From Lab to Launch by Qualio

Qualio

Stories from the front lines of life sciences. Hear how founders, investors, engineers, scientists, and quality experts are innovating to save lives. You’ll hear founders share their insights from launching and scaling their business, investors giving their outlook on funding, industry experts unfolding their latest insights and research, and quality professionals offering advice to navigate the regulatory maze and avoid audit pitfalls. We interview the brightest people in the life sciences industry specifically biotechnology, medical devices, healthcare, pharmaceuticals, software as a medical device (SaMD), contract service providers, and therapeutics. Episodes are about 20-30 minutes. Tune in and leave inspired to bring your life saving products to the world. Passionate about life sciences and want to be on the show? We’d love to chat. Please fill out this short application: https://forms.gle/Yp7uKnSXTCPtTdRcA

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Most likely everyone reading this has been affected by cancer or knows someone who has had cancer.  Using natural cell degradation, today's guest and the team at Arvinas are treating previously undruggable diseases like cancer and Parkinson's. Their goal is to cure cancer or at a minimum, reduce it to a disease where you take your medication and continue living a full life without the terrible side effects of today's treatments.  Dr. Ian Taylor, Chief Science Officer at Arvinas, explains how his team is accomplishing this with PROTAC. Arvinas is a clinical-stage biopharmaceutical company focused on developing new therapeutics for cancers and other difficult-to-treat diseases. If you are hoping for another treatment for cancer besides historical approaches (like chemotherapy), you need to listen to what Dr. Taylor has to say. It's innovating and extremely exciting.  More about Dr. Ian Taylor:Dr. Taylor came to the company after nearly 10 years at Pfizer Oncology, most recently as an Early Development Team Leader. In this role, Dr. Taylor was responsible for leading a cross-functional drug development team that conducted Phase 1 and Phase 2 clinical trials for multiple assets in several cancer indications. His initial role at Pfizer Oncology was as Senior Director of Translational Oncology. In this role, he was responsible for directing translational science activities, which included designing and executing translational research plans and leading companion diagnostic partnerships for programs in both preclinical and clinical (Phase 1 -3) stages. Prior to Pfizer, Dr. Taylor worked at Bayer Healthcare, Pharmaceuticals, holding positions of increasing responsibility, including Vice President of Cancer Biology. In this position, he led the department responsible for all biology aspects of small molecule drug discovery of cancer therapeutics in the mechanistic areas of signal transduction, cell cycle regulation, angiogenesis and apoptosis. During his tenure, the Cancer Biology group delivered numerous molecules to the Development organization. He also started and led the Biomarker group, which contributed to the development of sorafenib. Dr. Taylor earned his B.A. from Bowdoin College and his Ph.D. in Molecular Biology and Genetics from Harvard University. He also completed his postdoctoral training in the laboratory of Dr. Harold Varmus at the University of California, San Francisco and the National Institutes of Health (NIH).Show noteshttps://www.arvinas.comArvinas treatment pipeline: https://www.arvinas.com/pipeline-programs/pipelineBe a guest on the show: https://docs.google.com/forms/d/e/1FAIpQLSeEU7Owi8VDv30hzmWbj4JsXPKyfsWvKXHMeghEAyirAbR18A/viewformMusic by keldez

Oct 28

29 min 59 sec

Today's guest, John Kapitan is the CEO of Kapstone Medical, a company he founded in 2007 after 15 years in the medical device industry as a design engineer and regulatory affairs executive. John is an entrepreneur and expert in medical device design and commercialization.Prior to creating Kapstone, John was a founding member of Altiva Corporation, a spinal implant company that was sold to Exactech, Inc. in 2008. His experience also includes AcroMed Corporation, DePuy AcroMed, and the Cleveland Clinic Foundation.John received his BSME from Cornell University and MBA from the Weatherhead School of Management. He has designed and managed development for dozens of commercialized products, is an inventor on over 20 patents and patents pending, and has authored multiple industry articles. John enjoys spending time on his farm in Asheville, NC with his large family.Insights from the discussion: Don’t sacrifice your best idea for your first idea, spend more time in ideation phase than in the product development cycleHow to make marketing/sales/product and quality the offense and defense strategies of the same teamAs a founder/entrepreneur you need to seek work life rhythm, not balance About Kapstone Medical: The Kapstone Medical Mission is to Inspire, Equip and Guide. Kapstone Medical partners with physician inventors and manufacturers to develop and commercialize new medical devices. We do this by providing services for design, prototyping, patenting, quality systems, and regulatory approvals. Kapstone Medical provides product development, quality management, and project management solutions to clients who value the knowledge, depth of experience, and resources that a highly capable outsource partner has to offer.Show notes:Website: https://www.kapstonemedical.com/LinkedIn: https://www.linkedin.com/in/johnkapitan/John's email: jkapitan@kapstonemedical.com Call Kapstone Medical: (714) 843-7852Be a guest on the show: https://docs.google.com/forms/d/e/1FAIpQLSeEU7Owi8VDv30hzmWbj4JsXPKyfsWvKXHMeghEAyirAbR18A/viewformMusic by keldez

