To celebrate our 4th Annual Women in OC Medtech Event, we will be doing an interview with event panelist Marinela Gombosev. Marinela is CEO of Evoke Neuroscience, a data and diagnostics company focused on reducing the number of people living with treatable cognitive impairment. After immigrating into the United States as a war refugee from Bosnia at the age of 14, she went on to complete her undergraduate studies in Electrical Engineering at the University of California, Irvine and received an MBA from Pepperdine University where she was recognized as a “Top 40 under 40” alumna. In 2015, Marinela was inducted into the University of California, Irvine School of Engineering Hall of Fame as the youngest recipient of this award. She has spent her entire 15 year career in regulated industries, the most recent 10 of which have been in medical devices.
In this episode of DeviceAlliance’s Medtech Radio, we discuss her experience coming to the US, the importance of why soft skills in leadership are essential in these times, the impact of Alzhimers’s Disease and Evoke Neuroscience’s solution for cognitive impairment, what women can do to prepare themselves for success during these times, and much more!
Creighton ChaneyMarinela Gombosev: Developing Soft Skills in Leadership | Ep.29
Orange County-based medical diagnostic company Fluxergy has taken the next step toward getting a high-speed test for COVID-19 available for use. Fluxergy submitted an emergency use authorization request to the U.S. Food and Drug Administration Center For Devices and Radiological Health, seeking an authorization that would permit medical professionals to begin using the company’s test system as a COVID-19 diagnostic at the point-of-care. Advanced rapid point-of-care tests for COVID-19 may have the potential to save significant time compared to standard lab tests that must be shipped to centralized laboratories for processing. Fluxergy’s on-site sample- to-answer test for COVID-19 requires a very small sample, typically a nasal swab, which is mixed with a reagent solution, loaded onto a card and inserted into the analyzer in a two-step procedure.
In this episode of DeviceAlliance’s Medtech Radio we with speak CCO of Fluxergy, Dr. Ali Tinazli. He also serves as Business Partner & Strategy Advisor
with Immunaccel, and is a Member of the Strategic Advisory Board of InnVentis Ltd. Join us as we discuss Fluxergy’s goal to make laboratory testing accessible everywhere, the challenges facing current labs, and how our current environment is acting as a catalyst for the next generation of medical device innovation.
Creighton ChaneyDr. Ali Tinazli: Quick Turn Diagnostics | Ep.24
Before one begins any new project, it’s important to understand where you fit into the grand scheme of things. While you may be the person who had the brilliant idea in the first place, that doesn’t mean you know how to lead a company, or build a team, or build a prototype. You can’t be all things to all people. One needs to know what you’re good at, and then you need to know how to hire the best people to fill the positions that you can’t cover. The very first question you should ask is, am I the person who should lead my new company, or do I need to hire a leader who can take my idea and run with it?
In this episode of DeviceAlliance’s Medtech Radio, we speak with the Chief Technology Officer at Balt, Dave Ferrera. He also serves as a member of the Board of Advisors to Spinal Singularity, a member of Sage Executive Group, and Chair Orange County American Heart Association Heart & Stroke Ball 2020. Join us as we discuss his upcoming book Innovation in Translation, the critical lessons learned through his early startups, and what it takes to build a team of “A players”.
Creighton ChaneyDave Ferrera: Innovation in Translation | Ep.23
After giving birth to her second child in 2011, JillBigelow was frustrated that her hospital’s solution for her pelvic discomfort was ice in a rubber glove, gauze underwear and pain medication. After scouring both the medical and maternity markets, Bigelow was surprised to discover there was no singular product that truly addressed all her physical ailments as a new mom. With her entrepreneurial spirit, she set out to design a product for modern mamas that helped them heal their bodies from the physical damage of pregnancy and childbirth. In 2013, her prototype was classified by the FDA and in 2014, she celebrated the launch of her company PELV-ICE™ and its first medical device of many, the Mama Strut™.
In this episode of DeviceAlliance’s Medtech Radio, we speak with the Founder of PELV-ICE LLC, JillBigelow. Join us as we discuss her journey as a medtech founder and how she identified a huge gap in women’s health care, the importance of marketing/brand awareness, and lessons learned through her entrepreneurial challenges.
Torey ConradJill Bigelow: Reshaping the Healing Experience | Ep.21
In recent years, research on light therapy has moved from the fringes of scientific discovery to something closer to the mainstream. Its commercial uses are now following the same path, as these devices, once available only in spas, gyms, or dermatologists’ offices, become increasingly affordable for consumers. Meanwhile, the research is only getting more ecstatic. BioPhotas Inc. is providing unique devices founded on NASA-developed technology and backed by clinical studies, that conveniently treat a variety of skin, muscle and joint conditions. By the end of 2019, Celluma received the Innovative Product of the Year Award from The Aesthetics Journal in the United Kingdom. Celluma has already received another three Product of the Year awards from U.S.-based skin care journals, including Dermascope Magazine’s award for Best Full Body LED device, for the company’s innovative Celluma DELUX.
In this episode of DeviceAlliance’s Medtech Radio, we speak with the President & Chief Executive Officer at Celluma by BioPhotas, Patrick Johnson. Join us as we discuss his journey as a medtech founder while sharing his insights on how his philanthropic passions drove his purpose, lessons in leadership, and his role of ringing to market safe, effective and affordable devices that unlock the clinical power of low-level light therapy.
Creighton ChaneyPatrick Johnson: Turning Passion Into Purpose | Ep.20
LensGen is a clinical stage company headquartered in Irvine, California focused on restoring youthful vision to millions of cataract and presbyopia patients. With its innovative Juvene™ modular fluid optic intraocular lens the company aims to treat vision correction errors and provide spectacle independence to patients affected by cataracts and/or presbyopia. Their leader is a serial entrepreneur with 25 years of experience in the ophthalmic pharmaceutical and device industry. What are some of the key strategic insights to scaling a startup to a large scale medtech organization?
In this episode of DeviceAlliance’s Medtech Radio, we speak with the CEO of Lensgen, Inc., Ramgopal Rao. Ram is the Inventor, Founder, and Chief Executive Officer of LensGen, Inc., a clinical-stage medical device company that is developing a novel intraocular lens for presbyopia. Currently, he is also Chairman of the Board of 2C Tech Corporation, Inc., an emerging medical device company that is developing a novel nanotechnology application for preservation of vision for patients with degenerative retinal diseases. Join us as we discuss his journey as a medtech founder as he shares his insights on understanding the long game, the role of clinical innovators & investors, the difference between money and smart money, and embracing your entrepreneurial passion.
Creighton ChaneyRam Rao: Vision with Purpose | Ep.19
Medtech entrepreneurship is on the rise, and for good reason. The continual growth that’s seen within the life sciences industry in Orange County has been attracting an increasing number of international investors and VC firms. Venture capital firms have set their sights on the Southern California life sciences industry, which is displayed by the fact that the amount of VC investment for 2018 was around $7.6 billion for biotech and medical devices. It’s a good time to be involved in the startup scene. Yet entering the world of MedTech startups is complex and rife with unique challenges. When 90% of startups fail, what does one need to know about the 10% that don’t? What are the best practices to cover blind spots one may have when launching a MedTech startup?
In this episode of DeviceAlliance’s Medtech Radio, we speak with the Director of LaunchPad & Investor Relations at OCTANe OC, J.C. Ruffalo. Join us as we discuss how to properly launch your startup Medtech company, creating a cohesive business plan, and amplify your capital funding strategy. Learn insight from over 600 successful LaunchPad Alumni since 2010, and discover why LaunchPad ranks in the top 5 out of over 900 SBDCs in the United States.
Creighton ChaneyJ.C. Ruffalo: How to Successfully Launch a Medtech Startup | Ep.17
Last September of 2019, Foldax, Inc. announced its first-in-human use of the Tria heart valve under its FDA Early Feasibility Study (EFS) for the treatment of aortic valve disease. Tria heart valves combine LifePolymer™, an advanced biopolymer material, and a patented design to create a valve with the potential to lower the cost of medical care given the increasing costs of using animal tissue valves and the associated durability and calcification concerns. The proprietary biopolymer material and design of the Tria heart valves also allow for high volume manufacturing. The valves are robotically manufactured to provide the highest level of quality and precision and allow for future patient customization while eliminating the variability of human production.
In this episode of DeviceAlliance’s Medtech Radio, we speak with the Executive Chairman of Foldax Inc., and Exec Chairman Chief Strategy Officer of Compellon Inc. Ken Charhut. Join us as we discuss how this groundbreaking technology was created, what major milestone this represents for heart valve patients worldwide, and how the progress toward mitral and transcatheter versions of the valves next year has the potential to revolutionize the heart valve industry.
Creighton ChaneyKen Charhut: The Future of Heart Technology | Ep.16
Did you know that 50% of concussions go unreported or undetected? If you or a loved one had a concussion, what signs would you look for? What should you do if you think you or your child has had a concussion? How can clinicians collect objective data to make better-informed decisions about the nature of the impairment, and the corresponding treatment needed to optimize recovery?
In this episode of DeviceAlliance’s Medtech Radio, we speak with the Chief Clinical Officer of SyncThink, Inc. and Medical Observer for the NFL, Scott Anderson. Join us as he shares his clinical expertise on what exactly a concussion is, signs of recognizing a concussion in yourself and others, and how SyncThink is assisting medical professionals in assessing brain health, monitoring health, and optimizing performance. Scott also shares his experience with working at NFL games for the past seven years, and how the culture of concussion diagnosis and care has changed.
Contrary to popular belief, success isn’t defined by how well you did in school or how many degrees you have. It isn’t based on what family you had or where you grew up. It comes down to your personality, your mindset, and your outlook on life. You don’t even have to be a type-A person to be a successful entrepreneur. Entrepreneurs tend to be more “street smart” than “book smart.” Entrepreneurship can mean many things, but ultimately, it’s about paving your own path. So, do you have what it takes to be a medical device entrepreneur?
In this episode of DeviceAlliance’s Medtech Radio, we get into the mind of serial medical device entrepreneur Ben Bobo. Join us as he reflects on his business life lessons, while tackling many questions including…
How should entrepreneurs look at calculated risk?
Creighton ChaneyBen Bobo: The Flight Of An Entrepreneur | Ep.1
