From Lab to Launch by Qualio

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 compan...

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 adva...

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 revolution...

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 sy...

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 he...

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...

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" (Gx...

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 eve...

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. Aft...

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 ove...

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 con...

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 ca...

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 j...

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, man...

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 communicat...

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 expert...

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...

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...

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 wr...

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 injur...

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...

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 inclu...

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 medi...

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 depa...

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, wi...