Oct 20

34 min 59 sec

Today's guest, Andrew Breite, Director of Quality at VitaCyte, discusses VitaCyte's contributions to cell isolation and recovery. It's a field that few are as passionate about and dedicated to improving as much as Andrew and VitaCyte. Insights from the discussion: VitaCyte was started to better understand the mechanism by which enzymes work cooperatively to connective tissue and different cells for things like basic cell signaling research, preparing cells for sale, and even clinical therapies like islet transplantation. VitaCyte’s mission is to make reagents more suitable for and compatible for the cells of interest, and to move the overall field forward in terms of understanding how this process work.VitaCyte is different than others because they have a fundamental drive to understand how these reagents work, and how they will ultimately contribute to the quality of the cells that are recovered for specific applications. About Andrew Breite:Andrew was originally trained as an analytical protein biochemist. His professional roles have focused primarily on purification process optimization, assay development and product development. Andrew now serves as the Dir of Quality Assurance for a purified enzyme reagent product portfolio at VitaCyte. He has served in numerous roles during his more than 10 years at VitaCyte and helped develop the quality management system from the ground up.About VitaCyte: VitaCyte’s co-founders, Bob McCarthy and Francis Dwulet, were key contributors to the development of the first commercial, purified collagenase-protease enzyme mixture used to prepare cells for subsequent transplantation. This improved tissue dissociation enzyme reagent contributed to success of the “Edmonton Protocol,” the first report of successful treatment of adult patients with Type 1 Diabetes where 7 of 7 patients were “insulin independent” one year after islet transplantation. Prior to the introduction of this purified enzyme reagent, most laboratories performing this clinical research procedure were spending significant amounts of time qualifying collagenase lots for their effectiveness to isolate human islets. Once a lot was selected, the lot qualification procedure was repeated within a year, often because of the instability of the enzymes in storage.VitaCyte was initially funded by receiving NIH NIDDK Small Business Innovation Research (SBIR) awards, a state of Indiana 21st Century Fund award, and several state of Indiana SBIR matching awards.The VitaCyte team’s curiosity about improving the state of cell isolation/recovery leads us to seek new solutions that reflect our mission to manufacture and support product/services that improve customer productivity. We encourage dialogue with our users who, in turn, stimulate us to develop new or improved products; to collaborate with lead users to develop a deeper understanding of how enzymes release cells from the extracellular matrix; and to engage others at scientific meetings to discuss their concerns about using enzyme to recover cells from tissue or after in vitro culture.Show notes:Website: https://www.vitacyte.com/LinkedIn: https://www.linkedin.com/in/andrewbreite/Edmonton Protocol: https://www.sciencedirect.com/topics/medicine-and-dentistry/edmonton-protocolBe a guest: https://docs.google.com/forms/d/e/1FAIpQLSeEU7Owi8VDv30hzmWbj4JsXPKyfsWvKXHMeghEAyirAbR18A/viewformMusic by keldez

Sep 22

18 min 14 sec

Typically, it takes several months for third-parties and consultants in the life sciences industry to get data back to pharma companies with payer research. Today's guest is Baiju Aurora, CEO of Market Access Transformation (MAT) is shrinking getting payer response research to a few days. Baiju has led the MAT team for more than five years and their first product, Rapid Payer Response, provides pharma companies payer research in only a few days from their payer network. Baiju’s career has spanned pricing, market access, health economics, and outcomes research for bio pharma, medical device, and diagnostics companies.Key Takeaways:Embrace unexpected clientsIndustry trends in pharma, including consolidation, execution, and how faster market research can propel pharma companies forwardConsider building a company with profitability first in mind rather than scale and growthShow Notes: Market Access Transformation (MAT) - Rapid Payer ResponseBaiju Aurora on LinkedInThe Physician Payments Sunshine ActFood Safety Preventive Controls Alliance (FSPCA)General Data Protection Regulation (GDPR)European Pharmaceutical Market Research Association (EphMRA)U.S. Food and Drug Administration (FDA)Application to be on the show: From Lab to LaunchQualioMusic by keldez

Sep 15

35 min 1 sec

To be truly successful, quality must go beyond just meeting compliance requirements. When quality is a core practice at a company, everyone from the end patient to the investors benefit. A Harvard study on quality found that a “company with a highly developed culture of quality spends, on average, $350 million less annually fixing mistakes than a company with a poorly developed one.” In this episode 5 quality management experts who work closely with entrepreneurs and startups discuss how to define a quality culture at your company and help everyone on your team strive to improve it. Guest in the discussion are:Meg Sinclair, Sr. Quality Specialist at QualioLaura Araujo, VP of Quality at 4G ClinicalKelly Stanton, Dir. of Quality at QualioDevon Campbell, Founder of Prodct LLCChristie Johnson, Founder of Kasota Engineering LLC (recently joined Product)The content for this episode comes from a webinar about quality culture. A link to the full webinar can be found below. Show Notes: The Quality Culture Playbook: How to build a quality culture (full webinar)Prodct LLC4G ClinicalApplication to be on the show: From Lab to LaunchQualioMusic by keldez

Aug 25

40 min 22 sec

Mental health issues have been on the minds of many as athletes are under tremendous pressure to perform perfectly at the Olympics, and Filament Health is on a mission to get safe, natural psychedelics into the hands of everyone who needs them as soon as possible. Today's guest is Ben Lightburn, CEO and Co-Founder of Filament Health, an exclusively natural psychedelic drug development company. Ben talks about rapidly discovering and extracting natural pharmaceuticals. Ben is an entrepreneur specializing in the research, development, and commercialization of novel extraction technologies. He applies his background in botanical extraction to this emerging class of medicines. Filament Health is building a platform to support the treatment of mental health conditions through GMP-compliant and FDA-approved psychedelic extracts from lab-grown and regeneratively harvested plants. Key Takeaways:Insights on building a core team comfortable with operating in a startup environmentApproach to patenting and clinical trial process, as well as regulations for psychedelicsCommon misconceptions about natural pharmaceuticalsShow Notes: Filament HealthFilament Health - About UsFilament Health - Our TechnologyGood Manufacturing Practice (GMP)U.S. Food and Drug Administration (FDA)FDA - Breakthrough TherapyU.S. Drug Enforcement Administration (DEA)Health CanadaMazza InnovationApplication to be on the show: From Lab to LaunchQualioMusic by keldez

