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.
9 Sep 2019
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 of followers? In this episode of DeviceAlliance’s Medtech Radio, we speak with Founder of Greenlight Guru, Jon Speer. Join us as he shares his deep insights in the differences that help medical devices get to market faster with less risk. Greenlight Guru is the only quality management software platform designed specifically for medical devices companies. The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more.
4 Nov 2019
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 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.
20 Jan 2020
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 President and General Manager Neurovascular with Medtronic, Stacey Pugh. With over 16 years in medical device, Stacey has served several key leadership roles, including Vice President, Global Medical Affairs, Neurovascular with Covidien and Sr. Director, Global Clinical Development with Kinetic Concepts. Join us as Stacey shares her personally journey from her background as a nurse at the patient's bedside, to becoming a key leader of the fast growing business division of Medtronic.
2 Dec 2019
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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 DiMario. Linda has over thirty years of sales, marketing and leadership experience in the tourism industry and economic development sphere. Join us as she shares the the Chamber's action plans to bring global medical device companies to Irvine by leveraging its diversity, innovative prowess, and collaborative strength!
7 Oct 2019
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 goal that drives you. This can be anything, such as reaching the top of your company or even raising a family. Whatever your goal may be, the idea is that having something to aim for will help you put your best foot forward day after day. In this episode of DeviceAlliance’s Medtech Radio, we interview Jeff Blanton of the Blanton Group. The Blanton Group focuses on transforming the potential of a business by discovering and implementing the combination of business and personal purpose. Join us for an in depth discussion on the keys to success, and how to marry one's desires, strengths, and passions with the collective goal of the business.
12 Aug 2019
Raymond Cohen: Persevering in OC Medtech | Ep.19
17 Feb 2020
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 is, and she is the recipient of our first DeviceAlliance Woman STEM Scholarship Award. In this episode of DeviceAlliance’s Medtech Radio, we interview Joanne Ly. She serves as Multimedia Director and Associate Editor at GPS-Biomed and is a doctoral student at UCI.
26 Aug 2019
Ryan Blackmore: People Strategies | Ep. 3
Welcome to the 3rd episode of the DeviceAlliance podcast. In this episode, Scott Johnson speaks with Ryan Blackmore about the important role HR plays in driving business results and success for medical device companies. Please subscribe and leave a review on iTunes if you've liked the show so far. Enjoy!
1 Jul 2019
Travis Smith: DeviceAlliance, Future Forward | Ep.9
23 Sep 2019
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 this episode of DeviceAlliance’s Medtech Radio, we speak with the President, City of Hope Orange County, Annette Walker. She served as president of strategy for Providence St. Joseph Health and chief executive of St. Joseph Health. In 2017 she was named one of the top 25 women in U.S. healthcare by Modern Healthcare magazine. Join us as we discuss her professional journey in health care, the challenges fighting cancer today, and how the medical device community can help in that fight.
18 Nov 2019
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.
3 Feb 2020
David Powell: Leadership Lessons | Ep.4
Welcome to the 4th episode of the DeviceAlliance podcast. In this episode, Scott Johnson speaks with David Powell about the lessons he's learned from his leadership roles in the medical device industry and insights on how to be an effective leader. Resources: Good to Great Built to Last David's LinkedIn
15 Jul 2019
Kwame Ulmer: Advancing Diversity in Medtech | Ep.15
16 Dec 2019
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 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.
21 Oct 2019
Omnica Corporation: Orbiting Medical Product Development | Ep.5
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 perils of being first in a ever fast paced market of innovation.
29 Jul 2019
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 material and design of the Tria heart valves also allows 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 ground breaking 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 have the potential to revolutionize the heart valve industry.
6 Jan 2020
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 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.
11 May 2020
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, 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".
27 Apr 2020
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 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, Jill Bigelow. 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.
30 Mar 2020