From Lab to Launch by Qualio

On the podcast today we have David Schoneker who is currently the President of Black Diamond Regulatory Consulting, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries. The firm provides expert advice for difficult problems and training on excipient and food additive regulatory, quality and supply chain concerns. With over 45 years of experience working in these areas, Dave has developed strong networks with trade associations, regulatory agencies and pharmacopeias around the world. He is also an Adjunct Professor at Temple University’s School of Pharmacy in their RA/QA Masters Program teaching courses in Global Excipient Regulations and the Regulation of Dietary Supplements. Prior to this, Dave was the Global Regulatory Director of Strategic Relationships at Colorcon, Inc. Enjoy! Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Dr. Phil Wagner is the CEO & Founder of Sparta Science, a Movement Health Intelligence company dedicated to helping the world move better. Founded in 2014, Sparta Science applies modern data science techniques that advance industry best practices and optimize how organizations assess, understand, and improve health & well-being. With 4 patents, several more pending, and over 20 published, peer-reviewed research studies, Sparta Science continues to advance the Movement Health technology industry. You may not know this but musculoskeletal issues are by far the largest diagnosis in America yet get a fraction of our healthcare budget. This is exactly what Phil and his team is working on - how to optimize human movement and injury risk mitigation. Any of us who have been to physical therapy for example, can learn something new today. Show notes: Sparta Science website Phil Wagner on Linkedin Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Today we have Dr. Jack Hoppin CEO of Ratio Therapeutics and Dr. John Babich Chief Science Officer of Ratio Therapeutics. The team at Ratio Therapeutics is developing a suite of innovative technologies to develop best-in-class targeted radiotherapeutics for the treatment of cancers. They just recently opened a 19,000-square-foot headquarters and R&D facility in Boston to continue their exciting innovation. We’ll dive into how Ratio started, their growth, and what you can learn from their journey from Lab to Launch. Show notes: https://ratiotx.com/ Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Today we have Tony Ulwick on the show. Tony is the pioneer of Jobs-to-be-Done Theory, the inventor of the Outcome-Driven Innovation® (ODI) process, and founder of strategy and innovation consulting firm, Strategyn. He has applied his ODI process at some of the world's leading companies and across nearly all industries to inform breakthrough innovations - achieving a success rate that is 5 times better than the industry average. Philip Kotler calls Tony "the Deming of Innovation" and credits him with bringing predictability to innovation. Published in Harvard Business Review and MIT Sloan Management Review, Tony is also the author of best sellers What Customers Want and Jobs-to-be-Done: Theory to Practice. He is eager to continue sharing insights that will inspire leaders of organizations, executive teams, and innovators to change the way the world innovates. Show notes: https://strategyn.com/ https://www.linkedin.com/in/tonyulwick/ https://www.youtube.com/user/strategyn Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Dr. Linnea Fletcher is a true pioneer at bridging biotech and education. On the show she explains how high school biotech incubators got started and how others can get involved. She also shares more about the upcoming innovATEBIO conference. Dr. Fletcher she simultaneously joined the first National Science Foundation-funded National Biotechnology Education Center, Bio-Link, and received her first NSF-funded Advanced Technological Education grant to start Biotechnology high school programs in Texas. In 2015, she received an Emerging Technology Fund grant to build a Bioscience Incubator at ACC and several Wagner Peyser grants to equip it. Today, the incubator is full of start-up companies and students interning or working for these companies. About innovATEBIO www.innovATEBIO.org InnovATEBIO, the National Biotechnology Education Center funded by NSF (National Science Foundation). The center was funded 4 years ago at 7.5M for 5 years to coordinate over 134 two-year biotechnology programs and their educational partners for the purpose of creating a biotechnology workforce focusing on technician education. Every senior scientist needs 5 to 7 technicians for R&D, biomanufacturing and quality assurance and regulatory matters. (National Science Board report 2019). At the moment, there is not enough technicians being produced to meet the needs of the US biotechnology industry. About Dr. Fletcher https://innovatebio.org/iab-leadership Dr. Linnea Fletcher enjoys all forms of exercise but especially biking, hiking, and swimming. Her favorite pastimes are family events in the outdoors and travel. She received her Ph.D. in microbiology from the University of Texas at Austin, did two postdocs one at the Southwestern Medical Center and another in the Biochemistry Department at the University of Texas. She joined Austin Community College as a Department Chair in Biology and started the Biotechnology Program in 1999. At the same time, she joined the first NSF Funded National Biotechnology Education Center, Bio-Link and received her first NSF funded ATE grant to start Biotechnology high school