Aug 4

28 min 31 sec

Have you ever wondered why so many new biotech companies don't survive the first valley of death, which is the launch? Very likely it's the lack of access to labs, specialized equipment, advisors, and resources. Today's guests Shawn Carbonell, MD, Ph.D., and Brent Witgen, Ph.D., co-founders of Brazen Bio. Recently, Brent and Shawn launched Brazen Bio to help biotech founders advance human health. Brazen Bio is building a turnkey incubator program with state-of-the-art laboratory access, including specialized equipment, technical support, expert advisors, and housing accommodations.Based in Los Angeles, Brent and Shawn are planning to run the first cohort of founders through the accelerator incubator program this year.Key Takeaways:Biotech startups fail due to unmet needs; Brazen Bio can help resolve those needs for biotech foundersBrazen is actively recruiting underrepresented founders with a goal to launch 100 companies in the next 10 years. Access to state-of-the-art equipment, labs, and advisors should enable more startups to and innovation in the industryFirst cohort for Brazen Bio is this year. Show Notes: Brazen.bioEmployees at Brazen BioInvest in Brazen BioBioLabs LA at the Lundquist InstituteWeWorkIndieBioY CombinatorAmazon Web Services (AWS)StripeHubSpotApplication to be on the show: From Lab to LaunchQualioMusic by keldez

Jun 29

19 min 13 sec

Today’s guest is Rob Crowder, Head of Product at Nutromics in Australia, which has a booming life science community. Nutromics is a medical device company with a hardware and software component that includes a wearable micro-needle biosensor and software companion. Nutromics’s vision is a world with zero preventable deaths due to a lack of timely biological data, and it’s mission is to revolutionize health care through real-time molecular monitoring. Maybe one day, everybody will be wearing biosensors and have real time data from a molecular-level information superhighway.Rob is a former GM of a Medtech product development company and has worked with more than 100 companies on feasibility, design, and commercialization of novel products. Key Takeaways:How to approach the challenges of developing hardware and software productsHow to have the right mindset as a product leaderHow to balance quality and product development velocityShow Notes: NutromicsApplication to be on the show: From Lab to LaunchQualioMusic by keldez

Jun 23

17 min 54 sec

Today’s guest is Dr. Heather Underwood, CEO of EvoEndo. She talks about launching the first unsedated single-use endoscope to market.Heather joined EvoEndo in 2019 after completing the Stanford Biodesign Fellowship for medical device innovation. She completed her PhD at the University of Colorado (CU) - Boulder's ATLAS program, where she developed and implemented clinical decision support systems for midwives and nurses in Kenya, receiving the NSF Graduate Research Fellowship Grant and Gates Grand Challenges Grant to support her research. Heather has spent the past 10 years founding and leading medical device startups, non-profit life science organizations, and innovative academic initiatives, including co-founding Inworks at CU Denver.EvoEndo was co-founded in 2017 by Dr. Joel Friedlander, a pediatric gastroenterologist, and the interdisciplinary aerodigestive medicine team at Children’s Hospital of Colorado. EvoEndo’s mission is to make endoscopies safer for patients by eliminating the need for general anesthesia while reducing the complexity and cost of endoscopy for physicians and hospitals. EvoEndo’s system combines sterile, single-use, flexible endoscopes with virtual reality (VR) based patient distraction to allow the procedure to be performed safely in children and adults without anesthesia or sedation. Key Takeaways:How EvoEndo’s products allow for more frequent monitoring and faster results for patients and healthcare providersTips for the journey on FDA submissionsHow to fundraise while building relationships and trust with your investors Show Notes: EvoEndo Website EvoEndo on LinkedIn Dr. Heather Underwood on LinkedIn EvoEndo Raises $10.1 Million to Make Unsedated Transnasal Endoscopy a Reality for Patients and Physicians FDA - 510(k) Submission ProcessApplication to be on the show: From Lab to LaunchQualioMusic by keldez

Jun 16

15 min 42 sec

Today’s guests are Greg Yap and Jean-Paul (JP) Sanday from Menlo Ventures where fundraising is the #1 priority for almost every founder in life sciences.Menlo’s 5 P framework for investing: Program, Platform, Portfolio, Partnerships, and People. Greg invests in teams trying to solve major problems in life science and health care, with a special interest in novel therapeutic platforms, digital health, and transformative technologies. JP focuses on vertical SaaS and enterprise software. He is excited about the future of work, infusing lives with intelligent automation, and democratizing data analytics. JP’s favorite part of his job is partnering with passionate founders to build a business that matters. These relationships are informed by JP’s own experience as an executive in hyper-growth companies, where he learned the critical role that culture plays in setting up a company for success. His conversations often focus on the “job” a product is hired to do, and he firmly believes customer retention is the best way to build a lasting company.Key Takeaways:Founders: Know the difference between a platform company and product companyCapital: If you want to raise capital, approach investors in an altruistic and human wayValue Chain: Life sciences has evolved and the future outlook of regulated industries is how most countries adopt the most-stringent regulationsShow Notes: Greg YapGreg Yap’s EmailGreg Yap on LinkedInJP SandayJP Sanday’s EmailJP Sanday on LinkedInMenlo Ventures Sparta SystemsRocheFDA - Classify Your Medical DeviceEuropean Union - Medical Device Regulation (EU MDR)BenchlingRecursion PharmaceuticalsCofactor GenomicsApplication to be on the show: From Lab to LaunchQualioMusic by keldez

Jun 3

33 min 56 sec

Today’s guest is Kristinn Gylfason, Compliance Officer at Sidekick Health and a lawyer who specializes in privacy.Sidekick Health was founded by two doctors, who worked for years treating patients with lifestyle-related illnesses. They explored ways to prevent chronic illnesses, help patients manage them, and improve their quality of life. Sidekick Health combines strong clinical validation with gamification, behavioral economics, and artificial intelligence (AI) to deliver engaging and personalized patient experience.Previously, Kristinn worked as a consultant focusing on General Data Protection Regulation (GDPR) before joining Sidekick Health in November 2019. Since then, he has focused on registering Sidekick Health as a manufacturer of medical devices. In doing so, Kristinn has gotten involved more with quality matters. Sidekick Health’s platform is rated in the top 0.1% in quality by ORCHA, which has more than 30,000 users and clinical validation and successful customer launches across multiple therapeutic areas – ranging from type 2 diabetes to ulcerative colitis.Key Takeaways:How to enter new marketsWhy quality is important for Software as a Medical Device (SaMD) companiesHow to scale your business while keeping culture top of mind Show Notes: Kristinn Gylfason on LinkedInSidekick HealthGeneral Data Protection Regulation (GDPR)FDA - SaMD FDA - Classify Your Medical DevicePfizerORCHAeHealth Award 2020No Rules RulesApplication to be on the show: From Lab to LaunchQualioMusic by keldez

