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Ken Reali has gained significant and varied experience in his 33-year MedTech career. He has individually contributed and then led areas including product development, global marketing, business development, commercialization, and sales of medical devices. He has a strong background in ethics and compliance, market analysis, reimbursement strategy, regulatory and clinical affairs, new product development, sales force optimization and domestic and international product commercialization. Ken has also been successful in utilizing M&A to diversify and broaden companies and has successfully led financing at both private and public companies. As a CEO for 13 years, Reali has gained experience driving strategies to build shareholder value. He has worked with and led initiatives with medical societies, patient advocacy groups, governmental agencies, public and private insurance companies, investor relations, capital funding, strategic planning, and quality and lean production. He has led companies through sales processes to new ownership and into public markets through IPO. Reali started his career at two large multi-national companies, Biomet and Stryker where he held positions of increasing responsibility. Ken then gained general management experience at Smith & Nephew starting in 2006 prior to taking on his first CEO role in 2010 at TranS1 driving a turnaround strategy. Reali then led Clinical Innovations, a women's healthcare company through successful exit after five years while doubling the business size and value. In 2020 he led Bioventus through an IPO while increasing the size of the business by 80% through strategic M&A. Reali serves on the board of directors of a broad group of companies in MedTech from orthopedics to women's healthcare. Reali also donates his time serving on the board of directors of AdvaMed, the National Italian American Foundation, and Valparaiso University College of Business. Ken lives in Walla Walla, Washington with his wife Kristin where they started a vineyard several years ago.
In today's episode, I sit down with Dr. Peter Bonutti to talk about the ways in which technologies are revolutionizing our understanding of the brain, and how they may be used to treat crippling brain disorders such as stroke and seizures. Dr. Peter Bonutti, M.D. is a surgeon, inventor, author, professor, consultant, and entrepreneur. He is the founder of Bonutti Research, a medical device incubator that has developed products and technology used around the world. He maintains his clinical and surgical practice, focusing on the integration of robotics into surgical procedures. He is the founder and president of Releave, a company whose technology has already been clinically proven in more than 700 patients for the treatment of a brain related disorder. Realeve's ultimate goal is to solve one of the critical remaining barriers in brain health: the ability to bypass the brain's natural barrier preventing the delivery of effective drugs for stroke, cancer treatment, and other degenerative orders. Dr. Bonutti is a pioneer in Minimally Invasive Surgery, has over 500 patents and applications, more than 700 licenses and multiple FDA-approved products to date. Major corporations leveraging his technology include Hitachi, Kyphon, Covidien, US Surgical, Biomet, Arthrocare, Synthes, Zimmer/Biomet and Stryker. He is a prolific speaker, lecturing internationally, and has trained over 100 surgeons on his surgical techniques. In his career, Dr. Bonutti has received more than a dozen industry honors and awards for his achievements. Dr. Bonutti earned his medical degree at University of Cincinnati College of Medicine and completed his Orthopaedic Surgery Residency at Cleveland Clinic Foundation with international fellowships in Canada, Australia, and Austria.
His journey and talents leading him to the company bettering a foundation for the human bone.
Richard Lehman, MD does not let moss grow under his feet. As you will hear in this episode, he is involved in the whole spectrum of sports, but has a special focus on track & field and hockey. He is also an author with a new book underway and a previous book: How to Raise an Athlete (available on Amazon).Dr. Lehman grew up in Miami, Florida. He completed his training at Washington University and the University of Pennsylvania, and completed a sports medicine fellowship in 1986. He was a part owner of the National Hockey League Florida Panthers and has been the team physician for the Florida Panthers, Tampa Bay Lightening and St. Louis Blues. He has been a consulting physician for UCLA Track & Field and has covered four Olympic Games, as well as seven Track & Field World Championships.Dr. Lehman was inducted into the St. Louis Sports Hall of Fame and the Missouri Sports Hall of Fame Class of 2012 and was on the Board of Directors of the Jackie Joyner-Kersee Youth Foundation, the medical director of Webster Surgery Center and the medical director of the U.S. Center for Sports Medicine. He has served on the Board of Governors for the National Hockey League and is on the St. Louis Sports Commission. His practice encompasses taking care of professional athletes at all levels and all sports, as well as Division college athletes.Dr. Lehman has revolutionized cartilage regeneration techniques working in conjunction with Biomet to further growth and reconstruction of articular cartilage. He has written and lectured extensively on the subject, and has written three books on tennis injuries. He has published extensively in orthopedic literature and sports medicine. He is licensed in Missouri and California. He actively takes care of Track & Field athletes from all over the world and professional athletes from North America.