programs in Texas. She worked as an NSF Program Officer from 2008 to 2010 and was involved setting up the first Vision and Change Meeting. Once back on the job as Biotechnology Department Chair in 2015, she received an Emerging Technology Fund Grant to build a Bioscience Incubator at ACC and several additional grants to equip it. Today the incubator is full of startup companies and students interning or working for these companies. She was PI of the AC2 Bio-Link Regional Center, and is now the PI of InnovATEBIO, the NSF funded National Biotechnology Center. Combining economic development with educational opportunities is her passion. She is also PI and Co-PI on several other grants associated with the work of the center. Linnea Fletcher believes the best way to engage educate students is to involve them in industry projects from high school on –and show them that their education has a purpose and matters—involvement in startup companies does this! Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Dr. Carl Giordano joins us on From Lab To Launch! Carl is the co-founder and Chief Science Officer at Rebesana, a company dedicated to healthy aging and longevity. After years of studying science-backed research on health and aging, orthopedic spine surgeon Carl developed a proprietary supplement to target health on a molecular level. That supplement, backed by scientific publications, delivers a direct signal to cellular pathways in order to maintain health, longevity, and an athletic lifestyle as we age. The secret to slowing aging and extending our lives is closer than we think. Show notes https://rebesana.com/ Biology of Healthspan and Lifespan 40 min version https://youtu.be/CCRzkdEcjHw The Biology of Food Explained https://youtu.be/oa_9opqZ3fY Biology of Healthspan25 min version https://youtu.be/qyLaX_r1Esc Lipids https://youtu.be/vjEKQvu5Al0 Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

We're welcoming a new host to From Lab to Launch! Kelly hands the baton over to Meg Sinclair. Listen in on their conversation about all things podcasting for life sciences, quality and transitioning over the podcast. A little about our new host. Meg has over 10 years of experience in Quality Assurance, Regulatory Affairs and Compliance across a range of industries - from non-profits to medical device start-ups. Like many other Quality professionals who start out in another field or department, Meg found Quality after starting her career in Public Health, but her career path has always been about improving the lives of others which aligns with Qualio’s vision. Meg started with us in 2020 building out our own Quality System to achieve our ISO 9001 certification, followed by ISO 27001 certification in 2022. Meg was also an instrumental part of the Qualio Plus program, where we provide the necessary procedures and advisory level guidance to our customers as they’re coming onboard with Qualio. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Is psychological trauma really just in the mind? Research suggests it isn't. Today we’re interviewing two innovators on the front lines of life sciences and co-authors of a recent book. Dr. Lipov has been called the “Einstein of modern anesthesiology” He’s a renowned board-certified pain specialist and a huge proponent of the stellate ganglion block, a minimally invasive procedure that has been proven effective in treating PTSD symptoms. Jamie Mustard is an artist and a renowned strategic consultant. He is the author of the bestselling book “The Iconist: The Art and Science of Standing Out." Beginning as a child and then into adulthood he suffered years of trauma at varying levels before stumbling across Dr. Lipov and the Dual Sympathetic Reset Procedure or DSR. Today we’re going to dive into their groundbreaking revelation that psychological trauma manifests as a physical injury that can be seen and monitored on a brain scan, and their revolutionary approach to resetting the sympathetic nervous system that has helped countless patients suffering from chronic pain, anxiety, PTSD, and other related conditions. THE INVISIBLE MACHINE: The Startling Truth About Trauma and the Scientific Breakthrough That Can Transform Your Life [April 11, 2023] Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Hypertension affects almost half of all American adults and over 1 billion people globally. Dr. Jay Shah is Chief Medical Officer of Aktiia, a transformative company empowering providers and patients to greatly improve the diagnosis, monitoring, and treatment of hypertension. Jay joined us to share how he plans to tackle this massive problem in public health. More about Dr. Jay Shah Dr. Shah has 15+ years of medical expertise and 11+ years of leadership experience. He has brought his experience and expertise to the Swiss startup Aktiia, to change the paradigm of how the world’s most common disease – hypertension – is understood and managed. Also an angel investor and advisor, he is passionate about applying technology to solve practical problems in medicine and believes strongly in the power of positive thinking and collaboration. Website: www.aktiia.com Social media: @aktiiaglobal LinkedIn: linkedin.com/in/jshahmd Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Today on the show we welcome Dr. Marcus Conant, chief medical officer of American Gene Technologies. Dr. Conant was one of the first physicians to treat AIDS in San Francisco while running the inpatient dermatology service at the University of California San Francisco. Before anyone recognized the