The healthcare system is broken. Open Door Salon is a place where patients can find an easier way to navigate treatment—and where those working within the system can come together to solve the problems they hear about every day. Change starts with conversation.
Open Door Salon
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23 episodes
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Podcast Overview
The healthcare system is broken. Open Door Salon is a place where patients can find an easier way to navigate treatment—and where those working within the system can come together to solve the problems they hear about every day. Change starts with conversation.
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🇺🇲
Publishing Since
1/28/2026
1 verified contact email on file for Open Door Salon
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Recent Episodes
July 8, 2026
The Three Forces That Make or Break a Launch: FDA, Payers & Hackers
<p>This episode is made possible by MedTech World: https://med-tech.world/</p><p><br></p><p>Medtech launches don't fail for one reason. They fail at the FDA, at the payer, or at the firewall. Host Lori Ellis continues a conversation started at MedTech World with Christian Espinosa, Founder and CEO of Blue Goat Cyber, and Edwin Lindsay, Principal Consultant and Managing Director at CS Lifesciences, on all three forces at once: why FDA cybersecurity deficiency letters are exploding, why vibe coding has no place in a regulated device, why China is a signal and not a verdict, and why reimbursement planning that starts after clearance is already too late.</p><p><br></p><p>(00:00) Where medtech launches actually break first</p><p>(01:52) 37 pages of FDA cybersecurity deficiencies</p><p>(03:44) The 180-day clock and what happens when companies miss it</p><p>(06:16) Why vibe coding fails FDA scrutiny</p><p>(08:00) The questions investors should be asking before they write a check</p><p>(10:05) Patient safety, not data protection, is the real cybersecurity question</p><p>(14:00) China, supply chains, and the CMS8000 backdoor</p><p>(20:41) A modified firmware chip and a very bad feeling</p><p>(22:20) What FDA readiness actually means in 2026</p><p>(25:27) The submission delay nobody saw coming five years ago</p><p>(26:45) Why "it's just a Docker container" isn't a defense</p><p>(29:49) When reimbursement strategy should enter product design</p><p>(32:20) The most expensive reimbursement mistake either of them has seen</p><p>(36:36) The hardest professional decision each of them has made</p><p>(40:25) What pulled each of them into healthcare</p><p><br></p><p>Guests: Christian Espinosa, Founder & CEO, Blue Goat Cyber (LinkedIn: https://www.linkedin.com/in/christianespinosa/). Edwin Lindsay, Principal Consultant & Managing Director, CS Lifesciences (LinkedIn: https://www.linkedin.com/in/edwin-lindsay-5a1980/).</p><p><br></p><p>Open Door Salon is the life-sciences podcast hosted by Lori Ellis. Subscribe, and get the free quarterly briefing on Substack.</p><p><br></p>
July 1, 2026
Anna Titkova & Prashant Yadav: When War Stops a Patient's Treatment
<p>Two wars, a pandemic threat, and a regulatory system under strain are hitting global health at the same time. Anna Titkova, who led clinical operations in Ukraine through the invasion, and Prashant Yadav of the Council on Foreign Relations, one of the world's leading voices on healthcare supply chains, join host Lori Ellis on Open Door Salon.</p><p><br /></p><p>They cover what happened to clinical trials and patients when the war stopped shipments into Ukraine, why pharmaceutical supply chains push low- and middle-income countries to the back of the queue, the patients the market never sees, the erosion of confidence in the US FDA, China's very different model of health diplomacy, the global health funding gap, and why reform is not the same as dismantling.</p><p><br /></p><p>(00:00) Intro — two wars, a pandemic, and a system under strain</p><p>(00:56) Clinical trials under fire: lessons from Ukraine</p><p>(04:28) Why supply chains push vulnerable patients to the back of the queue</p><p>(06:17) Inclusive research, or retreat to the safest places?</p><p>(08:24) Regulatory instability and the eroding confidence in the FDA</p><p>(12:40) Is the global community actually coming together?</p><p>(14:57) Ukraine's healthcare supply chains and Europe's response</p><p>(18:45) "The market doesn't see them"</p><p>(21:27) Can China fill the void? A different model</p><p>(25:16) Making care findable for displaced patients</p><p>(27:28) Entrepreneurs, young people, and reforming global health</p><p>(29:47) Reform is not the same as dismantling</p><p>(32:01) The hardest decisions, and what drives them</p><p><br /></p><p>Guests: Anna Titkova, MD, PhD, MBA, Clinical Research Site Network Leader at Pratia (previously led clinical research operations in Ukraine); and Prashant Yadav, Senior Fellow at the Council on Foreign Relations.</p><p><br /></p><p>Open Door Salon is the life-sciences podcast hosted by Lori Ellis. Subscribe, and get the free quarterly briefing on Substack.</p><p><br /></p>
June 24, 2026
Theresa Campobasso: The Regulatory Wave Reshaping China Biotech Deals
<p>New US rules are reshaping how pharma and biotech can do deals with China, and BIOSECURE was only the start. Theresa Campobasso, Senior Vice President at Aardwolf Global and a former US Marine Corps intelligence officer, returns to Open Door Salon to read the regulatory signals with host Lori Ellis.</p><p><br></p><p>They cover what the BIOSECURE Act actually restricts, why it's an early signal rather than the finish line, the likely next targets (APIs, raw materials, precursors), the USITC investigation into Chinese state subsidies, and the proposed COINS Act that would put US investment, licensing, and joint ventures in Chinese biotech under government review. Plus why existing deals may not be grandfathered in, the specific ways IP gets stolen, what the 28% concentration of top pharma deals in Chinese biotech means now, the medtech and hardware angle, and how to read where the regulation goes next.</p><p><br></p><p>(00:00) Intro — why China regulation matters now</p><p>(00:22) The China update: what just changed</p><p>(01:04) What the BIOSECURE Act actually covers (the 5 named companies)</p><p>(02:10) Why BIOSECURE is an early signal, not the finish line</p><p>(03:29) The next targets: APIs, raw materials, chemical precursors</p><p>(05:32) The USITC investigation + the COINS Act explained</p><p>(09:08) Does this hinder innovation? The window to act now</p><p>(10:35) Will existing China deals be grandfathered in?</p><p>(13:31) The different ways your IP actually gets stolen</p><p>(15:52) 28% of top pharma deals are China — now what?</p><p>(18:49) Medtech, counterfeit hardware, and the Warp Speed catch</p><p>(21:56) How to read where the regulation is headed next</p><p><br></p><p>Guest: Theresa Campobasso — SVP, Aardwolf Global; former US Marine Corps intelligence officer. LinkedIn: https://www.linkedin.com/in/theresa-campobasso-02b78b56/</p><p><br></p><p>Open Door Salon is the life-sciences podcast hosted by Lori Ellis. Subscribe, and get the free quarterly briefing on Substack.</p>
23 total episodes available
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Frequently asked questions
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- What is Open Door Salon?
- How often does this podcast release new episodes?
This podcast updates daily.
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This podcast is available on 4 platforms including Apple Podcasts, Spotify, and more. You can also use the RSS feed directly.
- Does this podcast accept guests?
Yes, this podcast regularly features guests.
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