From Lab to Launch by Qualio

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.com
• https://www.techemerge.org/
• Assaf on LinkedIn

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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

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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. 

1. ABLE HUMAN MOTION
2. DAY ZERO DIAGNOSTICS
3. GARWOOD MEDICAL DEVICES
4. X-COR THERAPEUTICS
5. FLATIRON HEALTH

If 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/viewform

See interviews and episodes on https://www.qualio.com/from-lab-to-launch-podcast.

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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

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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 Galvin

Jeff 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 LinkedIn
• Jeff on Twitter: @jeffreygalvin
• https://www.americangene.com/
• Press Release about AGT's FDA approval to continue HIV cure program
• AGT on LinkedIn
• AGT on Twitter - @americangene
• AGT on Facebook - @amerigene
• AGT on Instagram - @americangenetechnologies

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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

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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 LinkedIn
• NIH.gov

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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

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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 LinkedIn
• www.cognixion.com
• Cognixion Press Kit

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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

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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

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

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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/ 

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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

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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/

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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

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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.com
• Jen's LinkedIn: linkedin.com/in/jenbaird
• Jen's blog:  www.StartupCEOReflections.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

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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.com
• Charleen on LinkedIn

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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