May 27

22 min 9 sec

Today’s guest is Lisa Helmonds, Vice President of Quality Services and Operations at MWA Consulting, which helps companies bring life-saving products to market and scale successfully. Lisa has more than 30 years of training in the areas of manufacturing and quality assurance for the pharmaceutical, biotechnology, and medical device industries. Also, she has extensive "good practice" (GxP) knowledge of quality guidelines and regulations. She works with several startups and established companies to implement or improve quality systems and procedures.Lisa understands the challenges that industries deal with today. She describes a day-in-the-life of a quality consultant, innovations, and advice to life science entrepreneurs everywhere. Lisa has seen it all and offers some useful takeaways from her insights. Show Notes: Lisa Helmonds on LinkedInMWA ConsultingBioMarinGenentechU.S. Food and Drug Administration (FDA)FDA - Form 483 Warning Letter or Inspection ObservationFDA - Guidance DocumentsApplication to be on the show: From Lab to LaunchQualioMusic by keldez

May 19

19 min 18 sec

Andy Levien, President and CEO of ArcScan talks to Robert about expanding his medical device company internationally and into China.  ArcScan was founded in February 2007 in Golden, Colorado. Their product, the ArcScan Insight® 100 is the leading, very high frequency ultrasound device that images the entire anterior segment of the eye, including behind the iris; areas that cannot be seen with even the newest models of optical technologyAnd because the system is not handheld, diagnostic measurements have never been this precise. ArcScan’s many innovations have led to a number of issued and pending ArcScan patents. Due to the success of accommodating intra-ocular lenses and the ever-growing refractive surgery market, intelligent imaging and precise measurements are more necessary than ever before. Show notes:https://arcscan.com/https://www.linkedin.com/in/andrewlevien/ About AndyAndy Levien was appointed President and CEO of ArcScan in April 2012, and currently holds this position today. Before that he served as President and Global VP Operations of Norgren and President of Norgren Fluid Controls, a pneumatics and industrial controls company. Prior to that he held SVP and General Manager roles at Emerson Electric Co., an electrical equipment  and industrial instruments manufacturer. ArcScan was founded in February 2007 in Golden, Colorado. The original machine, the Artemis 2, was eventually rebranded and became the ArcScan Insight® 100. The ArcScan Insight® 100 is the leading, very high frequency ultrasound (VHFU) device that images the entire anterior segment of the eye, including behind the iris; areas that cannot be seen with even the newest models of optical technology. And because the system is not handheld, diagnostic measurements have never been this precise. ArcScan’s many innovations have led to a number of issued and pending ArcScan patents. Due to the success of accommodating intraocular lenses and the ever-growing refractive surgery market, intelligent imaging and precise measurements are more necessary than ever before.Apply to be on From Lab to Launch here.Music by keldez

May 12

21 min 5 sec

Dr. Amy Beckley, founder and CEO of MFB Fertility and inventor of the Proov fertility test joins the show to talk about her journey as a scientist going through infertility herself to searching for answers and inventing a solution.   Amy Beckley, had trouble conceiving for over three years, she did what many women do: saved up thousands of dollars and pursued in-vitro fertilization treatment. After being blessed with a son, Amy knew she wanted to continue to grow her family. What she didn’t know was how well she could handle the physical and emotional challenge of another round of IVF. With a PhD in Pharmacology and expertise in hormone signaling, she began tracking her own hormone levels at home. In doing so, she started to suspect that she had a problem with ovulation —which was causing her to lose pregnancy after pregnancy. Empowered by this knowledge, she went to her doctor and got a prescription for hormone supplements. With these supplements, she was able to conceive without the help of IVF, and maintain a healthy pregnancy. After her daughter was born, her mission was clear—to empower women with vital knowledge that could help in their ability to conceive. She founded MFB Fertility, Inc. and invented the Proov test in her own basement, which now allows women to confirm successful ovulation by tracking PdG in just five minutes, at home. Show notes:https://proovtest.com/https://www.forbes.com/sites/alicebroster/2020/07/02/air-force-invests-13-million-to-help-military-couples-conceive/?sh=2df266de4cb3https://www.linkedin.com/in/amybeckley/https://www.today.com/video/how-the-pandemic-is-impacting-family-planning-and-ivf-102026821986https://www.titan100.biz/amybeckleyMusic by keldez

Apr 27

17 min 31 sec

Today we're excited to have Laura Araujo, Vice President of Quality at 4G Clinical share her insight into quality management. 4G Clinical’s focus and mission is to bring crucial medicines to those who need them faster. 4G Clinical delivers modern, flexible and validated randomization and trial supply management solutions to Pharma and CROs faster than anyone else in the world. Laura has over 30 years of experience in Quality Assurance and Technology, holding various positions in Software Development, Quality Assurance, Software Auditing, and Technology Management. She has had positions in, or related to, the pharmaceutical industry for 25 years, including owning and running her own consulting firm for 10 years. During our conversation today, we talk about 4G Clinical and what they have accomplished, especially during the pandemic, Laura’s experience of working as a consultant, switching career paths and entering the Quality space, and much more!Show Notes:https://www.4gclinical.com/homeLaura Araujo on LinkedInMusic by keldez

