Attending Industry Conferences
On one hand it can be enticing to take off a few days of work to attend industry-related conferences, but on the other it can be a bit stressful to leave your "day job's" responsibilities behind during that time. Is it worth it to do so? That's what this episode is all about!Some of the highlights:-The #1 reason why you should attend in-person-The secret to getting the absolute most out of your attendance-When you absolutely should not attend...and so much more!

Ep 31Hiring from your "gut" is detrimental
Often, we let conscious and sub-conscious bias cloud our judgement while we interview candidates and ultimately trust our gut to make hiring decisions.While "gut feel" is important, relying on it as the overarching decision maker as to whether you should pull the trigger to hire someone is very detrimental to your overall hiring process.In this episode, Mitch Robbins and Adam Saupe break this topic down piece by piece and offer up more objective solutions to implement into your hiring process that will ultimately drive stronger, longer-lasting hires for your organization.Some of the highlights covered:-Why hiring with your "gut" is detrimental-How various bias are at play during our decision making processes and what to do about it-The importance of creating a homogenized screening process-What an interview matrix is and how to utilize it effectively-Leveraging scorecards for interviewing...and so much more!

Ep 30Filling the talent void for impossible to fill positions w/ Acacia Parks
Have you ever had a role to fill that just seemed downright impossible? Not enough talent to interview yet no one ready to step up internally. Talk about frustrating!Joining me on for this episode was Dr Acacia Parks, the Chief Behavioral Health Officer at a company called Found which is an organization dedicated to improving people’s overall wellbeing by making evidence based weight loss accessible & affordable for all.Dr Parks, with her PhD in Psychology from the University of Pennsylvania, has an extensive background in research and behavior change strategy both as a professor and as a business leader regarding both mental and physical health conditions.Prior to joining Found, Acacia spent over 10 years with the Digital Health company, Happify Health, as an instrumental leader overseeing the program of research evaluating the effectiveness of Happify’s digital therapeutics.Some of the highlights we discussed:-Qualities she looks for when determining if someone is ready to be promoted-Her thought process behind deciding whether to recruit from the outside or try and promote from within-Advice/roadmap for other leaders caught in the dilemma of too much work and no one immediately available to hire or step up right away..and so much more!

Ep 29Transitioning back to the office
During this episode, Mitch Robbins and Adam Saupe tackle the challenges many are presented with as employers require their employees to begin transitioning back to an in-office working environment.Some highlights covered:-The questions you can ask about safety protocols-How to still maintain the benefits/flexibility of remote work even when transitioning back to the office-The hidden benefits to being back in the office that you haven't thought of...and so much more!

Ep 28The most overlooked interview question candidates MUST ask
When it comes to interviewing, candidates more often than not fail to ask this question. As a result, they walk away from the interview not knowing how they "performed", or what will happen next, if anything.During this episode, Mitch Robbins and Adam Saupe share the exact question and psychology behind the importance of asking it so that you can:-Give yourself a 67% chance of establishing closure to the interview-Give yourself a "second-chance" (more on this in the show)-Leave the interview with confidenceTune in to hear the exact question you need to ask during your next interview!

Ep 27Work-Life Balance is a Myth
The idea of this work-life in a way is a myth. Why? Because work and life are part of the same continuum. The definition of balance is 50-50 which is impossible when it comes to the idea of having "life" and "work" separately.During this episode, Mitch Robbins and Adam Saupe take this topic head-on and propose an alternative definition, that of "Work-Life Integration".Some highlights covered:-Work-life balance (aka integration) means something different to everyone-How to vet organizations'' cultures to ensure it aligns with your view points on this topic-How to set expectations and hold your employer accountable for work-life integration that works for you..and much more!

Ep 26What to do after you don't get the promotion
During this episode of the Med-Tech Talent Lab podcast, Adam Saupe and Mitch Robbins discuss mindset and strategies to consider if you are ever in a position where you were up for promotion but got passed over.Some highlights covered:-Before you decide it's over and time to move on from the organization, consider critical intel necessary to make this decision-The importance of being proactive to solicit feedback why you didn't get the promotion-Thereafter, do you know what the roadmap to promotion looks like internally?-Growth lies outside of our comfort zone-Cultural fit in promotions vs skillset..and much more!