virus or understood that it was about to become a global epidemic, Dr. Conant took the lead in forming the Kaposi’s Sarcoma Research & Education Foundation in 1982, which later became the San Francisco AIDS Foundation. He’s dedicated much of his career to fighting for an end to HIV. Full bio Marcus A. Conant, MD Chief Medical Officer at American Gene Technologies Links Marcus Conant, MD, LinkedIn: https://www.linkedin.com/in/marcus-conant-056699229/ American Gene Technologies Website: https://www.americangene.com/ American Gene Technologies LinkedIn: https://www.linkedin.com/company/1127234/ American Gene Technologies Facebook: https://www.facebook.com/amerigene/ American Gene Technologies Twitter: https://twitter.com/americangene American Gene Technologies Instagram: https://www.instagram.com/americangenetechnologies/ Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Today we’re excited to have with us Ernie Wallerstein, Jr., President and CEO of Mental Health Technologies or MHT. Ernie founded MHT back in 2018 and before that spent his career in big and startup tech companies. You can read his full bio in the show notes. Mental Health Technologies is a cloud-based platform for testing and screening patients for behavioral health disorders. It aids professionals in addressing the growing challenge in providing services for mental health and substance abuse. By focusing on ease-of-use for both patients and providers, objective data collection, and enhanced billing practices, MHT’s goal is to horizontally integrate the entire mental health process for healthcare professionals. About Ernie Ernie Wallerstein is of Cuban decent and has over 30 years of executive management and sales experience in software and cloud computing. Prior to founding MHT in 2018, Ernie was the president of Americas, for Enghouse Interactive, a publicly traded telecommunications company. Prior to Enghouse, Ernie Wallerstein held management positions in a tech start-up that went public as well as the SVP of Sales in a $500M+ company that was sold to private equity. Ernie enjoys golfing and spending quality time with his family and friends. But most of all Ernie is proudest of his two sons, Eric who lives in Manhattan and writes for the Wall Street Journal and Nicholas who is a sophomore at Marquette University. https://www.mhtech.com https://www.linkedin.com/company/mentalhealthtech/ https://www.linkedin.com/in/ernie-wallerstein-jr-6906081 Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Today we’re excited to have Dr. Mo Jain, CEO of Sapient. Dr. Jain or Mo as he prefers to be called is a physician-scientist with nearly 20 years of expertise in physiology, biomedicine, engineering, computational biology, and mass spectrometry-based metabolomics. Sapient is one of the largest capacity biomarker discovery labs in the world and well on its way to transform biomedicine forever. For all of our science and bio nerds, you'll sure be fascinated by the insights from Mo. https://sapient.bio/ About Mo Jain - Dr. Jain is a physician-scientist with nearly 20 years of expertise in physiology, biomedicine, engineering, computational biology, and mass spectrometry-based metabolomics. Prior to founding Sapient, he formed and was director of Jain Laboratory at the University of California San Diego (UCSD). There he led a multi-disciplinary research team of chemists, engineers, mathematicians, epidemiologists, and physicians to develop next-generation rapid liquid chromatography-mass spectrometry (rLC-MS) systems to probe the non-genetic landscape of disease across population-scale human studies. His work was supported by the National Institutes of Health Outstanding New Environmental Scientist (ONES) Program grant and over $30M in federal, foundation, and industry funding. Dr. Jain founded Sapient in 2021 as a spinout of Jain Laboratory to expand upon the mission of accelerating human discovery and drug development through the nexus of high throughput analytical mass spectrometry, computational biology, and population-scale clinical studies. As CEO, he develops and directs the organization’s strategy and guides Sapient’s scientific, business, and technical operations. Dr. Jain has held faculty positions at UCSD since 2013, most currently as a Professor of Medicine and Pharmacology. He obtained his MD and PhD from Boston University School of Medicine, and subsequently performed clinical residency and fellowship training in Internal Medicine, Cardiology, and Preventative Cardiology at Brigham and Women’s Hospital, Harvard Medical School. His postdoctoral work was performed at the Broad Institute and Massachusetts General Hospital in the HHMI laboratory, developing methods for large scale, mass spectrometry-based metabolomics and integrative computational analysis to define the role of bioactive metabolites in human disease. https://www.linkedin.com/in/mo-jain-md-phd-373895ba/ Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