Apr 21

20 min 27 sec

Today we welcome Mr. Assaf Barnea to the show. He is a former pro basketball player in Europe and currently the CEO of Sanara Ventures, a healthcare innovation fund backed by Phillips and Teva Pharmaceuticals investing in digital health and medical device technologies.Sanara invests primarily in early stage digital health and bio convergence companies. He offers his insight and outlook on bio convergence in the future.Assaf also shares experiences as the co-founder of the World Bank’s International Finance Corporation’s Tech Emerge Initiative, which is a unique acceleration platform that connects healthcare startups from around the world with leading corporations and hospitals in emerging economies. He talks about the work done in India, Brazil, and now Africa. Truly inspiring and life-changing work. In his career, Mr. Barnea co-founded CardioSense, a medtech startup company, served as CEO of Kinrot Ventures spearheading its acquisition by Hutchison Water in 2012. He spearheaded business development at Mekorot, Israel’s national water company, where he oversaw the establishment of WaTech, the Entrepreneurship & Partnership Center for Water Technologies, where he received the Cleantech Group’s Innovation Hero Award.A unique highlight in Assaf’s story is basketball. At New Jersey’s Seton Hall University he and his team won the Big East championship against Georgetown in 1991 playing against Dikembe Mutombo and Alonzo Mourning. He played professionally in Europe for years and shares some parallels between athletic prowess and entrepreneurship.We’re excited to have him share his perspective and advice for entrepreneurs on today’s show.Show Notes:www.SanaraVentures.comhttps://www.techemerge.org/Assaf on LinkedInMusic by keldez

Apr 14

17 min 56 sec

It only takes one ground-breaking MedTech startup to change a product category forever. Back in 2006, serial entrepreneur Steve Kelly partnered with MIT researchers to take an anti-bleeding gel product to market. The biodegradable gel was a significantly better option for many hemostat applications, compared to alternatives like bandages, surgical clamps, tissue adhesives, vasoconstrictors, and cauterization. Today, topical hemostatic agents are considered the most efficient, effective, and safe option to stop bleeding in many patients and conditions.Winning medical device startups have a few factors in common, according to McKinsey research. First, they all have an idea that can provide consistently superior experiences to all users, including patients, caregivers, and clinicians. They will also “reimagine processes to dramatically reduce costs and accelerate decision making.” The most successful MedTech companies manage to get closer to the patient by providing an innovation that’s better, cheaper, safer, more convenient, or somehow just a better option.In order to get close to the patient, MedTech startups need to achieve velocity in the early stages to provide proof-of-concept, secure funding, and demonstrate clinical safety for regulatory approval. There’s no room for mistakes or delays in a hyper-competitive market space. A strong baseline of compliance is crucial from day one to ensure there are no barriers to obtaining FDA approval or a CE Mark.That's one of the reasons we exist. Qualio is quality management software for the life sciences ecosystem. ABLE HUMAN MOTIONDAY ZERO DIAGNOSTICSGARWOOD MEDICAL DEVICESX-COR THERAPEUTICSFLATIRON HEALTHIf you can think of any other innovative companies that we should feature on from lab to launch, Let us know by filling out this form:https://docs.google.com/forms/d/e/1FAIpQLSeEU7Owi8VDv30hzmWbj4JsXPKyfsWvKXHMeghEAyirAbR18A/viewformSee interviews and episodes on https://www.qualio.com/from-lab-to-launch-podcast.Music by keldez

Mar 31

9 min 9 sec

What if incurable diseases like HIV, cancer, PKU, and epithelial solid tumors were completely curable? We're closer than you might think. Really close. In fact, Jeff Galvin and his team at American Gene Technologies™ (AGT) have been advancing the research and application of viral vectors for several years with some incredibly exciting breakthroughs on the horizon (hint: curing HIV could be just a few years away). In case you didn't know already, viral vectors is a relatively new technology where you can crack open any virus, scoop out the malevolent code and replace it with code to attack the root drivers of what are today incurable diseases. Essentially this creates a "stealth bomber" benevolent virus in your body. The future of this treatment could "send radiation and chemotherapy the way of bloodletting and leeches" as Jeff says in this podcast. Jeff has a contagious energy for gene technology and a grand vision of the future of curing the incurable.If you want to get a peak at how gene technology could quite literally change the world (and soon!) listen to what Jeff has to say.Enjoy!About Jeff GalvinJeff Galvin is the CEO and Founder of American Gene Technologies™ (AGT). He earned his BA degree in Economics from Harvard in 1981 and has more than 30 years of business and entrepreneurial experience including founder or executive positions at a variety of Silicon Valley startups. Several of his companies were taken public and/or sold to public companies, including one in the medical-technology arena that was sold to Varian, the leading maker of linear accelerators used in cancer therapy. Following his startup experience, he retired to become an Angel Investor in real estate and high tech. He came out of retirement to found and fund AGT after meeting Roscoe Brady at NIH.Show notes:Jeff's LinkedInJeff on Twitter: @jeffreygalvinhttps://www.americangene.com/Press Release about AGT's FDA approval to continue HIV cure programAGT on LinkedInAGT on Twitter - @americangeneAGT on Facebook - @amerigeneAGT on Instagram - @americangenetechnologiesMusic by keldez

Mar 25

26 min 3 sec

Over $50B (with a B!) is available each year to life science companies from federal agencies. The best part is, it's all non-dilutive funding. For example, the NIH's Small Business Innovation Research (SBIR) program alone awards $1B each year. That's more annual funding than any VC! And that's just one of many SBIR programs available from US Federal agencies. Ram May-Ron, managing partner at FreeMind Consultants walks through the enormity and approachability of these federal non-dilutive programs. FreeMind Group helps life science organizations secure non-dilutive funding from US federal agencies and private foundations.FreeMind started in 1999 and has grown into the largest consulting group of its kind. With experience in seeking funding from nearly all NIH Institutes, Department of Defense, NSF, FDA, BARDA, etc., as well as private foundations, they’ve helped clients garner over 1.5 billion dollars to date. Awards range from $150,000 to $150,000,000 per project. If funding is on your mind - you need to consider what Ram has to say here. Show notes:https://www.freemindconsultants.com/Ram on LinkedInNIH.govMusic by keldez