Technology is in a constant state of change, especially with new innovations in healthcare happening every day. But it's not always easy to know what's out there, or to get your product to market. In today's connected world, it has become more important than ever to have a community that you can chat with, learn from, and bounce ideas off of. Networking is in. But how do networking events in healthcare bring value to the industry?On the latest episode of I Don't Care with Host Kevin Stevenson, guest Hays Waldrop, Founder and President of the Institute of Healthcare Executives and Suppliers, discusses the foundation of IHES and the importance of networking in the healthcare field. Waldrop's ‘Aha!' moment came when he was working with a start-up in healthcare that had a product catered towards those with learning disabilities. While the doctors and healthcare professionals loved the product, so too, did schools. So when he saw the superintendents and leaders of school districts gathered to network and chat about different products, he had a realization: why wasn't this happening in healthcare?So, over the course of 20 years, Waldrop networked to form a conglomerate of healthcare professionals. “We've got a CEO group, I've got a supply-chain group, and also a pharmacy group, and so we come together and it's a live-event business and we connect providers and suppliers in this environment.”The two also discussed…1) The different events IHES holds and how it creates a positive learning environment2) What type of sessions and networking events there are and who attends3) What the criteria are for adding in newer suppliers and start-ups“You know, if you're just the same old ‘me too' commodity, that's not real attractive necessarily, they're necessary and yeah we clearly have those…but it's always cool when you have a new technology, something different that the executives perhaps have not seen before or maybe they're doing it just differently…,” said Waldrop. Hays Waldrop has over 25 years of experience in the healthcare industry, having first started working in Territory Sales for Biomet, an orthopedic implant company. After working with a few start-ups around the dot com boom, Waldrop formed IHES, a group of three networking and learning platforms for healthcare executives and suppliers. He is a graduate of the University of Tennessee, Knoxville.
In this episode of GODMODE™: Win or Win Bigger, William Lam and Brady Edwards discuss with Dr. Arup Sen the biotechnology side of health and nutrition to improve the min and create a better body and soul.Dr. Sen has 35+ years in research and executive management positions at biotechnology and pharmaceutical companies, negotiated and managed licenses and joint ventures with J&J, Biomet, GCC, Tokuyama Soda of Japan, Eastman Kodak, and Sandoz/Novartis.His work during the past decade led to the invention of proprietary technologies that produce unique water-soluble minerals, and micronutrients, including phytochemicals. Arup was awarded a Ph.D. in biochemistry from Princeton University and is a former faculty member at the National Cancer Institute (Bethesda, Maryland) and at the Scripps Research Institute (La Jolla, California) focused on cancer research.Dr. Sen is the inventor of five (5) US patents and numerous international patents and pending patent applications in the fields of cancer therapeutics, bone repair biologics, and devices and diagnostics.---HIGHLIGHTS:How biotechnology side of health and nutrition can improve the mind and ultimately create a better body and soulThe process of healthy agingWhy should you be interested in the new formulation of supplementation?---TIME STAMPS:00:00 - Prelude1:15 - Introduction to Dr. Arup Sen04:00 - Introduction to the biotechnology side of health and nutrition to improve the mind and create a better body and soul06:45 - Combine the strength and beauty of the body with the upgrading of the mind and create a better humanity 10:30 - Target what can be done and that is by developing supplements13:00 - The different types of formulations in the making19:00 - Where did the formulation of the supplements begin?24:00 - The process of healthy aging31:00 - Why should people be interested in the new formulation of supplements35:45 - How do we know the dosage of what to take to fully optimize our bodies?37:30 - Who will benefit more from this supplementation?47:00 - What will be the goal for the formulation and technology for the supplementation?53:30 - What do people need to do to prepare for this technology?01:03:00 - How can you invest in this biotech project?01:07:35 - How will this technology benefit mankind?01:10:58 - ENDThank you for listening to GODMODE™: Win or Win BiggerIf you are interested in UPGRD Your Mind, visit us at: https://upgrd.com to book a call with one of our team members.