There’s no question that 2022 was a tumultuous year for biotech companies. As 2023 is underway, we're talking to Keith Woods, former COO and current strategic advisor on the Commercial Committee of the argenx Board of Directors (from 3/13 on), a biotech company whose strong earnings come amid a downturn for the wider market and especially the biotech industry in 2022. While other companies continue to face challenges in this climate, this biotech is hitting its stride – argenx has managed rapid growth, and a successful drug launch. One major factor driving argenx’s success: argenx’s seasoned COO Keith Woods and his management philosophy of sustainable growth. https://www.argenx.com/ https://www.linkedin.com/in/keith-woods-5b8b67117/ More about Keith Keith is was COO since 2018 and is currently a strategic advisor on the Commercial Committee of the argenx Board of Directors (from 3/13 on). He comes with 25+ years of leadership experience in the biopharmaceutical industry, with the likes of Alexion, Roche, and Amgen. He has sage advice to offer about navigating market downturns, while still managing to grow and scale sustainably. **UPDATE** After recording this interview Keith transitioned from COO to Advisor on the argenx Board of Directors. https://www.globenewswire.com/news-release/2023/03/02/2618906/0/en/argenx-Announces-Planned-Transition-of-Chief-Operating-Officer.html About argenx The team at Argenx has created an antibody innovation ecosystem where pioneering scientists and antibody engineers work side-by-side to accelerate the discovery of novel targets, disease pathways and differentiated therapeutic antibodies. We’ll get more into their discoveries, culture, and how our listeners can bring about innovation by focusing more and more on patients. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

On the show today we have Duane Mancini, CEO & Managing Partner of Project MedTech and proud to be a “nerd” of the MedTech industry. Duane has extensive experience in go-to-market strategy including regulatory & reimbursement, biocompatibility, pre-clinical efficacy testing, and clinical trial design & execution. With all of the complexities of running a Medtech company and taking a product to the market, Duane partners with start-ups to develop strategies and milestones. He runs the Project MedTech podcast series which has over 120 episodes. We’re excited to jump more into the medtech world and what companies need from inception to market. duane.mancini@projectmedtech.com Project Medtech Webpage Project Medtech LinkedIn Duane Mancini LinkedIn Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Chuck Rinker, CEO of PRSONAS, a self-proclaimed Human-AI Innovator, joins the podcast to discuss programming humanity into AI and revolutionizing the clinical trial industry through their iHealthAssist product. Chuck has gone from developing black-ops military tech and NASA/space-borne avionics through gaming to the creation of nuMedia Innovations and the patented technologies behind it including the Digital Personality Engine that brings human engagement to self-service solutions for airports, hospitals, and commercial markets. Listen how this applies to the healthcare and life science industries. https://www.prsonas.com/ https://www.linkedin.com/in/chuckrinker/ More about Chuck My professional career has taken me from developing black-ops military tech and NASA/space-borne avionics through gaming, including directing the NCAA / Madden series of games for EA Sports. This lead to the creation of nuMedia Innovations and the patented technologies behind it. Our premier offering is the PRSONAS™ Digital Personality Engine bringing human engagement to self-service solutions for airports, hospitals, and commercial markets. About PRSONAS Since inception, the team at PRSONAS have worked passionately to implement their vision of a digital workforce - empowering companies and organizations to automate the mundane, freeing time for human innovation. Leading international innovators such as Google for Entrepreneurs, Silicon Valley Open Doors, and FGNoviteiten Juryprijs have recognized us for our efforts. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Today we’re talking to Michael Tarselli Chief Scientific & Knowledge Officer of TetraScience. Mike was the Scientific Director for SLAS, a global professional society dedicated to lab automation and an Associate Director at Novartis building an external scientific collaboration platform. You can read the full bio in the show notes. TetraScience is bringing the future of scientific data to today and has built the largest integration network of lab instruments, informatics applications, CRO/CDMOs, analytics, and data science partners, creating seamless interoperability and an innovation feedback loop that will drive the future of life sciences and the delivery of life-saving therapeutics. More about Mike Tarselli Chief Scientific & Knowledge Officer of TetraScience, Mike Tarselli, explores the Tetra Scientific Data Cloud™ through knowledge capture, GxP compliance, and use case research. Previously, Mike was the Scientific Director for SLAS, a global professional society dedicated to lab automation and an Associate Director at Novartis building an external scientific collaboration platform. Mike received his Ph.D. from UNC Chapel Hill, completed postdoctoral work at Scripps Research, and his MBA through Quantic School of Business & Technology. Show Notes: Tetra Science Website - https://tetrascience.com/Demo of TetaScience - https://www.tetrascience.com/demoBenchmark Data from TetraScience -https://go.tetrascience.com/researchreport_Scientific-Data-Imperative-Establishing-a-New-Benchmark-After-Two-Decades.htmlGXP Solution Brief - https://www.tetrascience.com/solution-brief/gxp-with-tetra-scientific-data-cloudQualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Today we’re talking to Mehdi Maghsoodnia, Co-founder of 1Health which is a personalized precision medicine powered by a lab testing platform that connects labs, clinicians and consumers. Listen to get more details about how 1Health is bringing diagnostic to the modern age. We love the mission of 1Health which is to bring advanced diagnostics to market faster and to make them more accessible, affordable and simple. Love that and it’s similar to our mission at Qualio. About Mehdi Maghsoodnia Mehdi is an industry fellow at UC Berkeley where he teaches innovation and entrepreneurship. He earned his Bachelor's at UC Berkeley and his MS from Stanford with an emphasis in AI and Machine learning. https://1health.io/ https://www.linkedin.com/in/mmaghsoodnia/ Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