Mar 17

20 min 31 sec

Imagine if Stephen Hawking couldn't communicate. The world's understanding of theoretical physics would be greatly limited. There are roughly half a billion people like Stephen Hawking who are just waiting for an awakening. They could communicate and contribute if they only had the technology to do so. Helping these people with either motor or cognitive limitations be able to communicate is part of the big mission of Andreas Forsland, Founder and CEO at Cognixion. Andreas has a robust background in hardware, software, and design. That background all converged when his mother was in the hospital struggling to communicate to healthcare providers. The idea for Cognixion was then born. Cognixion is a digital health startup based in Santa Barbara, California and Toronto, Ontario. Cognixion builds accessible and affordable neuroprosthetic software and wearables that use biometric sensors and machine learning in new ways to help people with complex disabilities use their face, eyes and brain as a direct control interface for mobile and augmented reality accessibility. Imagine controlling Alexa with your brain. Mind blown!Cognixion is the "Tesla of Neurotech" and is recognized as a top 21 neurotech startup to watch, and is focused on scaling up the transformation of over 100 million lives and translating universal design approaches for everyone by focusing on the most challenging human interaction needs. Show notes:Andreas on LinkedInwww.cognixion.comCognixion Press KitMusic by keldez

Mar 10

20 min 58 sec

Today, we're introducing a new type of episode called Quality Quick Tips.  Periodically we'll focus on specific aspects of quality management since we love to nerd out on all things quality and compliance. Call us weird. Call us what you want, but quality management is what we love to do. And we do it well ...so why not have some fun along the way! Today, two of Qualio's QA experts, Kelly and Ezra talk about how to maintain and improve your quality management while working remotely. It was a conversation that they had in the midst of the COVID 19 pandemic, but it still applies today.  As many organizations are still adjusting to a new normal of remote quality work, they cover important aspects like what questions to ask to better evaluate and prioritize tasks, the what and how to communicate about quality issues, how to manage remote audits, the importance of documentation all of these changes that are happening. Internal and external factors and a lot more. Building and improving a culture of quality at your company can be done either remote or in person, and this episode can help you show how that's done. Music by: keldez

Mar 3

22 min 24 sec

Cables are everywhere, quite literally. Quality management for a cable testing company can be challenging, especially with continuous audits from partners, but Gene Vought makes it look easy. Gene is a quality manager at Cirris and has been with the company for over 25 years. Cirris designs manufacturers, worldwide sales, service, and technical support for cable testing equipment for manufacturers of cable assemblies, wire harnesses, custom fixtures, and other interconnection products. Ambition and a desire to serve customers have placed cable testers in the hands of thousands of customers on every continent, even including Antarctica. People all over the world rely on Cirris when they test cables that helped drive cars, heal patients, defend soldiers and even launched satellites into space. Gene has an impressive track record and background, and we're really excited to have the opportunity to speak with him today. I think you'll really enjoy this episode because we talk about his experience in the aerospace industry,  his experienced at Cirris and the life sciences industry and his role as a quality manager and how important that is to the success of the company. Also kind of fun what he enjoys to do outside of work. Hope you enjoy.Show notes:https://www.linkedin.com/in/gene-vought-57196b20/https://www.cirris.com/http://www.genevought.com/ Music by keldez

Feb 24

19 min 54 sec

Did you know about $6 billion is spent each year in medical device recall management? Having a product recall is probably a medical device companies, worst nightmare, but once something gets recalled, the communication between the FDA and manufacturers and healthcare facilities, all involved in the workflow of that product ,often break down or are slow to respond. This results in patients becoming highly at risk.  To solve this, Joan created Xcelrate UDI with a goal to improve patient safety at the point of care, by leveraging the power of the unique device identification system for medical devices and biological tissues.  Xcelrate UDI uses innovative barcode scanning technology to capture the data required by the FDA and digitally document. The patient health record with precision and accuracy. Joan has over 25 years building and optimizing healthcare applications specializing in perioperative, anesthesia, and trauma workflows. She shares some great insights with us today by starting a couple of, with a big mission. And it was an 800% increase in recalls in recent years, a byproduct of companies increasingly moving faster in this space over time, there has never been a more important time than now to focus on quality and alerting and patient safety. Show notes:https://www.xcelrateudi.com/https://www.linkedin.com/company/xcelrate-udi/Music by keldez

Feb 17

23 min 27 sec

Getting funding and scaling a medical device business alone is challenging. But challenges don't deter entrepreneurs like Jen Baird. From being disregarded at first from VCs  simply because she was a woman, to then selling her company for $205M,  to today scaling a med device startup with a denovo FDA application, Jen has done it all! If that's not impressive enough, she takes time to write her insights as a startup CEO in her personal blog. Jen has founded and led multiple healthcare ventures. Her most successful company to date was Accuri Cytometers which Jen led from inception to global commercialization. She raised over $30 million in angel and venture capital financing, developed a product and achieved more than $12 million in annual sales in just five years. In 2011, Accuri was sold to Becton Dickinson for $205 million, which is a 10X revenue multiple and Jen generated, or a 5X return for her investors. Most recently, Jen raised an $11.5 million Series A to found and build Fifth Eye, a medical device software company that detects hemodynamic status from a single streaming lead of ECG. Her career also includes stints in commercial banking, management consulting, and several other previous startups. Jen graduated at the top of her class with a master's in management, from Northwestern University's Kellogg graduate school of management and earned a BA in organizational psychology from the University of Michigan. For everyone who's listening and in the trenches of building a life sciences company, Jen has been there many times and has had some incredible exits. I hope you enjoy listening and learning from her wisdom and experience. Show notes:www.FifthEye.comJen's LinkedIn: linkedin.com/in/jenbairdJen's blog:  www.StartupCEOReflections.com Music by keldez Jen's Photo credit Leisa Thompson