Rural health clinics and critical access hospitals seek to provide care for those living in underserved areas. With the increase in public health concerns, sometimes these organizations require help to meet their community's needs. This week we welcome back Kate Hill, the Vice President of the Clinical Division with the Compliance Team. Kate will update us on her work with rural health clinics and critical access hospitals along with how the Compliance Team continues to help these organizations navigate their changing environment. “We put a certification together to verify and validate the good work that our critical access hospitals do in swing beds in their hospital” -Kate Hill Kate Hill, RN, is a graduate of Albert Einstein Medical Center School of Nursing in Philadelphia, PA. As an Army Nurse, Kate served in Viet Nam (27th Surgical Hospital in Chu Lai) where she was awarded the Bronze Star for meritorious service. Kate has worked with orthopedic patients in several capacities including Head Nurse of Orthopedics in Newark, NJ., followed by Biomet working in various capacities. Kate joined The Compliance Team (TCT) in early 2012 to direct TCT's rural health clinic accreditation program and has fallen in love with Rural. As VP of Clinical Services, she has spearheaded the TCT Rural Health Clinic Accreditation program combining her clinical expertise, business acumen, and passion for delivery of the best care possible to every patient. She presently serves on the Board of the National Association of Rural Health Clinics. Kate also works with clinics in TCT's PCMH program and is ensuring that a PCMH accreditation is being increasingly rewarded by payers.
In this week's episode, we interview Shawn McCormick. Shawn has 30 years of financial expertise and operational experience in the medical device and life sciences industry. Most recently, he was the Chief Financial Officer of Aldevron, a private equity-backed CDMO. Shawn joined Aldevron in 2020 and remained until February 2022, following the sale of the company to Danaher, Inc. in 2021. He served as the Chief Financial Officer of Tornier N.V. and Tornier, Inc. from September 2012 until the completion of the merger with Wright Medical in October 2015. He also served as Tornier's Principal Accounting Officer. Mr. McCormick served as Chief Operating Officer of Lutonix Inc. from April 2011 to February 2012, when Lutonix was sold to C.R.Bard. He served as Chief Financial Officer and Senior Vice President of ev3, Inc. from January 2009 to July 2010 and as its Principal Accounting Officer. ev3 was sold to Covidien in July 2010. Mr. McCormick held various positions of increasing responsibility at Medtronic, Inc. from 1992 to 2009, including Vice President of Corporate Development from May 2008 to January 2009 and Vice President of Finance for the Spinal, Navigation, and ENT business from 2002 to 2007. He has been a Director of Nevro Corp. since September 2014 and Inspire Medical Systems Inc. since January 2017. He also served on the board of Surmodics, Inc from December 2015 to December 2020 and the board of Entellus Medical from December 2014 to February 2018, when Entellus was sold to Stryker. Mr. McCormick serves as the Audit Committee Chair for both Nevro and Inspire and previously for Entellus. He also served as a Surmodics' audit committee and governance and nominating committee member. Mr. McCormick served on the board of LANX from August 2010 to November 2013, serving on the Compensation Committee and Audit Committee before LANX was sold to Biomet in November 2013. Mr. McCormick is a Certified Public Accountant (non-active license). He holds a B.S. in Accounting from Arizona State University and an M.B.A. from the University of Minnesota's Carlson School of Management.