What does a modern lab look like? How much manual data processing will take place? Hopefully very little if Ganymede continues to make an impact. Today Nathan Clark, Co-founder of Ganymede, one of the fastest-growing software startups in biotech joins to talk about how to automate and integrate basically everything in a lab. Before Ganymede Nathan was a product manager at Benchling which is another darling startup in biotech we’ve had our eyes on. You can read his full bio in the show notes but we’re excited to have him on today to talk about how the lab of the future will look and much much more. About Nathan Clark Nathan Clark is the Co-Founder of Ganymede.bio, one of the fastest-growing software startups in biotech. Ganymede is the modern, cloud-native, data platform for life sciences companies, and it’s focused on integrating physical lab instruments with digital workflows. Prior to Ganymede, Nathan was the product manager at Benchling for Machine Learning and Insights Analytics. He also has a background in financial technology and trading, and notably launched affirm.com/savings. https://www.linkedin.com/in/nathan-clark-4b850134/ About Ganymede Ganymede is the only whole-lab automation and data integration platform. Connect any lab instrument with any app or pipeline, all in one simple low-code platform. https://www.ganymede.bio/ Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

Dr. Brian Fengler joins us on the show to talk about the latest in healthtech and innovating EHR technology to save lives in fewer clicks. Brian is the Co-Founder and Chief Medical Officer of EvidenceCare (recently named as an Inc. 5000 Fastest-Growing Company), a company that provides a clinical decision support system (CDSS) that’s uniquely integrated with the Electronic Health Record (EHR) to optimize clinician workflows. Dr. Fengler authored a treatment protocol for Pulmonary Embolisms when he was a resident at The University of Virginia. Despite being an expert in the field, he encountered a challenge while treating a 36-week pregnant patient suffering from a massive pulmonary embolism. Like 80% of healthcare decisions, he had to make a snap decision based on a quick internet search. Even though he was able to save both the mother and the unborn baby, he realized there was a gap in evidence-based information available to providers when they need it the most. Looking to fill the gap in 2014, Brian founded EvidenceCare with Co-Founder, Jim Jamieson, to create software that would help physicians make better decisions for their patients and hospital. Before EvidenceCare, he was an Assistant Professor of Emergency Medicine at St Thomas Midtown and Rutherford Hospitals, one of the Founding Physicians and Managing Partners of Physicians Urgent Care, and a partner-owner of the Middle Tennessee Emergency Partners physician group. Dr. Fengler is now revolutionizing decision support at the bedside by providing what clinicians need to give better, evidence-based care. Today, Brian shares more about his journey starting a healthcare tech company, EHR innovation, optimizing clinical workflows, and how the healthcare system can and should be improved. Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez

We've know many who have or had the job title of "Quality Engineer" however many outside the industry may not consider "quality engineers" to be actual engineers in the traditional sense (like mechanical engineering) - Matt Wictome's children think this way. But Matt explains how quality really is an engineering function because processes, products, and companies are being built or fixed—just as a mechanical engineer may build or fix an airplane. Tune into this episode to learn more about how quality can be a central part of meeting patient needs. About Matt and Datod Consulting Matthew P. Wictome, PhD, is Managing Director and founder of Datod Consulting. Datod specializes in building better and more effective Quality organizations. Over the past thirty years he has worked closely with a wide range of companies implementing impactful change to better serve the customer, benefit the shareholder, and improve regulatory compliance. As well as holding qualifications in lean & Six Sigma he is an ISO 13485 Quality System lead auditor. He holds a PhD and graduate degree in Biochemistry and an Executive Masters in Strategy, Change and Leadership with the University of Bristol. He is passionate in designing and implementing quality systems that are effective, efficient and outcome driven. His interests include how organizations function in the real world and the role of organizational culture has on the management of quality. Datod's mission is to be the go-to partner for medical device companies who want to transform their Quality organizations to better serve their patients and grow their businesses. www.datod-consulting.co.uk Qualio website: https://www.qualio.com/ Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show: https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez