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 plan coming out of the pandemic, to ensure our medical device community is not only a hub of talent and innovation for California, but for the world? In this episode of DeviceAlliance’s Medtech Radio, we speak with the President and CEO at Greater Irvine Chamber of Commerce, Destination Irvine and Irvine Economic Development, Bryan Starr.  Join us as we discuss the efforts the Irvine Chamber is making to support the medical device community, their initiatives to attract foreign medical device companies to relocate to Irvine, as how we as a community can engage in local efforts to ensure the thriving success of medical device industry. 

DeviceAlliance: MedTech Radio

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

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 Works in The Real World" as we discuss...   - Consideration for the problem you are trying to solve - Big Questions to answer for Clinical Literature, IP Landscape, Stakeholder and Value Proposition, What is relevant today - Pre-clinical / Clinical Testing Feasibility - Planning the Clinical Trial Design – Tactical and Strategic Considerations  - Regulatory Pathway & Business Strategy - Design Approach and policy level considerations - The External Environment  (Legislative, Healthcare Economics, Orange County Talent, Reimbursement and Market Adoption   Expert Panelists Include:   Dr.  Michael Drues - President of Vascular Sciences & FDA Consultant Jeremy Koehler - Director Of Engineering at NXT Biomedical Vinny Podichetty - VP Clinical & Medical Affairs at JenaValve Technology, Inc.   Anand S. Patel, MD - Chief of Interventional Radiology at Providence Little Company of Mary, Torrance     Free Opinion Disclaimer The views and opinions expressed at this event are those of the panelists and do not necessarily reflect the official policy or position of their respective organizations.   Any content provided by our panelists are of their opinion and are not intended to malign any organization, company, individual or any entity.

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

Hayley Haggarty: Building A Better World | Ep.42

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 leadership to multi-million-dollar business enterprises in Europe, Asia, and the United States, and he has successfully transformed multiple struggling organizations into healthy and thriving businesses. He joined Bioplate as President in 2018, bringing with him an extensive background in sales, business development, organizational learning, and product commercialization. Before joining Bioplate, Thomas served as the Director, Global Talent Management & Learning at Edwards Life Sciences. Prior to Edwards, Thomas held various leadership positions at St. Jude Medical.   Join us as we discuss his life's journey into leadership, his most valuables mistakes, keeping teams motivated in times of crisis, how to handle making unpopular decisions, and key trends in key trends in the global craniofacial fixation market.

Thomas Hopson: Leadership Built to Last | Ep.41

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 research organization (CRO) to monitor, audit, and even manage their trial.  Medical device trials in particular bring complex compliance challenges, so having a CRO with specific expertise in this area can be tremendously beneficial.  How can you be sure you hire a medical device CRO that is committed to ensuring compliance and is as invested in your success as you are?    In this episode of DeviceAlliance’s Medtech Radio, we speak with the Director of Regulatory Affairs at Inari Medical, Sarah Boundy Wong and Vice President Clinical Affairs & Market Dev. at JenaValve Technology, Inc., Vinny Podichetty.  Join us as we discuss the best-shared practices and methodologies for selecting a medical device CRO, where does one find CROs, the biggest selection considerations, and lessons learned from both of their professional experiences.  

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

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 deployment of medically trained employees to support public-health needs.  Forward-thinking firms will need data to respond with new products, services, and operating models that can optimize the shifting landscape of healthcare and Medtech development.   Join us as talk with the CEO & Founder of LSI, Scott Pantel.  In this episode, we discuss the challenges of living in an era of an overabundance of MedTech data and how unique market insights remain an industry challenge. We explore why it's more important than ever for startups and large corporations to make their key strategic decisions based on unique and timely insights.   Learn about covid's impact permanently changing the MedTech landscape, and the new considerations the industry must face to address unmet clinical needs.

Scott Pantel: The Endless Data Challenge | Ep.42

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

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 the wearable medical device market alone is projected to reach $14.41 billion by 2022, according to Markets&Markets Inc.  As Medtech explores opportunities within this business model, this consumerization will forever change how healthcare is delivered and medical device evolve.     In this episode of DeviceAlliance’s Medtech Radio, we speak with the FDA Consultant and President of Vascular Sciences, Dr. Michael Drues.  Join us as we discuss the consumerization of Medtech, defining what is a medical device vs. wellness device with respect to regulation,  the "essence" of these distinctions, interpretation of words, and one's ability to defend them in regulation, "Class 0" devices, and wellness devices impact on the evolution of medical devices.

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

Manisha Dhawan: Plotting Your Medtech Career Course | 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, 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". Follow the great work Dave and team are doing at Quantum Fund OC. Connect with Dave on LinkedIn Dave's Book Recommendation - Iacocca: An Autobiography by Lee Iacocca Thanks for listening! Please share our podcast on LinkedIn, Twitter, and Facebook, and stay tuned for our next episode!

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

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 teams will be forced to reckon with the usual “do more with less while at the same time achieving exponential growth” pressures.  Only this year, there’s more pressure than ever as teams look at how they can make up for lost time and dollars while managing supplier and manufacturing issues and other critical gaps in infrastructure.   Medical device companies have an opportunity to play a role in helping the hospitals solve these challenges that are bigger than the price of the device. By providing needed value-added services and support for hospitals that help address challenges such as infection control, patient throughput, and emergency room wait times, medical device companies can position themselves as indispensable partners. In this episode of DeviceAlliance’s Medtech Radio, we speak with the Founder of Bloom Creative, Svetla Kibota.  Svetla has more than twenty years of experience in the pharmaceutical, medical device, and medical technology sectors. She's managed a breadth of medical brands and spearheaded numerous product launches.  Prior to founding Bloom Creative, she led the marketing and client services teams at Lathian Health, an interactive medical marketing and medical education agency where she helped recruit clinicians to various digital campaigns. Before that, she worked across Europe and the U.S. for Gilead Sciences and Applied Medical Devices, in both marketing and sales roles.  Join us as we discuss... - Essential marketing strategize for Medtech companies - Pivoting from volume to value - The empowered patient model of marketing - Branding for 2021 and beyond - The impact of stories over facts - Optimizing digital communication tools 

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

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 address major unmet needs with next-generation medical technologies. In this episode of DeviceAlliance’s Medtech Radio, we speak with the Co-Founder & CEO of NXT Biomedical, Stan Rowe.  Stan recently retired from Edwards Lifesciences where he was Chief Scientific Officer since 2008 and also served as Corporate Vice President, Advanced Technology.  He joined in 2004 when Edwards acquired Percutaneous Valve Technologies, a company he helped to found in 1999 and served as President and CEO.  Join us as we discuss Stan's life lessons learned in the Medtech industry, including... - What are the biggest mistakes R&D makes - Growing a company in his bedroom to being acquired - Biggest strategic considerations for innovation - Different types of accelerators - Addressing the future of unmet clinical needs

Stan Rowe: The Three Legged Stool | Ep.37

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 2017, 2018 Winner of a Medtech Insight Award: Best Technological Innovation, and a 2019 Finalist for a Medical Design Excellence Award.    In this episode of DeviceAlliance’s Medtech Radio, we speak with the CEO of Axonics, Raymond W. Cohen.  Raymond is an accredited public company director with over 35 years of experience in leading medical-device companies and serving as a board member at a number of private and publicly traded life science companies.  Join us as we discuss his personal journey through medtech leadership as he shares his valuable insights into what it takes to successfully identify market opportunities, create clinical and regulatory strategy, develop viable commercial products, and execute high level strategic planning. 

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

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 their contract packaging partners consider the labeling requirements.  Yet, many downstream quality issues are the result of incorrect labeling and/or ill-conceived quality controls that do not provide the proper monitoring at each stage. These can result in drastic consequences from the US and/or EU regulatory bodies, and more importantly to the health of the patient. If the wrong components are incorrectly labeled or not labeled at all, the negative downstream effects can be considerable.   In this episode of DeviceAlliance’s Medtech Radio, we speak with CEO of Pro-Tech Design and Manufacturing, Pam McMaster, and her son Aaron Swanson President of Pro-Tech Design & manufacturing.  PRO-TECH is a family-owned, full-service FDA and ISO 13485 registered medical device contract manufacturer who specializes in medical device assembly and packaging, laboratory services and custom sewn products.  Join us as we discuss what most medical device companies forget about, defining and optimizing work flow, the importance of your sterilization method to materials selection, how to navigate an audit during a pandemic, and what opportunities have arisen in this new Medtech environment.

PRO-TECH: Designing Workflow | Ep.35

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 have been lulled by habit.  It seems apparent that a modest effort aimed at an analysis of our resume writing and interviewing techniques would yield generous returns.  Even though most jobs don't require smooth-talking skills, getting through the interview often does. In this episode of DeviceAlliance’s Medtech Radio, we speak with SVP of Recruiting and Development for McDermott & Bull Executive Search, Denae Bluthemann.  With 20 years of recruiting experience, she has seen recruiting from all perspectives.  She holds an advisory board role for Project Activate, which is an organization that helps individuals at all levels create a path to their dream job. Join us as we discuss the winning techniques for resume writing and job interviews.  Topics include... -  The most important considerations for virtual interviewing -  Addressing resume job and skill gaps effectively -  Creating a resume with directional focus and results -  Addressing resume job and skill gaps effectively -  Why the first five minutes of an interview is absolutely critical -  How to best position your "selling points" -  The S.T.A.R. method for ensuring interview success -  How to close every interview

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

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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DeviceAlliance: MedTech Radio

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