Feb 10

26 min 42 sec

Did you know nurses are required to turn and change bed-bound patients every two hours?  The primary reason for this protocol is to help patients avoid pressure ulcers. At first glance, that seems like a straightforward and quick task. But it's actually quite a challenge, especially when nurses are short-handed. The traditional approach of turning patients is time consuming and prone to injuring nurses. The problem has serious financial healthcare costs as well with $250 billion spent each year on nursing injuries and pressure ulcers. Charleen Solomon, a nurse herself, thought of a solution one day when her sweater got caught in the door of her car. Her back was aching from turning a hospice patient that day and her 2nd shift was about to start when she had a lightning moment of inspiration to what would lead to her Q2 Solution. Charleen shares her journey from prototyping with fellow nurses, selling her house to have capital, seeking investment (and being rejected 200 times), to finding the right manufacturer, to a very successful product today with contracts with some of the biggest in healthcare. She knew the product worked from first-hand experience. Her tenacity, purpose, and gratitude are inspiring for any entrepreneur starting their own life science company. Notes:ariseq2.comCharleen on LinkedInMusic by keldez

Feb 2

23 min 36 sec

Gillian Berry is a qualified clinical nurse specialist and founder of PerCen Technologies. She founded PerCen Technologies in response to challenges she felt were not addressed in Healthcare. It’s aim is to use scientific knowledge and the latest technologies to compliment clinical evidence based practice. PerCen Technologies is supported by the first national Health Innovation Hub of Ireland. We love seeing healthcare innovation coming out of Ireland, so we had to talk to Gill.  ;) Gill shares her takeaways after co-founding one of the first open source efforts in response to the Covid19 pandemic, the Open Source ventilator project and the Open Source Volunteers Extended network. She managed over 1,000 STEM  professional volunteers, academic institutions, SME’s and Multi-National’s and facilitated 30 projects with a transfer of knowledge and skills. It’s amazing what can be accomplished when we network, open source ideas, and collaborate together. Gillian’s story and lessons learned about the power of a network are certainly inspiring and applicable today. Enjoy! Show noteshttps://www.teamosv.com/osvx/Gill's LinkedInMusic by keldez

Jan 27

27 min 57 sec

For the first time in healthcare, human ambition and technology are starting to intersect and AI is one of the main drivers. Listen in on this episode with Sam Dribin to learn about how AI is evolving to improve healthcare results.  Sam Dribin is the Chief Technology Officer for CureMetrix, an AI company focused on solutions that support radiology.Sam has a diverse background in technology including Biotech software development with expertise in the technical issues facing healthcare and life science companies and laboratories.For the last five years, he’s been on the forefront evolving artificial intelligence with solutions that are focused on AI-based mammography to improve cancer detection. We’ve known Sam and CureMetrix for some time as a customer of Qualio, but today he shares his insight into how AI can impact healthcare such as reducing false-positives and increasing access to healthcare everywhere.Show notes: https://curemetrix.com/Sam Dribin's LinkedInRadiology Society of North AmericaMusic:keldez

Jan 20

21 min 46 sec

The story behind HAI Solutions is so inspiring and similar to many life science entrepreneurs who start their companies after personal (and occasionally tragic) experiences.Nick Perrenoud is one of those entrepreneurs. He's the co-founder of HAI Solutions and led the development and patent for a solution to protect patients from the accidental or negligent contamination of IV anesthesia medications.Nick learned the importance of protecting patients with sterile IVs, not only as a nurse anesthetist, but also when caring for his adopted son who required IVs for seven years and spent nearly three years in the hospital to, to central line infections. He shares many useful insights for any medical device entrepreneur such as how securing patents has helped with fundraising, focusing on your purpose, and being patient-driven. Enjoy!Show notes: https://www.hai-solutions.com/HAI Solutions StoryNick Perrenoud's LinkedInMusic:keldez

Jan 13

24 min 51 sec

Listen to this chat between Qualio CEO, Robert Fenton and Claire Bonaci from Microsoft about how the life science industry is evolving.  We cover a wide of topics and trends based on her expertise and how she aspires to inspire young women interested in STEM and leadership roles. Guest Bio:Claire currently serves as Sr. Director of the Pharma sub vertical of the US Health & Life Sciences department at Microsoft. She works in partnership with US life science companies, pharma, and health organizations to create innovative Microsoft solutions specific to the company’s issues affecting their patients and their business.She brings with her an expertise in the clinical trial and pharmaceutical industry, having been a global study lead on oncology clinical trials at a large pharmaceutical company prior to joining Microsoft. She has deep understanding of the clinical trial value chain and the complex nuances that biotechnology and life science companies experience. She is passionate about the many services and innovations Microsoft has to offer to reduce time to market for new drugs and provide better outcomes to patients.Claire is also the producer and host of the Confessions of Health Geeks podcast, an industry focused podcast on the biggest trends and pain points in health and life sciences. Claire also has a passion for inspiring young women to be interested in STEM and leadership roles in STEM related fields. Show notes: https://healthpodcastnetwork.com/show/confessions-of-health-geeks/https://www.linkedin.com/in/clairebonaci/https://entrepreneur.m12.vc/submithttps://steveblank.com/2013/08/20/reinventing-life-science-startups-medical-devices-and-digital-health/ Music by keldez

Jan 6

23 min 50 sec

Our guest today is Meow-Ludo. He’s an emerging technology evangelist and Chief Scientific Officer at Moth Diagnostics, a company formed in response to the covid pandemic. Meow has a background in solving problems using biotechnology and helped found the biohacker movement in Australia. This culminated in the establishment of BioFoundry, Australia's first open access molecular biology lab, with Moth Dx co-founder Adrian Pearce.Meow has also run for federal parliament with the science party and flux party, advocating for data driven policy and technological improvements to democracy. He is perhaps most well known for one of the world's first cyborg law cases, fighting for the right to use an implanted travel card in his hand that gained worldwide attention.Lots of takeaways from today’s show. One in particular about having a global mindset. Hope you enjoy. 

