DeviceAlliance: MedTech Radio

ScaleHealth is an innovation ecosystem focused on connecting great innovators in the health/wellness space, with the strategic resources and partnerships with the goal to impact communities in need.  On April 7th ScaleLA formally announced that it will be renamed ScaleHealth, a move which coincides with the announcement to open a 2nd location in Orange County.  This location will be launched in pa...

To celebrate our 4th Annual Woman in OC Medtech Event, we will be doing a 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 unde...

In November of 2019, DeviceAlliance celebrated its 10th year anniversary.  This was a huge milestone for the organization given that data from the National Center on Charitable Statistics reveals that approximately 30% of nonprofits fail to exist after 10 years.  According to Forbes, over half of all nonprofits that are chartered are destined to fail or stall within a few years due to leadership i...

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...

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 be...

After giving birth to her second child in 2011, Jill Bigelow 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 entrepreneuria...

n 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 u...

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...

Podcast Recap – looking back on our 1st year with Device Alliance Medtech Radio, we're thrilled to have built such a healthy following with 7,000+ listens to date. One of our favorite episodes was with Mike Mussallem, CEO of Edwards Lifesciences . Mike's perspective on what's needed in OC to keep the medtech engine going was both insightful and refreshing. If you missed this episode when it first...

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 wa...

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 lowering the cost of medical care given the increasing costs of using animal tissue val...

Strokes are the number one cause of disability in the world, and the second cause of death globally.  In addressing this challenge, Medtronic grew to become the largest medical device company in the world.  With key strategic acquisitions, Medtronic experienced unparalleled growth.  In such a business environment, how does a professional adapt the change agility to scale themselves at the same rat...

The City of Hope will invest $1 billion in a new hospital and research center in Irvine that will enhance the way cancer care is delivered in the region.  The large-scale facility will include a hospital and a research facility conducting clinical trials of new drugs and medical devices.  The cancer incidence rate in Orange County is projected to increase by 18% over the next decade, as cancer ris...

How does one take a medical device idea on a napkin to a 510k approval to market release as efficiently as possible?  How does one manage risk to drive the safety and quality of products and processes, while striving to be first in a innovative market?  How does one change their company's focus from simply meeting regulations to building quality into their processes as a differentiator? How does o...

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 impairment, and the corresponding treatment needed to optimize recovery?  In this episode of...

The medical device sector is one of the largest and fastest growing industries in Irvine.  As such, The Greater Irvine Chamber of Commerce is creating task forces to attract and engage talent from the community to meet tomorrow's challenges head on.  How can you be a part of strengthening Irvine's international profile and medtech ecosystem?    In this episode of DeviceAlliance's Medtech Radio, we...

In this episode of DeviceAlliance's Medtech Radio, we interview Chairman and CEO of Edwards Lifesciences, Michael Mussallem.  Join us as we speak with Mike about how Edwards plans to support Orange County's medical device community, and what we can do to drive collaboration, innovation, and career development for all device professionals in Southern California.