Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.
…
continue reading
What’s the best way to deal with ISO internal audits? Keep calm, follow a consistent approach, and consider ample time for preparation. This is only a brief account. When it comes to ISO 13485 Standard, you need to understand the complexities of the standard before performing the internal auditing program. If you are responsible for planning and executing internal audits for your organization, you might know how much planning and effort is required to monitor a Quality Management System or Q ...
…
continue reading
The Power House podcast brings the biggest names in housing to answer hard-hitting questions about industry trends, operational and growth strategy, and leadership. Join HousingWire president Diego Sanchez every Thursday morning for candid conversations with industry leaders to learn how they’re differentiating themselves from the competition. Hosted and produced by the HousingWire Content Studio.
…
continue reading

1
Global Medical Device Podcast powered by Greenlight Guru
Greenlight Guru + Medical Device Entrepreneurs
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
…
continue reading
With the effective CAPA management system, you can resolve quality issues, improve customer satisfaction, ensure the compliance with the standards and regulatory requirements, identify and implement improvements. CAPA management software of Qualityze helps the manufacturers to integrate with the other processes that consists of the audit, nonconformance, document management, change control and also the customer responses. Read more - https://www.qualityze.com/capa-management/
…
continue reading

1
Jason Bressler: UWM levels the playing field with Sphere LOS
24:23
24:23
Play later
Play later
Lists
Like
Liked
24:23This week on Power House, Diego sits down with a familiar face to the HousingWire audience — Jason Bressler, the Chief Technology Officer at United Wholesale Mortgage. UWM recently announced its partnership with Sphere LOS, and today’s episode is a behind-the-scenes look at what that means for the UWM team and beyond. Diego and Jason talk about the…
…
continue reading

1
Fifth Third Bank is all about the (mortgage) lending life
31:57
31:57
Play later
Play later
Lists
Like
Liked
31:57This week on Power House, Diego sits down with Jay Plum, a 35-year banking veteran and the EVP of Consumer Lending at Fifth Third Bank. As the 10th largest bank servicer in the country, Fifth Third Bank has over a thousand branches and $200 billion in assets. Today’s conversation is all about mortgage lending. Jay and Diego talk about Basel III and…
…
continue reading

1
Marketing automation is the future — and Fello wants to help
38:07
38:07
Play later
Play later
Lists
Like
Liked
38:07This week on Power House, we are bringing you a special sponsored conversation between HousingWire’s Director of the Content Studio, Zebulon Lowe, and the CEO and co-founder of Fello, Ryan Young. Founded in 2022, Fello is a marketing automation and lead-generation CRM attachment that uses public and MLS data to enrich your database and improve enga…
…
continue reading

1
#399: How To Approach Culture Differences
22:41
22:41
Play later
Play later
Lists
Like
Liked
22:41In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Olga Chashchina, a MedTech startup founder with extensive international experience. They explore how cultural differences affect communication in the medical device industry and the importance of understanding intercultural nuances. Drawing from the book The C…
…
continue reading

1
eCTD 4.0 & Medical Devices: What's Happening in 2025?
16:46
16:46
Play later
Play later
Lists
Like
Liked
16:46Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs. For the first episode, I’m joined by Diarmuid Waide, regulatory expert, and Sean Carpenter, Product Manager. We discuss the latest eCTD 4.0 news and a recent MHRA consultation on Medical Devices. Know what’s comin…
…
continue reading

1
How daily accountability and coaching is fueling Windsor Mortgage's growth
21:59
21:59
Play later
Play later
Lists
Like
Liked
21:59This week on Power House, Diego chats with Windsor Mortgage CEO Chris Vinson. After his company, Journey Mortgage, was acquired by the South Dakota-based Plains Commerce Bank, Chris joined the Plains Commerce team to head their growing mortgage division. He and Diego talk about how Windsor is differentiating itself from other wholesale competition …
…
continue reading

1
#398: Game-Changing Connections in MedTech: Inside LSI with Scott Pantel
35:52
35:52
Play later
Play later
Lists
Like
Liked
35:52In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Scott Pantel, CEO and founder of Life Science Intelligence (LSI), to explore how LSI bridges the gap between medtech innovation and commercialization. Scott shares LSI’s origin story, the evolution of its events, and the importance of cultivating meaningful re…
…
continue reading

1
NAR’s plan to build back trust with Sherry Chris
25:27
25:27
Play later
Play later
Lists
Like
Liked
25:27On this week’s episode of Power House, Diego talks to Sherry Chris, the special advisor to National Association of REALTORS CEO, Nykia Wright. Sherry retired from her role as Anywhere Expansion Brands president and CEO in 2023, but now she’s back to offer her unique perspective and advice on some of the current challenges that the industry is facin…
…
continue reading

1
#397: Winning Over Skeptics: the Key to Product Adoption in Healthcare
33:12
33:12
Play later
Play later
Lists
Like
Liked
33:12In this episode, Etienne Nichols sits down with Tiffany Ryder—healthcare advocate, physician assistant, and founder of Red Flag Hero—to discuss the complexities of product adoption in healthcare. Tiffany shares her journey from rural Louisiana to the NFL cheerleading squad and into emergency medicine, highlighting how personal experience shapes her…
…
continue reading

1
Discovering non-QM’s potential with Deephaven’s Tom Davis
27:03
27:03
Play later
Play later
Lists
Like
Liked
27:03This week on the Power House podcast, Diego sits down with Tom Davis, the chief sales officer at Deephaven Mortgage. Deephaven has been a pioneer in the non-QM space since its founding in 2012, and Tom joins us today to talk about all things non-QM and 2025 market growth. Deephaven’s non-QM focus accounted for $70 billion in 2023 and is expected to…
…
continue reading

1
Newrez’s roadmap for client retention with Baron Silverstein
31:38
31:38
Play later
Play later
Lists
Like
Liked
31:38This week on the Power House podcast, Diego sits down with Baron Silverstein, the president of Newrez. Baron joined the Newrez team in May of 2020 and has over 30 years of industry experience with senior roles at Bear Stearns, JP Morgan Chase, Merrill Lynch, and Bank of America Securities. With a total unpaid principal balance of $750 billion, Newr…
…
continue reading

1
Inside Lower’s landmark year: Dan Snyder reflects on 2024
29:18
29:18
Play later
Play later
Lists
Like
Liked
29:18This week on Power House, Diego sits down with Dan Snyder, the CEO of Lower. This past year was a busy year for Lower amid their acquisition of both Neat Labs and Thrive Mortgage. Back in July of 2024, we welcomed Lower’s Chief Strategy officer, Craig Montgomery, to give us the low-down on Lower’s plan to become a top-five mortgage lender. Today, D…
…
continue reading

1
Varun Krishna shares Rocket’s plan to “become the Apple of homeownership”
30:56
30:56
Play later
Play later
Lists
Like
Liked
30:56This week on Power House, Diego sits down with Varun Krishna, the CEO of Rocket Companies. Prior to joining Rocket in 2023, Varun came up on the personal finance and enterprise software side of the tech space, with roles at Intuit and Paypal. Rocket has a growth plan to make home ownership easier, enjoyable, and sustainable for homeowners. Diego an…
…
continue reading

1
How Prosperity Home Mortgage Became #1 in Customer Satisfaction
30:20
30:20
Play later
Play later
Lists
Like
Liked
30:20This week on the Power House podcast, HousingWire president Diego Sanchez sits down with Justin Messer, the CEO of Prosperity Home Mortgage. Prosperity was recently ranked at the top mortgage originator for customer satisfaction by JD Power. Today — with that top ranking in mind — Justin and Diego talk about Prosperity’s strategic shift from refina…
…
continue reading
Happy Holidays from Power House and the entire team at HousingWire! We have some exciting conversations planned for 2025, so we'll see you in the New Year! If you have any feedback or comments about the show, please reach out at [email protected]. The Power House podcast brings the biggest names in housing to answer hard-hitting questions about ind…
…
continue reading

1
Frank Martell talks loanDepot’s journey to profitability
34:05
34:05
Play later
Play later
Lists
Like
Liked
34:05This week on the Power House podcast, HousingWire President Diego Sanchez sits down with loanDepot president and CEO, Frank Martell. Frank, who was a 2016 and 2023 HousingWire Vanguard Awardee, brings to the table over 30 years of mortgage and executive leadership experience. Today’s conversation is all about loanDepot’s return to profitability in …
…
continue reading

1
#396: Mastering Device Descriptions: The Cornerstone of Medical Device Submissions
50:33
50:33
Play later
Play later
Lists
Like
Liked
50:33In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory consultant Mike Drues delve into the often-overlooked yet critical topic of device descriptions in FDA submissions. Discover why this foundational element can determine the success of your regulatory pathway, influence classification, and impact the required testin…
…
continue reading

1
Behind the scenes of Guild’s “customer-for-life” strategy
30:41
30:41
Play later
Play later
Lists
Like
Liked
30:41This week on the Power House podcast, Diego chats with industry veteran and Guild Mortgage CEO Terry Schmidt. Terry joined Guild in 1985 and she stepped into the CEO role in 2023. Terry and Diego talk about Guild’s proprietary AI system, Guild IQ, and how Guild’s recent acquisitions are a step toward growing their reverse presence. They also talk a…
…
continue reading

1
#395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond
42:04
42:04
Play later
Play later
Lists
Like
Liked
42:04In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development. They unpack the upcoming revisions to the fourth edition of IEC 60601, focusing on the rationale behind these changes, their impact on medical device design, an…
…
continue reading

1
#394: Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike Drues
51:18
51:18
Play later
Play later
Lists
Like
Liked
51:18In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices. They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the…
…
continue reading

1
Building balance with Mr. Cooper’s Jay Bray
23:35
23:35
Play later
Play later
Lists
Like
Liked
23:35This week on the Power House podcast, Diego sits down with Jay Bray, the CEO of Mr. Cooper. Jay joined Nationstar in 2000 and brings over 25 years of mortgage serving and origination experience. They discuss Mr. Cooper’s growth and acquisition strategy, specifically the Flagstar acquisition, which brought Mr. Cooper's servicing book up to $1.5 tril…
…
continue reading

1
#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko
33:48
33:48
Play later
Play later
Lists
Like
Liked
33:48In this episode of the Global Medical Device Podcast, Etienne Nichols talks with Justin Bushko, president of Concise Engineering and founder of MedTech Man. Justin shares his extensive experience in MedTech, guiding startups and major players alike through complex engineering challenges. From simplifying prototypes to pivoting product strategies, J…
…
continue reading

1
Humans over homes with NextHome CEO James Dwiggins
37:43
37:43
Play later
Play later
Lists
Like
Liked
37:43This week on the Power House podcast, Diego sits down with James Dwiggins, the CEO and co-founder of national real estate franchise, NextHome. Guided by a “humans over homes” philosophy, the brand focuses on quality over quantity, with 600 offices and 6,000 agents across the country. James has a lot of experience in the real estate world, and with …
…
continue reading

1
#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell
58:38
58:38
Play later
Play later
Lists
Like
Liked
58:38In this engaging episode of the Global Medical Device Podcast, Etienne Nichols and Devon Campbell dive into the complexities of verification and validation (V&V) in medical device development. Whether you’re a medtech startup founder or an industry veteran, this conversation offers essential insights on creating robust V&V processes. Devon shares p…
…
continue reading

1
Real value: How Class Valuation is redefining AMCs
29:04
29:04
Play later
Play later
Lists
Like
Liked
29:04Today on the Power House podcast, we are bringing you a special sponsored conversation between Zeb Lowe, the director of HousingWire’s Content Studio, and Andrew Bough, the COO at Class Valuation. Andrew is joining us today to share how Class Valuation is setting new quality standards for appraisals through approaches such as their appraiser scorec…
…
continue reading
This week on Power House, Diego chats with industry veteran Chad Smith, the president and COO of Better, who stepped into the role earlier this year from Mission Loans. Chad and Diego talk about Chad’s decision to join the Better executive team and what they’re working on to help grow Better in 2025, which includes a focus on customer engagement an…
…
continue reading

1
Daren Blomquist: Rethink your post-pandemic benchmarks
32:14
32:14
Play later
Play later
Lists
Like
Liked
32:14This week on the Power House podcast, Diego sits down with Daren Blomquist, VP of Market Economics at Auction.com. Daren is a friendly face to many of you, and was last on the show in early 2023 to discuss his 2023 forecast. He’s joining us again to talk about what he expects to see in the market post-election and into 2025. He and Diego talk about…
…
continue reading

1
#391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq
35:58
35:58
Play later
Play later
Lists
Like
Liked
35:58In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Adnan Ashfaq, a seasoned quality, regulatory, and validation specialist, to explore the critical role of developing a regulatory roadmap for medical device companies. Adnan breaks down the differences between a regulatory strategy and a regulatory roadmap, highligh…
…
continue reading

1
Ginger Bell and Fobby Naghmi’s guide to leading through tough times
30:02
30:02
Play later
Play later
Lists
Like
Liked
30:02This week on the Power House podcast, HousingWire president Diego Sanchez sits down with the co-authors of the recently published real estate and mortgage guidebook, “Leadership Matters.” Fobby is also the SVP of Homecomings Mortgage & Equity, and Ginger is the founder of Edumarketing. In today’s episode, they talk about why top performers don’t al…
…
continue reading

1
#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli
37:14
37:14
Play later
Play later
Lists
Like
Liked
37:14In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by quality and regulatory expert Ashkon Rasooli to explore the essentials of creating a high-impact, non-burdensome Quality Management System (QMS). Ashkon shares his four guiding principles for building an effective QMS—emphasizing quality over proceduralism, cult…
…
continue reading

1
Inside FirstTeam’s billion-dollar growth strategy with CEO Michele Harrington
25:04
25:04
Play later
Play later
Lists
Like
Liked
25:04This week on the Power House podcast, Diego sits down with Michele Harrington, CEO of FirstTeam Real Estate out of Orange County, California. Michele initially started her career in the Marine Corps, but after being stationed in Orange County, she not only fell in love with the beauty of Southern California, she also got bit by the entrepreneurial …
…
continue reading

1
#389: Pre-determined Change Control Plans
44:10
44:10
Play later
Play later
Lists
Like
Liked
44:10In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues discuss FDA's new framework, the Predetermined Change Control Plan (PCCP), designed to streamline change approvals for medical devices. Originally developed for AI-based devices, the PCCP framework is now available for all types of medical devices…
…
continue reading

1
Jeff Bell: Four pressing topics as you prepare for MBA Annual
40:57
40:57
Play later
Play later
Lists
Like
Liked
40:57This week on the Power House Podcast, HousingWire CEO Clayton Collins sat down with loan originator turned software executive: Jeff Bell, President at Uplist. Jeff joins us to talk about four really pertinent topics in today’s market: leadership, learning, loan monitoring, and recapture. Uplist just launched what it says is a killer new tool that w…
…
continue reading

1
#388: Elements of an Effective CAPA Program
38:35
38:35
Play later
Play later
Lists
Like
Liked
38:35In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Georg Digel, a seasoned expert in Corrective and Preventive Action (CAPA) systems. Georg shares insights into setting up an effective CAPA program, discussing essential topics like identifying CAPA triggers, executing root cause analysis, and implementing corrective actions…
…
continue reading

1
The art of giving back with Fairway CEO Steve Jacobson
29:36
29:36
Play later
Play later
Lists
Like
Liked
29:36This week on the Power House Podcast, HousingWire president Diego Sanchez sits down with Steve Jacobson, CEO of Fairway Independent Mortgage to talk about what it takes to build a company culture centered around humility and loyalty. Diego and Steve also talk about Fairway’s retail growth after their decision to exit wholesale, their plan to sell t…
…
continue reading

1
#387: The case for Real World Evidence Studies
29:06
29:06
Play later
Play later
Lists
Like
Liked
29:06In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation. Simon breaks down NEST's critical role in catalyzing the use of RWE to stre…
…
continue reading

1
Greg Schwartz: A love letter from the salt mines
50:04
50:04
Play later
Play later
Lists
Like
Liked
50:04This week on the Power House Podcast, Clayton sat down with Tomo CEO and co-founder Greg Schwartz to talk about what’s transpired in his business over the last two years — both the good and the bad. They dive into recovery indicators and the investments they’re making in technology and AI. They also talk about how embracing accountable leadership a…
…
continue reading