Ep 25Real-Time Update on Med-Tech RA/QA Opportunities in the US
During this episode Adam Saupe and Mitch Robbins share a real-time market update as it relates to available Med-Tech Regulatory & Quality opportunities.

Ep 24Choosing Amongst Multiple Job Offers w/ Mitch R & Adam Saupe
In an employment market as fierce as the one we are experiencing right now, it's commonplace for candidates to receive multiple offers...very similar to many housing markets across the US these days.But, as a candidate, receiving multiple offers can add an additional layer of stress.How in the world do you choose, let along make the RIGHT decision for yourself?Let us help you with the action plan we've devised for you!Some highlights of what Adam Saupe and I cover during this episode:-Making the decision as logical/objective as possible by way of the job-offer matrixbefore adding in your intuition or "gut feeling"-Caliber of your prospective mentor -Tenure of the team-What the opportunity means to the trajectory of your career-Be as honest as possible with yourself of what you really want...and so much more!

Ep 23Nailing the TOUGH Interview Questions
Not all interview questions are treated equally, not by a long shot. The worst is getting caught flat-footed with the facial expression of a dear in headlights as a result of not being prepared for the tough ones.During this episode, Adam Saupe and I share tips, tricks, and strategies to ensure you thrive and nail these questions!Some highlights (interview questions) of what we cover:-Why are you interested in working here?-Tell me about your greatest weakness-What negative experiences have you had with previous supervisors?-Why should we hire you?...and much more!

Ep 22HUGE ANNOUNCEMENT for Med-Tech Reg Affairs Specialists (incl Sr & Principal)
During this episode, Adam Saupe & I share an announcement that has been years in the making. This idea is near and dear to our hearts and we hope by the execution of it that it truly generates immense value for Med-Tech Reg Affairs Specialists across the US and beyond.We announced the opening of #BRASS, or Bold Regulatory Affairs Specialist Society.An exclusive, peer-to-peer platform dedicated specifically to Med-Tech RA Specialists, Sr RA Specialists & Principal RA Specialists.What's the advantage of being in the group?-Access to colleagues from across the industry challenged by the same issues as you.-Tips, tricks, and strategies for career progression-Access to expert RA 'mentors in residence' available 5 days a week to answer your questions-Virtual happy hours for networking-Live panels of RA Execs discussing how they got to where they are, what they would do differently, what they look for when promoting and/or hiring...and so much more!The best part? IT"S NO-COST TO JOIN. mitch@theanthonymichaelgroup for details on how to get your login info.

Ep 21Regulatory Affairs Talent Are A-List Celebs-Great Power = Great Responsibility
It's a known fact that the employment market is most certainly a candidate-driven market. That is an understatement when it comes to the Regulatory Affairs space.In a way, RA Talent are like A-list Celebs where everyone is trying to court them and capture their attention. Hiring managers, HR & Talent Acquisition, and Headhunters alike.Some of the highlights we covered:-While Reg Affairs Talent is in the driver's seat, it's important not to abuse that position of power. You just never know when the market may turn. Be respectful. Don't ghost.-The grass isn't always greener when it comes to new opportunities-Don't get overwhelmed by feeling pressue to interview for every opportunity that comes your way. Be steadfast in the criteria important to you.-The power of great Headhunter relationships, especially when gainfully employed.-"Make hay while the sun shines"...NOW is the TIME to have conversations.-How to strategically position yourself for a raise when you know you want to stay...and so much more

Ep 20How to Retain Talent After Passing Over Them For a Promotion-Mitch R. & Adam Saupe
So you just passed over a valued employee and chose to promote someone else.How do you do immediate damage control to not lose this person?How do you "comfort" them and give them hope for their future internally?Adam Saupe and I take this head on and provide you with real-world, actionable strategies you can implement straight away.Some highlights we covered:-The power of empathy and validation-Clearly explain why they didn't get the promotion, but what they need to do next to keep moving forward-Double-down on engagement with them-Reinforce your willingness to continue to provide them with mentorship...and so much more

