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Join us on DeviceAlliance's Podcast: MedTech Radio where we interview today's brightest minds in Southern California's medical device industry. Each episode deconstructs complex topics and provides the tactics, tools, and strategies to overcome tomorrow's challenges. DeviceAlliance strives to be the one-stop-shop at the center of the medical device ecosystem helping drive collaboration, innovation, and career development for all device professionals in Southern California.
 
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show series
 
Irvine is home to over 15,000 businesses, and life sciences and medical device companies constitute one of the fastest-growing sectors. With a global focus on the Medtech industry, the need to build an infrastructure that can support the explosive forecasted growth is more crucial than ever. A well-educated, job-ready workforce, world-renowned R&D …
 
You’ve got a great idea for a medical device! Now what? Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is absolutely crucial for clinical trial success. With the explosion of Medtech opportunities for startups, what are the current best s…
 
What is leadership, anyway? Such a simple question, and yet it continues to vex popular consultants and laypeople alike. Leadership is a process of social influence, which maximizes the efforts of others, towards the achievement of a goal. In this episode of DeviceAlliance’s Medtech Radio, we speak with the President of Bioplatte, Thomas Hopson. Th…
 
What are Contract Research Organizations? For any Medtech company, working with CRO’s allow them to outsource work that would otherwise require significant capital to do internally. CRO's let you avoid buying expensive equipment and hiring or training staff for a short-term project. Having independent oversight is critical to ensuring compliance, k…
 
COVID-19 has put the MedTech industry at center stage with unparalleled demand for diagnostic tests, personal protective equipment (PPE), ventilators, and other critical medical supplies. In addition to the extraordinary measures underway to rapidly ramp up manufacturing capacity and capabilities, MedTtech companies are also looking outside their n…
 
For medical device companies, the consumerization of Medtech represents a new paradigm. In the past, medical devices were more targeted toward healthcare providers and payers – now there is a demand for direct-to-consumer products. People are demanding to have more control over their healthcare and they want the ability to proactively manage it. Th…
 
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 a…
 
Medical device marketing teams are facing unprecedented times as we close out in 2020. As companies emerge from COVID-19 constraints, marketing teams are struggling to refocus their respective work roles and manage the transition back to the workplace. The challenges that marketing teams are facing are more daunting this year than ever. Product lau…
 
Deerfield Management and Stan Rowe created a therapeutic device incubator, NXT Biomedical. NXT Biomedical expects to invest up to $25 million in cutting edge technologies over the next 5 years. Deerfield has allotted up to an additional $250 million for the formation and development of five to eight startup companies that emerge from the incubator.…
 
In January of 2020, Axonics Modulation Technologies, Inc. announced FDA approval of an enhanced, second-generation Programmer for its r-SNM® System under a premarket approval application supplement. This medtech company has developed and is commercializing novel implantable rechargeable Sacral Neuromodulation (SNM) devices for the treatment of blad…
 
Accurate medical device labeling is a critical component to any quality control system. Often though, labeling is only considered at the end of the packaging process, which in itself, is often at the end of medical device design and production. Typically, product engineers develop a device, and only then start to think about how they are going to p…
 
With the flurry of activity that has been happening in the Medtech industry, having a proper strategy for conducting interviews virtually and in-person is more important than ever. All professionals have engaged in the interview process. However, there is an astonishing lack of effort given to systematic attempts at building improvements into this …
 
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 Ora…
 
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…
 
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…
 
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 professiona…
 
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 a…
 
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 physica…
 
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 gettin…
 
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 …
 
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 refr…
 
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 f…
 
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 give…
 
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 cha…
 
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 inc…
 
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…
 
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 n…
 
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 …
 
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…
 
Eradicating the enduring social stigma related to mental health conditions is uniquely challenging. The nature of mental health services can make it difficult to develop medical device technology that successfully intervenes in human behavior and actually creates measurable, positive outcomes. Many times the most difficult task is to simply have th…
 
When people talk about having a purpose in your professional or personal life, they often sound like a self-help book. However, having a purpose in your work and life can help you become more motivated and push you to go above and beyond. When we talk about ‘finding your purpose’, we’re referring to an overarching goal that drives you. This can be …
 
In this episode of DeviceAlliance’s Medtech Radio, we interview Jörg Lorscheider, Director Of Sales & Marketing at Omnica along with Earl Robinson, President at Omnica. Join us for a in depth discussion on the unique challenges of medical device product development, the difference between products that "go big" and those that struggle, and the peri…
 
Welcome to the 2nd episode of the DeviceAlliance podcast, the show driving collaboration, innovation, and career development for medical device professionals in Southern California. In this episode, Scott Johnson speaks with Bridget Smith about the exciting impacts of blockchain technology on the healthcare and medical device industry. Please subsc…
 
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