Episode Details

Andrew Lyon: Leadership Beyond the Classroom

Ep. 28

Dr. Lyon’s research interests center around the design, synthesis and application of soft (synthetic and natural polymer-based) nanomaterials in bioanalytical and regenerative medicine applications. Specific projects under investigation include the development of artificial platelet technologies, colloid-modified biopolymer scaffolds, self-healing polymer films, new bioanalytical sensors, and reconfigurable materials to direct cell proliferation and differentiation.


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Juliana Elstad: The Grand Strategy | Ep.54

Juliana Elstad is the President, CEO of Vibrato Medical.  She is a global executive with significant experience identifying opportunities for growth and delivering success in start-ups to multi-billion-dollar companies, and has led innovative medical companies through compelling vision, strategy, and growth.  She has worked both in start-ups and Fortune 500 corporations in the U.S. and

Bill Colone: The One Thing | Ep.53

MedTech startups found themselves flush with cash a couple of years ago for quite obvious reasons. Pandemic-fuelled investment pushed VC funding for medtech and health-focused companies to unforeseen heights. But times have certainly changed. The medical device industry now finds itself reckoning from the banking crisis and VCs shifting priorities (and funds) towards other opportunities.

Roger Holmes: Reaching Across the Pond | Ep.52

In an ideal world, no one would have a catheter, but the reality is that 100M patients worldwide rely on an indwelling urinary catheter.  Catheterized patients often experience problems, such as catheter-associated urinary tract infections (CAUTI), catheter blockages, leaking and bladder spasms.  FLUME estimates the healthcare burden of Foley catheter complications to be equivalent to $80

Monica Pleasant: The Great Realignment | Ep.51

It’s been almost a year since Anthony Klotz, a psychologist and professor of business administration at Texas A&M University, coined a famous phrase when he said “the great resignation is coming” in an interview with Bloomberg Businessweek.  The popular phrase refers to the elevated level in early 2022 coming off a year in which almost

William Curtis: Driving Diagnostic Excellence | Ep.50

In Episode 50, we speak with CEO of nRichDX, William Curtis. nRichDX’s patented IVD-labeled platform is the result of an intensive technology development effort that commenced in 2016 and was commercially launched in November 2019.  It’s a patented sample prep system that in its current state already provides up to 10x more genetic targets for

Osman Khawar: Consumer Centric Dialysis | Ep.49

Today we speak with CEO of Diality, Osman Khawar.  Diality is a privately held medical device company currently in development of a versatile hemodialysis machine useable at home or in a variety of care settings, including nursing homes, hospitals, transitional care facilities and dialysis centers*. Committed to helping build a future where all patients and

Ramin Mousavi: Innovation Leadership Mindset | Ep.48

Ramin Mousavi is the CEO, President, and Board of Directors for Cathworks; a medical technology company focused on applying its advanced computational science platform to optimize Coronary Artery Disease (CAD) therapy decisions and elevate coronary angiography from visual assessment to an objective FFR-based decision-making tool for physicians.   Ramin has executive leadership and operational experience in general

Kristy J. Kennedy: The Changing Tide of Medtech Marketing | Ep.47

Your Medtech brand is not something an agency gives to you. Nor is it something you buy. Your brand is defined by the relationship you have with your customers, and it’s shaped by the messages you send and the response those messages elicit.  Getting the attention of busy physicians and hospital executives is more challenging than

Axis Research & Technologies: Medtech Training Camp | Ep.46

AXIS Research & Technologies, Inc. was an idea that originally started from a non-profit created by Founder and CEO Nick Moran to educate youth about the negative effects of diabetes and being overweight. That nonprofit morphed into a broader opportunity to create a Bio Skills Company to provide facilities, medical equipment and tele-training services for surgeons, medical professionals

Dave Saunders: The Present and Future of Medtech AI | Ep.45

Robots in the medical field are transforming how surgeries are performed, streamlining supply delivery and disinfection, and freeing up time for providers to engage with patients. Health robotics will continue to evolve alongside advancements in machine learning, data analytics, computer vision, and other technologies.  These contributions support ongoing innovations that increase automation, drive efficiencies, and solve

Bryan Starr: Community Investment in Global Medtech | Ep.44

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 facilities and community

Live DA Event: Critical Thinking on Clinical Trial Success | Ep.43

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

Hayley Haggarty: Building A Better World | Ep.42

MD&M West is the nation’s leading advanced Medtech design & manufacturing conference.  It brings together Medtech engineers, business leaders, disruptive companies, and innovative thinkers to create powerful solutions and life-changing medical devices.  From 3D printing and biomaterials to robotics and digital health, MD&M West is the largest Medtech expo for suppliers and buyers to discover innovation,

Thomas Hopson: Leadership Built to Last | Ep.41

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. Thomas Hopson

Sarah Boundy Wong & Vinny Podichetty: The CRO Selection Blueprint | Ep.40

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, keeping your clinical research trial

Scott Pantel: The Endless Data Challenge | Ep.39

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, Medtech companies are also looking outside their normal sector boundaries to explore creative solutions to

Claudia Graham: Market Access & The Reimbursement Roadmap | Ep.38

It has been said that it takes an average of 4.6 years and tens to hundreds of millions of dollars to get a medical technology through R&D, Regulatory, Manufacturing, and Clinical Research before it is successfully commercialized and sees wider acceptance and adoption. That is a very long lead time and hundreds of thousands of

Dr. Michael Dreus: The Consumerization of MedTech | Ep.37

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.  The connected

Stan Rowe: The Three Legged Stool | Ep.36

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.

Manisha Dhawan: Plotting Your Medtech Career Course | Ep.35

By the end of the current academic year, American schools will have conferred an estimated 3.7 million high-school diplomas, 1 million associate’s degrees, and 2 million bachelor’s degrees. Many of those 6-million-plus graduates will soon pursue another degree, but many others will enter a historically tough labor market. However, the Bureau of Labor Statistics of

Svetla Kibota: The Head and Heart of Medtech Branding | Ep.34

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 launches have

PRO-TECH: Designing Workflow | Ep.33

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

Denae Bluethmann: Winning Resumes & Interview Techniques | Ep.32

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 age-old process.

Dr. Keith McCrea: Fighting the Cytokine Storm | Ep.31

In June, the Department of Defense announced it was funding a clinical trial of the device because it showed encouraging preliminary results in critically ill COVID-19 patients at a military hospital in the U.S. and 14 other hospitals in Europe. ExThera Medical’s Seraph 100 extracorporeal blood filter could go a long way in helping COVID-19

Taylor McPartland: Entrepreneurial Recipes for Success | Ep. 30

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.

Marinela Gombosev: Developing Soft Skills in Leadership | Ep.29

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

Andrew Lyon: Leadership Beyond the Classroom | Ep.28

Dr. Lyon’s research interests center around the design, synthesis and application of soft (synthetic and natural polymer-based) nanomaterials in bioanalytical and regenerative medicine applications. Specific projects under investigation include the development of artificial platelet technologies, colloid-modified biopolymer scaffolds, self-healing polymer films, new bioanalytical sensors, and reconfigurable materials to direct cell proliferation and differentiation.

Warren Foust: Leadership Through Authenticity | Ep.27

Warren Foust is the Worldwide President for Johnson & Johnson Vision surgical business. Most recently, Warren served as Worldwide President of Mentor where he also previously served as Vice President, U.S. Sales & Marketing. Under his leadership, Mentor has gained share, shown double-digit growth, and reestablished clear market leadership. Warren joined Johnson & Johnson through

Kevin McNerney: Where Everyone Knows Your Name | Ep.26

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 reveal 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

Nested Knowledge: The Currency of Science | Ep.25

Nested Knowledge was founded by Keith and Kevin Kallmes, two brothers who have spent the past 3 years building a neurovascular-focused research company. While working with organizations as diverse as strategic device companies, research hospitals, private practice clinicians, and medical device startups, Kevin became frustrated with how difficult it was to compare therapies in the

Dr. Ali Tinazli: Quick Turn Diagnostics | Ep.24

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

Dave Ferrera: Innovation in Translation | Ep.23

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

Richard Oberreiter: New Frontiers in Vascular Health | Ep. 22

In October of 2019, Modulim, a recognized leader in optical imaging solutions for noninvasive tissue assessment, announced the appointment of Richard Oberreiter as its new CEO.  Modulim is a pioneer in subsurface optical imaging powered by SFDI, an advanced imaging technique co-invented by founder and CTO David Cuccia, Ph.D.  SFDI is a noninvasive tissue oxygen saturation technology that

Jill Bigelow: Reshaping the Healing Experience | Ep.21

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

Patrick Johnson: Turning Passion Into Purpose | Ep.20

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.

Ram Rao: Vision with Purpose | Ep.19

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

Raymond Cohen: Persevering in OC Medtech | Ep.18

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 bladder and bowel dysfunction. Axonics has received industry recognition for

J.C. Ruffalo: How to Successfully Launch a Medtech Startup | Ep.17

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

Ken Charhut: The Future of Heart Technology | Ep.16

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

Kwame Ulmer: Advancing Diversity in Medtech | Ep.15

There is immense untapped potential for underrepresented groups within the MedTech industry. How does one take on the immense challenge of increasing the number of persons of color who can make a meaningful contribution to the life-saving MedTech industry? Why is it important for businesses to diversify workforces? How does mentorship impact groups that are

Stacey Pugh: Change Agility in Neurovascular | Ep.14

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

Annette Walker: Fighting Cancer in Orange County | Ep.13

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

Jon Speer: Bringing Safe Products to Market Fast | Ep.12

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

Scott Anderson: Battling Concussions | Ep.11

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

Linda DiMario: Bringing Global Medtech to Irvine | Ep.10

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

Travis Smith: DeviceAlliance, Future Forward | Ep.9

Over the next ten years, Orange County is trending to be one of the fastest growing medical device centers in the world. The key question then becomes, what resources are needed to continue elevating today’s medical device leaders while developing the newly emerging next generation of talent? Join us as we talk about the origins

Mike Mussallem: In the Heart of OC Medtech | Ep.8

The blossoming life sciences and medical device community in Orange County has shown incredible growth over the past few years. According to the 2019 California Life Science Association report, Orange County directly employed nearly 45,000 people in the life sciences industry, up 11% over the previous year. Of those, more than 23,000 were employed by

Joanne Ly: Mental Health – From Passion to Purpose | Ep. 7

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 the conversation. One inspiring woman

Jeff Blanton: Discover Your Calling | Ep.6

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

Omnica Corporation: Orbiting Medical Product Development | Ep.5

Medical device design and development is a complex process rife with regulations, specifications, application requirements, and end user needs — all of which must be balanced and adhered to for a successful product. If your device lacks usability, market share will suffer, but if your device doesn’t meet regulatory guidelines, it won’t make it to

David Powell: Leadership Lessons | Ep.4

What is leadership? It’s such a simple question, and yet it continues to vex popular consultants and people alike. True leadership is much more than authority and recognition from the outside world. Instead, leadership is all about developing people and helping others reach their full potential. The bedrock foundation that your leadership will be built

Ryan Blackmore: People Strategies | Ep. 3

Today’s changing work environment means many qualified employees have a much easier time heading for greener pastures to find the right financial compensation and cultural fit. While corporate culture is influenced by organization members, HR plays a pivotal role in setting a company’s cultural tone. As a business function, HR shapes and reinforces how employees

Bridget Smith: Blockchain Revolution | Ep.2

Is Blockchain the Next Great Disruptor in the Medical Device Industry? Blockchain has the potential to transform how medical devices are created, controlled, managed, and acted upon throughout the life of the device. As businesses continue to grapple with core IoT complexity and security problems, it is becoming obvious that blockchain-based solutions have merit and

Ben Bobo: The Flight Of An Entrepreneur | Ep.1

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