Ep 19Getting your company noticed and your jobs filled-Doug Fauth-Sr Dir TA-MicroVention
Many have labeled our guest today as a Talent Acquisition Visionary. Most recently he was recognized by CIO Views Magazine as one of the most influential leaders in the Talent Acquisition industry in 2022.I'm referring to Mr. Doug Fauth, the Sr Director of Global Talent Acquisition & Development at Microvention.MicroVention, founded in 1997, has pioneered the development of catheter-based, minimally invasive, neuroendovascular technologies. Doug joined the company in 2016 after working for companies like Ernst & Young, Broadcom Corporation, Activision-Blizzard, Life Technologies, and Southern California Edison (SCE).At the start of his career, which now spans over 25+ years, Doug worked in a College & University setting where he was involved in career counseling and bringing companies on-campus to interview and hire current students, later transitioning to internal talent acquisition for organizations.Some highlights of what we covered:-Rising above the noise to get a company's message in front of talent and have it make them take action-Doug's philosophy on Talent Branding and why it's so different from most-Leveraging job postings as valued real-estate and breaking away from worn-out ways of writing them that don't work anymore-An innovative way of communicating with your employees-Doug's take on Employee Value Propositions and how to create one so that candidates will take note and want to speak with you!...and so much more

Ep 18Michaela Hart-VP Quality-Roche-Let your people lead or let them leave?
Joining me on this episode was the VP of Quality Systems & Compliance at Roche Molecular Solutions, Ms. Michaela Hart. Michaela is a leader I personally have a lot of respect for. With her no BS style, she's led teams for the better part of 30 years for a variety of organizations, but primarily at Roche. She likes to go fast in business and in life being an avid race car driver!She really works her butt off to empower teams while holding them accountable.To help inspire other leaders, she wrote a book in 2015, "Let them Lead"..How to Command Less & Accomplish More (available on Amazon).She's also in the process of writing a brand new book which we discuss during the episode as well.-Hiring givers & firing takers-Performance management, what exactly does this truly mean?-Managing across multi-generational workforces and the key differences-The importance of having a personal 'board of advisors'-Michaela's upcoming book, "Let them leave"...and much more!

Ep 17How to choose the RIGHT Consultant (especially in Reg Affairs)-Tim Marjenin-MCRA
Joining me for this episode was Mr. Tim Marjenin, VP of Neurology Regulatory Affairs at MCRA, the leading Medical Device, Diagnostics, and Biologics CRO with Integrated Clinical, Regulatory, Reimbursement, Compliance, & Quality services.Prior joining MCRA, Tim worked for the FDA for 16 years as a Scientific Reviewer and then as a Assistant Director (Branch Chief) over the Neurostimulation Devices branch.During this epsiode, Tim and I discussed:-What he would want to ask prospective Consulting partners if he were the one choosing the Consultant-What Tim thinks start-ups often get wrong when it comes to the timing of engaging a Regulatory Consultant-How important is fee consideration when companies choose a Consultant-The #1 factor that should be considered when choosing a Consultant or Consultancy Firm?...and so much more!

Ep 16Med-Tech Startup Challenges & Resources-Duane Mancini-Project MedTech
I was so excited to host Duane Mancini, the Founder & CEO of Project Med-Tech, primarily because Duane and his team are adding so much value to the industry at large by way of the fantastic content they put out on a regular basis.Duane hosts the Project MedTech podcast where he interviews leading experts in the Medical Device industry on a variety of topics related to major successes, pitfalls, and trends.Recently, Project MedTech has morphed into a full-blown business of resources for Med-Tech startups at any phase the company is working through.For over 10+ years, Duane has held a variety of roles in the Med-Tech industry (Chemist, Sr Technical Advisor, and multiple Business Development roles with companies like NAMSA and LabCor.Duane holds his Bachelors and Masters degrees in Medicinal and Biological Chemistry from the University of Toldeo.Some of the highlights we discussing during this episode:-How Project Medtech support Startups and the resources they can provide-How crucial it is to understand Regulatory, Reimbursement, & Commercialization and how each affects business decisions-The most surprising feedback Duane has received from an Investor's point of view...and so much more!

Ep 15Peman Montazemi-Dir Engineering-Diality-Grow yourself to grow your business
My special guest for this episode was Mr. Peman Montazemi, the Director of Engineering at the Medical Device company called Diality.Peman is no stranger to formal education! He earned his Mechanical and Aeorspace Engineering degrees from the University of Virginia, his Masters in Biomedical Engineering from USC, and he is currently pursuing his Executive MBA from UC Irvine.Over the last 15+ years, Peman has been earning his stripes working for various medical device companies like Advanced Bionics, Smith & Nephew, and others.As I mentioned, today he is the Director of Engineering for Diality where he is responsible for building, traning, and leading a brand new team from the ground up.Diality is a privately held, series B-stage medical device company with a mission to develop solutions that help improve the care and lives of patients with kidney disease. The company's vision is a future where its technology enables all patients and partners to control kidney disease.Key highlights of what we discussed:Rapid growth = the necessity for rapid new skill development, or in other words, rapid professional developmentLayer 1 (A culture that is driven by leadership)-Expectations, vision, goals, miletones, targets, etc.Layer 2 (What do the individual teams need to accomplish?)-Tools necessary, internal vs external resources, project criticality, etc.Layer 3 (Personal skill gap)-Why parts of Peman's formal education has helped him the most on the business front?-What is he most excited about in the Internet of Medical Things space?...and so much more!

Ep 14Topaz Kirlew-VP Reg Affairs-Integra LifeSciences-Success through Adversity
I was honored to host Ms. Topaz Kirlew, a Vice President of Regulatory Affairs at Integra LifeSciences, and formerly at Apyx Medical.Topaz has over 25+ years experience in Quality and Regulatory Affairs across Biologics, Drugs, Medical Devices and Tissue/Cell Based Products. She's had the opportunity to work for a diverse range of businesses from very larger corporations like Danaher, specifically with Beckman Coulter, to small, yet rapidly growing organizations like Apyx Medical.During this episode, we discussed various situations of Adversity that Topaz remarkably overcame to be the successful female Executive leader she is today.Today, Topaz serves as a Vice President of Regulatory Affairs at Integra LifeSciences where she is responsible for developing and implementing Integra's regulatory strategy while providing leadership over submissions, compliance, advertising and promotional review as well as product registrations across the product portfolio for all of Integra's products.We discussed:-Her early, formative years. Where she grew up, her family life, etc.-How she got into the LifeSciences, and specifically Regulatory Affairs-The challenges she faced rising up through the ranks as a woman of color-Her perspective on the role and responsibilities of both a mentor and a mentee...and so much more!

Ep 13Jay Pendleton- Director of Strategy & Talent-A new way of recruiting talent
I was joined by Jameil or as many in the industry know him as “Jay” Pendleton, who is a Medical Device Sales leader with over 18 years experience in relationship sales and territory management.After crushing his own personal sales goals year over year as a high-performing intra-operative sales rep, he was promoted into management having built out a team of Regional Managers in the competitive Western US on behalf of Medtronic.Holding his bachelor’s degree in business with a minor in psychology Today he serves as Medtronic’s Director of Strategy & Talent for the Brain and Spine Therapies divisions. What exactly is a Director of Strategy & Talent you ask? Great question and I’m glad you asked because that’s a significant part of what we dug into with Jay.We also discussed the new YouTube podcast that Jay hosts called Sultans of Sales where he interviews a variety of Sales leaders and Surgeons all designed to connect people together in MedTech and other industries while improving people's lives through connections and storytelling.Some other key highlights we discussed:How he became the Director of Strategy and Talent.How did he come up with the idea for the role?With all of the momentum in the last few months that he has gained with the content that he puts out on social media, what's the purpose of it all and why does he think it is getting the attention that it is?What advice would he have for those Hiring Managers, Talent Acquisition Professionals, and HR folks who see the value in these types of strategies to build brand awareness and attract talent, but are nervous to get started?...and so much more!

Ep 12Michael Katz- Director of Quality for Viz.ai
I was joined by Mr. Michael Katz, Director of Quality for Viz.aiMichael has a Bachelors of Science in Human Biology from Boise State and Masters Degree in Regulatory Science from John Hopkins.His career is off to an impressive start having joined the Med-Tech industry in 2016 as a Regulatory Affairs Analyst.In 2018 he had the opportunity to make his way into the exploding Software as a Medical Device sector today and serves as the Director of Quality for a company called Viz.aiFor those unfamiliar, Viz.Ai the company was inspired by a patient who underwent a successful brain surgery but yet died because the surgery came too late. Dr. Chris Mansi, at Stanford Business School, joined forces with machine learning post-doc Dr David Golan and together they founded Viz.Ai with a goal of using artificial intelligence to make healthcare work faster and smarter. Not just to change, but to radically transform it. In essence, the organization uses AI to synchronize stroke care, reducing systemic delays that stand between patients and life-saving treatments.Some key highlights we discussed:-How did he get into the RA/QA space to begin with?-So many want to get into SaMD and are frustrated by the catch 22 of needing experience to gain experience. How did he land his role with Viz.ai?- It begs the question, are companies overlooking talent that very well could be successful and do a great job for the organization just because they haven't worked in a SaMD environment before?-What learning curve has he been going through as it relates to SaMD specifically?-Has he hired folks from outside the SaMD space? Did they face similar learning curves, or other challenges that he hadn't thought of prior to hiring them?-What has he found different, if anything about building a Quality (and Regulatory) program in a SaMD environment vs. a traditional Medical Device Company?

Ep 11Ed Nathanson-VP Talent and Branding at EQRx- Recruiting & Branding in 2021
I was joined by Mr. Ed Nathanson, Vice President of Talent and Talent Branding at EQRx.Over the last 30 plus years Ed has built a storied career holding multiple different types of roles within recruiting, human resources, talent acquisition and the talent branding space. From 2014 until 2020 he built an organization called Red Pill Talent which as a company had the singular mission to help companies be awesome at hiring. Ed and his team helped clients build world class internal recruiting and employment branding functions to attract and hire the best possible talent.Ed’s been featured multiple times both as a featured speaker or as the keynote speaker with companies like Linked In, Glass Door and Mass Bio just to name a few. In his current role as the Vice President of Talent and Talent Branding at EQRx, he’s building and leading a team that is responsible for executing cutting edge talent attraction and retention strategies as EQRx continues to scale.For those of you unfamiliar with the company, EQRx is really at the forefront of a revolution. The company is working to make medicines more affordable for people who need them, working to make drug pricing transparent, and reinstating the trust between the pharmaceutical industry and its patients.During our conversation, Ed and I discussed how the market of Talent Branding/Recruiting has evolved and how his passion turned into creating a business consulting to others.Some key highlights we discussed:- How he ended up creating a business consulting to others, etc.-How he would define what Talent Branding is.-How has the market changed over the last 18 months with respect to how companies need to be engaging with talent and how talent is (or isn’t responding)-How does he see the game of recruiting/branding continuing to evolve-Do job descriptions have their place? How should they be best utilized-Tools he's been having his team utilize to engage with talent-How does he monitor his team’s performance? Is there a metric for putting out content, or engaging with other’s content, etc.?

Ep 10Susan Andrews- Recruiting Manager-Penumbra-Insights from a Corporate Recruiter
I was joined by Susan Andrews, Recruiting Manager for a company called Penumbra. Susan is a recruitment enthusiast and candidate experience Manager with over 15 plus years of full life cycle recruiting experience across a variety of disciplines and environments including agency, corporate and professional services firms throughout the United States.She's got relevant experience as it relates to ATS Integrations whether that’s UAT, remediation, end user training and she has a variety of experience developing and implementing a best sourcing and recruitment practices and a variety of processes and recruitment techniques all while designing and facilitating training classes across different functional areas.Susan earned her bachelor’s degree from the University of Texas at Austin and she’s currently one of the recruiting managers at a company called Penumbra. If your not familiar with Penumbra, it is a global medical device organization headquartered in Alameda, CA, that designs, develops, manufacturers and markets novel products that address challenging medical conditions in markets with significant unmet need in both the neuro and vascular space.During our conversation, Susan and I discussed her role as an Internal Recruiter from responsibilities of an internal recruiter, to favorite social media platforms that she uses for recruiting.Some key highlights we discussed:-As a Corporate Recruiter, she constantly has a significant work load on her desk. How does she stay organized?-What is one thing she thinks Hiring Managers misunderstand about an Internal Recruiter’s role & responsibilities?-What social media platforms is she using these days for recruiting?-Which seem to be the most effective for engaging prospective candidates?-Are job postings giving the ROI they are meant to give? At all levels, or just lower level positions?-What is one of the most common mistakes she sees candidates making?...and so much more

Ep 9Dave Nazzaro- Sr Director of Hardware Engineering and Advanced Technologies- Insulet. Interviewing and hiring in technical functional areas
I was joined by Dave Nazzaro, the Sr Director of Hardware Engineering and Advanced Technologies at Insulet Corporation.Dave holds his Bachelor’s of Science degree in Mechanical Engineering from the University of Massachusetts at Lowell and for the last 17 years he has progressively risen through the ranks having worked for a variety of organizations including Fluident, Apple and of course Insulet.Dave was actually on the product design engineering team that was responsible for the development and launch of the first generation Apple watch. For those of you unfamiliar with Insulet Corporation, it is an innovative medical device company based in Acton Massachusetts. The company was founded in 2000 with the mission of improving the lives of people with diabetes. Specifically through the use of the revolutionary OmniPod Insulet Management System which delivers without any tubing in an automated fashion virtually pain free and it has two straight forward parts that communicate wirelessly. Insulet now also leverages the unique design of it’s pod by tailoring it’s Omnipod technology platform for the delivery of non insulin substantious drugs across therapeutic areas.During our conversation, Dave and I discussed both hiring and promoting practices.Some key highlights that we discussed:-When he hires, what are the core foundational attributes he looks for and how does he measure them ?-Does he value a technical skillset or a soft skillset more?-He himself, has successfully been promoted time and again…how has he put himself in position for these promotions? How did he go about figuring out what was necessary to accomplish to be put in position for promotion?...and so much more

Ep 8David Pudwill- Reg Affairs expert- What companies & professionals get wrong about Reg Affairs
I was joined by Mr. David Pudwill, a Regulatory Affairs expert for both medical devices as well as combination products.David holds a Bachelor's Degree in Biomedical Engineering and his Masters in Mechanical Engineering. David actually spent 9 years of his career working directly for the FDA as a lead medical device reviewer. After that he spent several years with a med-tech organization called Convatec where he was responsible for developing and growing Global Regulatory and Quality teams as large as a hundred people worldwide, while developing new ways of thinking about Regulatory Affairs for both in market support as well as new product development and a digital transformation.David currently runs a consulting/educational based firm called Mr. Regulatory. The organization really started as an educational platform primarily discussing all things regulatory, guidance documents, things like that on his Youtube channel. He is in the process of growing the content on that channel, but he is also providing consulting services to a variety of start up organizations across the med-tech space when it comes to Regulatory strategy and he is really helping organizations primarily who don’t yet have a regulatory in house force be able to define the right path and gain access to the market.During our conversation, David and I discussed his experiences with the FDA as well as how he decided to start his own show vs working for another organization.Some key highlights we discussed:-What did working for the FDA teach him that was beneficial for working in-industry-What mistakes did he make as a leader that he learned from and is better off because of-What do companies get wrong about Regulatory Affairs? (timing, importance of the function, submission documentation, etc)-What mistakes does he see up and comers, who are striving to be promoted, making along their journey?...and so much more

Ep 7Arvita Tripati- Head of RA/QA Lumonistics- New Age Performance Management
I was joined by Ms. Arvita Tripati, the Head of Quality, Regulatory Affairs and Privacy for a company called Luminostics (Clip Health).Arvita has built a storied career over the last 13 plus years in Regulatory, Quality and Compliance. She’s spent time with recognizable organizations like Coopervision, Accurate, Alivecor and a variety of other companies.Arvita holds her Bachelor’s of Science focused in European Intellectual History and her Masters in Business Administration with a concentration in MarketingLuminostics leverages a patented technology platform which allows for rapid, accurate, infectious disease testing and other health monitoring at the point of care and soon at some point by consumers in their own homes. The unique technology uses a consumer smart phone optics paired with an adapter and the combination of signal processing A/I to detect or measure viruses, bacteria, hormones and proteins with high sensitivity and specificity from samples including swabs, blood, urine and saliva.During our conversation, Arvita and I discussed her leadership philosophies and her views on performance management.Some key highlights we discussed:-What she sees as her responsibility as the leader vs her staff’s responsibility for their professional development-Ideas for performance plans/roadmaps to help staff get where they want to go-How does she strategically identify projects against the professional goals of her staff? (aligning goals to opportunities affording relevant experience)...and so much more!

Ep 6Ankur Kaushal-VP Reg Affairs & Quality -Big Health-Transitioning from large to small orgs
Over the course 14+ years, Mr. Ankur Kaushal has worked in Regulatory Affairs for a variety of the "big players" in the Med-Tech industry like Abbott, Roche, Johnson & Johnson, and Medtronic . He has gained a variety of experience across class II and III medical devices, invitro-diagnostics and digital therapeutics, and he holds his Bachelors Degree in Engineering and Masters Degree in Biomedical Engineering & Regulatory Affairs.Ankur joined me to discuss the key similarities and differences working with very large organizations vs smaller/mid-sized companies.We started off by understanding Ankur's childhood and upbringing and transitioned into understanding how he got involved in the Life Sciences and Regulatory Affairs specifically.Ankur shared so many great insights and make sure to listen to the episode in its entirety, especially if you are one of the "rising stars" trying to climb the leadership ranks in similar fashion to that of Ankur.Ankur Kaushal's LinkedIn Profile:https://www.linkedin.com/in/ankurkaushal/Big Health Website:www.bighealth.com

Ep 5Nick Zweig-AD Talent Acquisition-Beta Bionics-An End to End Candidate Experience
Joining me for this episode was Mr. Nick Zweig, the Associate Director of Talent Acquisition at Beta Bionics based on Concord, MA. Nick eats and breathes Talent Acquisition. It's by no means just a job for him. He is so passionate and enthusiastic about recruitment and helping companies build high performing teams.Nick has been in recruitment, both on the 3rd party search side as well as being the internal champion for several organizations over the last 16+ years. He has worked for major organizations like Fresenius Medical Care as the Manager of Talent Acquisition for the Manufacturing, Quality, and Supply Chain functions.Currently, he is helping Beta Bionics to scale the organization at rapid pace.Beta Bionics is a MA public benefit corporation, and the team is developing a Bionic Pancreas called the Eyelet which is a fully-integrated medical device that is designed to reduce the burden and costs of Diabetes care by automatically and autonomously managing blood sugar levels 24/7 in people with Type 1 Diabetes.During the show, Nick and I discussed the idea of a "Talent Acquisition Experience"Some highlights covered:-When should "Acquisition of Talent" begin? Hint: Before you have an open position-What Place do Job Descriptions Have in 2021?-Employer Value Proposition vs Performance Profile-What is Employer DNA?-Tactical vs Strategic Talent Acquisition (Brand Awareness)Nick Zweig on LinkedIn:https://www.linkedin.com/in/nickzweig/Beta Bionics on the web:www.betabionics.com

Ep 4Lee Lisemby-Vice President Revlar Labs-Overcoming Adversity
Mr. Lee Lisemby, the Vice President at Revlar Labs, joins me to discuss his own personal and professional journey overcoming may challenges that would have caused many others to simply throw in the towel and give up. Growing up Lee faced three challenges, a speech impediment, ADHD, and Dislexia. Rather than getting down on himself, like so many others unfortunately would, he faced his challenges head on and is thriving as a accomplished leader as a direct result.Lee spent 8 years as an enlisted member of the United States Navy. He earned a Bachelors degree in International Business and holds his Lean Six Sigma Black Belt Certification.Over the last 12+ years Lee has held various leadership roles across multiple sectors (including Med-Tech) and even led the Quality efforts for the implementation of a new space suit for NASA used on a Lunar and in a Mars environment. His core competencies are in Supply Chain & Procurement and Operations Strategy utilizing his servant leadership to deliver superior performance and negotiate mutually beneficial vendor relationships.Listen in on Lee's story and the advice he'd share for others facing adversity and wanting more for themselves for their greater future.

Ep 3Dina Justice-VP Regulatory Affairs-Terumo Medical-Women in LifeSciences Leadership
It was a pleasure to host this conversation with Dina Justice, the Vice President of Regulatory Affairs at Terumo Medical. Dina is the epitome of a strong woman in the workforce, but more specifically within the Life Sciences community. During this episode we discuss some of the trials and tribulations Dina endured and overcame both as a single mother and as a female leader who has continued to progress her career to the level of Vice President. She shares some amazing perspective and great insights for women who are trying to find the balance between family and work.

Ep 2Marcelo Trevino-VP RA/QA-Agendia-Top Performance & Performers in RA/QA
Marcelo Trevnio, the VP of Regulatory & Quality at Agendia has built a storied career for himself. He earned his Bachelors Degree in Industrial & Systems Engineer and a Masters Degree in Business Administration. Marcelo also has his Certification in Regulatory Affairs Management and he is a Master Medical Device Auditor through Exemplar Global and is also known as a Biomedical Auditor through ASQ. Over the years, Marcelo has worked his way up the ladder holding various progressive leadership roles at organizations like Medtronic, Nihon Kohden, Applied Medical, and now Agendia.Agendia is the only Molecular Diagnostics company focused solely on breast cancer. The organization uses groundbreaking genomic testing to generate reliable and meaningful clinical data about the unique biology of a woman's breast cancer.During our conversation, Marcelo and I discuss pivotal moments and experiences during his own career journey to-date that helped him achieve his level of success. We also discuss what he looks for when building high performing teams, and several recommendations he has to those aspiring to climb the rungs of leadership themselves.Marcelo Trevino on LinkedIn:https://www.linkedin.com/in/marcelo-trevino-0015921/Agendia:https://agendia.com/

Ep 1Dr Leon Eisen-Founder & CEO-Oxitone Medical-Common Mistakes Startup Leaders Make
Dr Leon Eisen joins us on the very first episode of the Med-Tech Talent Lab to discuss the common pitfalls and mistakes Founders and leaders of start-ups often make.Dr Eisen is the Founder and CEO of Oxitone Medical. Leon has a storied background having successfully launched several Israeli start-ups and is the gentleman who invented the first Wrist Sensor Pulse Oximetry monitor. At his current organization, Dr. Eisen and his team have established a new model of care known as digital continuous care which incorporates modern wearable medical technology and modern AI predictive analytics as a natural evolution of remote patient monitoring.On this first episode of the Med-Tech Talent Lab, we discuss top 5 mistakes start-ups make when organizing AND scaling.Dr. Leon Eisen on LinkedIn:https://www.linkedin.com/in/leoneisen/Oxitone Medical:https://www.oxitone.com/