Oral Arguments from the Eighth Circuit U.S. Court of Appeals
Oral argument argued before the Eighth Circuit U.S. Court of Appeals on or about 09/21/2022
Two weeks ago, we shared the top ten most listened to RHLR episodes ever! Number two on that list was Episode #103 a Conversation with Kate Hill. This week we're highlighting that episode with Kate Hill and listening back to her story. “Our motto is actually safety, honesty and caring.” ~Kate Hill Kate Hill, RN, is a graduate of Albert Einstein Medical Center School of Nursing in Philadelphia, PA. As an Army Nurse, Kate served in Viet Nam (27th Surgical Hospital in Chu Lai) where she was awarded the Bronze Star for meritorious service. Kate has worked with orthopedic patients in several capacities including Head Nurse of Orthopedics in Newark, NJ., followed by Biomet working in various capacities. Kate joined The Compliance Team (TCT) in early 2012 to direct TCT's rural health clinic accreditation program and has fallen in love with Rural. As VP of Clinical Services, she has spearheaded the TCT Rural Health Clinic Accreditation program combining her clinical expertise, business acumen and passion for delivery of the best care possible to every patient. She presently serves on the Board of the National Association of Rural Health Clinics. Kate also works with clinics in TCT's PCMH program and is ensuring that a PCMH accreditation is being increasingly rewarded by payers.
We are excited to have on good friend and supporter and advocate of our industry, Tony Prestipino from Artifex Dental Laboratory (https://artifexlab.com/). Tony comes on to talk about how he learned about the profession, having a brother who is a prosthodontist and another bother in the lab business, getting into implants, and taking an All-on-X procedure and patenting the procedure. It's hard to find anyone so willing to help anyone willing to ask. Information and how to register for the Race For the Future 8.0 August 28th (https://dentallabfoundation.org/news-events/race-for-the-future/) Information and registration for the Chicago Triathlon (https://www.chicagotriathlon.com/) Register for the FREE Education Day on August 27th (https://dentallabfoundation.org/education-day/) (COME TO THE DINNER!) Donate to Barb or Team Voices From the Bench!!!! (https://fdlt.memberclicks.net/donor-form#!/) Whip Mix (https://www.whipmix.com/)'s new VeriWhirl (https://www.whipmix.com/products/veriwhirl-dental-3d-printed-parts-cleaner/?product=technical_resources) resin cleaning station is the ideal piece of equipment to use in the 3D printed resin post process. It's oscillating, multi-speed stirrer produces a tornado-like vortex every 30-seconds, and guarantees efficient, effective and powerful cleaning whether the units are individual or still attached to the build plate. The two alcohol baths make an effective step-wash system. It cleans more efficiently and there is less alcohol needed, since it is re-used for both a fresh bath and a dirty bath. The VeriWhirl's intelligent design offers features such as Mode, Time, and Start/Stop button display which gives the operator full and automatic control of the cleaning process. A mesh basket used in the wash container makes it easy to keep track of small printed parts when cleaning. The affordable unit's one-year warranty ensures peace-of-mind for the owner. Visit whipmix.com (https://www.whipmix.com/) or call (800) 626-5651 for more information about this great new product. ExoCAD is excited to present their next Insights event October 3-4, 2022, on the sun-drenched island of Mallorca, Spain. Learn how DentalCAD (https://exocad.com/our-products/exocad-dentalcad?utm_campaign=Insights%202022&utm_source=Introtext%20Insights%20sub%20page%20EN&utm_medium=DentalCAD%20product%20web%20page%20EN&utm_term=link), ChairsideCAD (https://exocad.com/our-products/exocad-chairsidecad?utm_campaign=Insights%202022&utm_source=Introtext%20Insights%20sub%20page%20EN%20ChairsideCAD&utm_medium=ChairsideCAD%20product%20web%20page%20EN&utm_term=Link) and exoplan (https://exocad.com/our-products/exoplan?utm_campaign=Insights%202022&utm_source=Introtext%20Insights%20sub%20page%20EN%20exoplan&utm_medium=exoplan%20product%20web%20page%20EN&utm_term=link) can streamline and improve workflows. Connect with friends and colleagues in the industry while collecting CE points* during a full program of software education, partner shows and international guest speakers. Enjoy the exclusive welcome party, featuring fantastic music and food. Join us in making Insights 2022 an event to remember! Register at exocad.com/insights2022 Did you know Asiga (https://www.asiga.com/) has over 500 validated materials on their open material system. And it's growing everyday? By harnessing Asiga's proprietary layer monitoring technology with its smart positioning system and integrated internal radiometer, as a laboratory, you will be able to produce any indication you desire. Whether models, splints, temporaries, or even permanent crowns. Your investment will be future proofed by Asiga's rugged engineering. Providing you with a fast, accurate, and repeatable machine, with a reputation that is time tested in the laboratory industry. If you would like to learn about Asiga's machine or material offerings, please visit the website at asiga.com or contact your favorite dental reseller. Special Guest: Tony Prestipino, CDT.