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Dec 2020

21 min 38 sec

2020 has been an unprecedented year. In times like these, mission-driven companies should challenge themselves to stay focused on their immediate goals while not losing sight of their bigger vision. In an effort to reinforce our mission and demonstrate our values, Qualio is committing to what we call 1% For All Life. Starting this year, Qualio will donate 1% of our annual revenue to improving healthcare access for vulnerable populations.Qualio's mission is to enable organizations to launch and scale life-saving products. While this supports our core belief that everyone deserves to live a long, happy, and healthy life, we are now expanding our mission by supporting organizations that ensure underserved communities receive the healthcare they need. Increasing the quantity and quality of treatment options does little to help those who cannot easily access the existing healthcare system. I saw this first hand while working as a pharmacist in large urban centers, rural communities, and drug addiction services in Ireland's largest prison. It became clear to me that the ability to access quality healthcare has an enormous impact on people's lives, and that we all have an opportunity to make a difference here.After months of living through a global pandemic, we feel privileged to be able to give something to those that need better healthcare access. Here is where our donations will go in 2020:40% to the Bill & Melinda Gates Foundation, Combating COVID-19 Fund40% to the Saint Francis Foundation20% to Qualio Team Member choice (each Qualio team member is given an amount to donate to a cause of their choosing)To all our wonderful teammates, customers, and partners - thank you from the bottom of our heart for making all of this possible.Show notes:https://www.saintfrancisfoundation.org/See more information about From Lab to Launch by QualioMusic by keldez

Dec 2020

43 min 29 sec

If you have a nose, you should check out this episode. Dr. Hana Solomon, MD shares her journey from hippie to single-mother to med school to entrepreneur. She's the founder of BeWell Health and inventor of Nasopure, the most comfortable nose wash in the world. She shares her wisdom to avoid "stupid business mistakes" such as acquiring the right type of patent for your product (e.g., design vs. utility patent)  and being financially braver to go bigger sooner. Dr. Hana talks about little things, each of us can do to improve our health. Also at the end, she kindly offers a coupon code to get a discount on her nose wash product. Guest bio:Dr. Hana Solomon, MD graduated from the University of Missouri Columbia School of Medicine in 1986 and completed the university's pediatric residency program in 1989. For 20 years Dr. Hana has practiced pediatrics at the Solomon Family Medical Clinic in Columbia, Missouri.Her articles have been published in the Wall Street Journal, Medscape's webmd.com, About.com, Natural Apathy Digest and other health-related publications. Dr. Hana started BeWell Health in January, 2001. The company's flagship product, Dr. Hana's Nasopure nasal wash systems have helped millions to maintain nasal and sinus health naturally.Links:Nasopure Amazon Storewww.nasopure.comhttps://www.facebook.com/nasopure.nicer.netiUse "QNasopure" coupon code on AmazonSee more information about From Lab to Launch by QualioMusic by keldez

Dec 2020

19 min 34 sec

What if the next time you went to the receive healthcare at a clinic or hospital, you came out with an idea to improve the patient's experience? That's what Cinde Dolphin did. She's a 4x cancer survivor and CEO/founder of KILI Medical Drain Carrier. Between surgeries, she went to a dollar store to begin prototyping a device that would improve her experience as a patient. Her nurse team loved it. Her doctors loved it. What followed was her journey into entrepreneurship in life sciences. Cinde shares her with story, which is an inspiring one, from patient to founder. Guest Bio: Cinde Dolphin is the CEO and founder of KILI Medical Drain Carrier. She's also a member of the Academy of Oncology Nurse and Patient Navigators. She likes to challenge the status quo. She's a four time cancer survivor and she's been through nine surgeries. Her malady was a catalyst to create a simple, yet elegant solution to manage post-op drains and improve upon the 50 year old conventional protocol, which involved attaching drains using safety pins. Cinde enjoys speaking to the medical community, as well as to the general public about the importance of patient innovations or from their experience, the insights they gain, create solutions, which help others with the same medical issues that they suffered. These former patients are determined that others will not have to contend with the problems that they had, and she believes truly in paying it forward. Links: https://medicaldraincarrier.comhttps://www.linkedin.com/in/cdolphin/Educational Fact SheetSee more information about From Lab to Launch by QualioMusic by keldez

Dec 2020

21 min 23 sec

Ron Shigeta is a serial entrepreneur & startup biotech pioneer. He’s also been a serial founder having run startups in AI drug tox detection & synthetic biology. Ron holds a PhD in Chemistry from Princeton University, where he spent his academic research career focusing on secondary metabolic biosynthesis, diabetes, genomics, genetics, structural biology and systems biology.  As an entrepreneur, investor, scientist, and mentor Ron shares some great insights to anyone who wants to contribute to life sciences. Some takeaways:Starting a biotech company today is much easier and cheaper than at any other timeAdvice to founders to gain relevancy and trust from investors and get fundingBiotech investments now are where software was 2+ decades agoLinks:https://www.linkedin.com/in/startupminute/https://www.alix.vc/ron-shigetaThe Bio Revolution by McKinsey Global Institute See more information about From Lab to Launch by QualioMusic by keldez

Dec 2020

22 min 48 sec

Welcome to the From Lab to Launch podcast by Qualio. Discover inspiring stories from those on the front lines of life sciences. You’ll hear founders share their insights from launching and scaling their business, investors giving their outlook on funding, industry experts unfolding their latest insights and research, and quality professionals offering advice to navigate the regulatory maze and avoid audit pitfalls.Episodes are about 30 minutes and published each week on all major podcast players. Tune in and leave inspired to bring your life saving products to the world.If you want to be a guest on the show, fill out this brief application: https://forms.gle/Yp7uKnSXTCPtTdRcA.Music credit:Keldez

Nov 2020

45 sec