DeviceAlliance: MedTech Radio

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 Emerging Markets and has worn many leadership “hats” in the medical device business.   She serves as a ...

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. That shift has caused funding for early-stage medtech companies to decline significantly, with numbers sl...

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 on average, for each of the 28m placed annually in the US - a total burden of around $2.2bn - and close ...

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 48 million people quit their jobs, an annual record.  As one can imagine, this revolution of sorts has caused quite a stir amongst the HR Community, with expe...

William Curtis: Driving Diagnostic Excellence | Ep.50

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 partners can control kidney disease, Diality is focused on developing solutions that help care providers improve the care and lives of p...

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 management, marketing, strategy, product development, and commercialization a...

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 ever for medical device manufacturers across the globe. Doctors are busier and have less time to see patients, let alone talk to a sales representative. Successf...

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

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

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 initiatives all conspire to make Irvine a magnet for Medtech success.  So how is Irvine executing on their 50-year pla...

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 best standards for ensuring the success of your design and clinical trials? Join us for this Live-Recorded Podcast Event "Proving Your Device Wor...

Hayley Haggarty: Building A Better World | Ep.42

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 is an accomplished business executive with over 30 years of experience in the medical device industry. Thomas has provided ...

Sarah Boundy Wong & Vinny Podichetty: The CRO Selection Blueprint | Ep.43

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 on track and bringing your device to market faster.   For this reason, many companies hire a clinical res...

Scott Pantel: The Endless Data Challenge | Ep.42

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 normal sector boundaries to explore creative solutions to strategize how they will supplement capacity, open-source equipment design, and address ...

Claudia Graham: Market Access & The Reimbursement Roadmap | Ep.41

Dr. Michael Dreus: The Consumerization of MedTech | Ep.40

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 health and wellness devices market is expected to reach $612 billion by 2024, according to a report by Grand View Research Inc. and ...

Manisha Dhawan: Plotting Your Medtech Career Course | Ep.39

Dave Ferrera: Innovation in Translation (Replay) | Ep.39

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,...

Svetla Kibota: The Head and Heart of Medtech Branding | Ep.38

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 been delayed, sales have been lost, and trade shows have been canceled.  We’re coming into business planning time and marketing...

Stan Rowe: The Three Legged Stool | Ep.37

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.  NXT Biomedical provides an exciting new pathway for exceptional science to be incubated with the world-renowned leadership while continuing to...

Raymond Cohen: Persevering in OC Medtech (Replay) | Ep.36

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 its technology, including one of FierceMedTech’s Fierce 15 Companies in...

PRO-TECH: Designing Workflow | Ep.35

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 package and sterilize it. And, then after all that work is done, and typically only after that, do OEMs (original equipment manufacturers) and thei...

Denae Bluethmann: Winning Resumes & Interview Techniques | Ep.34

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.  Interviewing remains one of those activities which we think we know all about merely because we have been doing it so long; we...

Dr. Keith McCrea: Fighting the Cytokine Storm | Ep.32

Taylor McPartland: Entrepreneurial Recipes for Success | Ep. 31

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 partnership with The Innovation Institute, a nationwide leader in healthcare provider innovation, ...

Marinela Gombosev: Developing Soft Skills in Leadership | Ep.30

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 undergraduate studies in Electrical Engineering at the University of California, Irvine and received...

Andrew Lyon: Leadership Beyond the Classroom | Ep.29

Warren Foust: Leadership Through Authenticity | Ep.28

Kevin McNerney: Where Everyone Knows Your Name | Ep.27

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 issues, driving community engagement, and the lack of a strategic plan, among other traits.  One ...

Nested Knowledge: The Currency of Science | Ep.26

Dr. Ali Tinazli: Quick Turn Diagnostics | Ep.25

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 h...

Dave Ferrera: Innovation in Translation | 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,...

Richard Oberreiter: New Frontiers in Vascular Health | Ep. 23

Jill Bigelow: Reshaping the Healing Experience | Ep.22

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 entrepreneurial spirit, she set out to design a product for modern mamas that helped them heal their bodies ...

Patrick Johnson: Turning Passion Into Purpose | Ep.21

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 unique devices founded on NASA-developed technology and backed by clinical studies, that convenie...

Ram Rao: Vision with 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 som...

Raymond Cohen: Persevering in OC Medtech | Ep.19

Mike Mussallem, CEO Edwards Lifesciences: 2019 Podcast Recap | Ep.18

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 aired in August of 2019 you’ll want to make sure to listen in now.

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 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 s...

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 lowering the cost of medical care given the increasing costs of using animal tissue valves and the associated durability and calcification concerns.  The proprietary biopolymer materia...

Kwame Ulmer: Advancing Diversity in Medtech | Ep.15

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 to scale themselves at the same rate as the business? In this episode of DeviceAlliance’s Medtech Radio, we speak with the Vice P...

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 County is projected to increase by 18% over the next decade, as cancer risk increases with age and the county’s population is aging faster than the U.S. average. In thi...

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 to building quality into their processes as a differentiator? How does one understand and stay ahead of the FDA and EU changing quality regulations as leaders instead...

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 impairment, and the corresponding treatment needed to optimize recovery?  In this episode of DeviceAlliance’s Medtech Radio, we speak with Chief Clinical Officer of SyncThink, Inc. and M...

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 episode of DeviceAlliance’s Medtech Radio, we speak with the Executive Vice President of the Greater Irvine Chamber of Commerce, Linda D...

Travis Smith: DeviceAlliance, Future Forward | Ep.9

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

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.