Oral Arguments from the Eighth Circuit U.S. Court of Appeals
Oral argument argued before the Eighth Circuit U.S. Court of Appeals on or about 04/13/2022
Warriors! This hour we've got one of the Doc's favorite guests! Mark Bezjak from Biomet. They discuss all things hip replacements and destiny. The world of fate and sports. The exam room is still open, and there's some guy named Bob Dylan you might've heard of that we'll talk about as well. tune in for all that and more! Learn more about your ad choices. Visit megaphone.fm/adchoices
Dr. Talia Nutting has provided exceptional dental care in Knoxville since 2009. She has studied extensively on implant restoration at the Zimmer Implant Institute and with Biomet's Synergy Program. Dr. Nutting has received intensive training on Cerec CAD/CAM technology, which allows the office to offer crowns in one day. She is also a member of the prestigious Kois Center in Seattle, Washington. Dr. Nutting grew up just down the road in Kingston, Tennessee. She was a hygienist for 3.5 years and then went on to study at the University of Tennessee, earning high honors at the College of Dentistry. Dr. Nutting went to work as an associate at a practice in Knoxville, until she was convinced to buy a practice that was about 70% HMO. After a divorce 2 years into ownership, Dr. Nutting pretty much gave up everything but her practice and started over. She got off the HMO and got involved in airway. Dr. Nutting and her husband Marshall, along with their two children, reside in West Knoxville. When not at the office, you can find her lending support to her children's school and sports activities and making a point to hear great live music. She loves hot tea, coffee and the Rolling Stones.
In this special Veteran’s Day episode of Rural Health Leadership Radio, we're talking with Kate Hill, RN. Kate is a US Army Veteran and Bronze Star Recipient, awarded in recognition of meritorious service in a combat zone while serving in Viet Nam. You may know her as Vice President of Clinical Services with The Compliance Team. Here is what Kate had to say about receiving the Bronze Star: “I was humbled beyond belief… I was overwhelmed because there were so many more deserving, particularly men, who served in the jungles in great peril… And so frankly, I was shocked… It reads meritorious service in a combat zone, and that it was. I spent many nights in a bunker…” ~Kate Hill, RN Kate Hill, RN, grew up outside of Philadelphia and is a graduate of Einstein Medical Center School of Nursing. As an Army Nurse, Kate served in Viet Nam where she was awarded the Bronze Star. Kate has worked with orthopedic patients in several capacities including nearly 3 decades with Biomet in various capacities. Kate joined The Compliance Team in early 2012 to direct TCT’s rural health clinic accreditation program and has fallen in love with Rural. As VP of Clinical Services, she has spearheaded the TCT Rural Health Clinic Accreditation program combining her clinical expertise, business acumen and passion for delivery of the best care possible to every patient. She presently serves on the Board of the National Association of Rural Health Clinics. She feels fortunate to have been able to speak at numerous state and national meetings about RHC compliance countrywide which gave her the opportunity to learn firsthand the diverse regional issues clinics are facing. Kate also works with clinics in TCT’s PCMH program and is seeing that a PCMH accreditation is being increasingly rewarded by payers. Kate lives in suburban Philadelphia with her husband and near her three granddaughters.
His journey and talents leading him to the company bettering a foundation for the human bone...
Doc opens talking about the duality mobility of opposites in sports, art and medicine. Doc uses the examples of Tony Bennett, William 'Refrigerator' Perry, and guest Adam Horoho, Biomet. The Weekend Warrior Clinic opens for listeners. Learn more about your ad choices. Visit megaphone.fm/adchoices
Doc continues in the Cedars-Sinai Studios and retells his thoughts about the duality mobility of opposites in sports, art and medicine. Doc welcomes Adam Horoho who talks about the medical technological advances of Dual Mobility at Biomet. The Weekend Warrior Clinic re-opens for listeners. Learn more about your ad choices. Visit megaphone.fm/adchoices
The #AI Eye: Baidu (NASDAQ: $BIDU) Launches Robotaxi Trials in Changsha and Nuance (NASDAQ: $NUAN) Wins Alconics Award for AI-Powered Biometrics Tech
The #AI Eye: Baidu (NASDAQ: $BIDU) Launches Robotaxi Trials in Changsha and Nuance (NASDAQ: $NUAN) Wins Alconics Award for AI-Powered Biometrics Tech
The #AI Eye: Baidu (NASDAQ: $BIDU) Launches Robotaxi Trials in Changsha and Nuance (NASDAQ: $NUAN) Wins Alconics Award for AI-Powered Biometrics Tech
The #AI Eye: Baidu (NASDAQ: $BIDU) Launches Robotaxi Trials in Changsha and Nuance (NASDAQ: $NUAN) Wins Alconics Award for AI-Powered Biometrics Tech
Show Description: Bob Vitoux leads the investing activities for the Ambassador Capital Group in the Ambassador Enterprises private equity business. Prior to joining Ambassador, Bob served as the President & CEO of Seymour Midwest, a privately held landscape and specialty tool manufacturer, and was the CFO for Steinway Musical Instruments. The majority of his career has been in the medical device industry, including commercial and finance leadership roles with Zimmer, Johnson & Johnson, and Biomet, following the start of his career in public accounting with Price Waterhouse. In this interview Bob walks us through his professional journey in the medical device industry, his company leadership roles later in his career, and important life lessons he has learned in the areas of leadership, people development, and self-investment. Show Highlights: 4:10-13:40: Bob highlights his professional journey, especially through the finance realm of the medical device industry, experiencing a company acquisition, and eventually becoming the CEO of a landscape tool company called Seymour Midwest. 13:40-31:10: *Bob discusses his passion for, and the landscape of, the medical device industry. He describes learning through a variety of different relationships with internal employees and stakeholders, and the importance of becoming a student of your company. *31:10-41:40: Bob goes into the challenges that are present at the CEO or top-executive. He walks through his process and motivations toward making impactful decisions for the companies he leads. 41:40-59:10: Bob describes the difficult decision to leave the medical device industry, his CFO leadership role at Steinway & Sons, a piano company in New York, and communicating with his family from long distance while experiencing the piano and music industry. 59:10-1:06:10: We ask Bob how he developed himself as a leader, important characteristics to lead people, and the influence that mentors have made on him throughout his career. *1:06:10-1:20:10: *Bob explains his leadership program with Ambassador Capital Group, and his partnership with Remedy Live to help improve mental health in communities and lower teenage suicide rates. He gives advice to parents on how to continue to remain engaged in children's lives. *1:20:10: *Bob gives critical concluding advice to those who are still in the process of finding their ideal career path. Special Guest: Bob Vitoux.
Martin is Founder and CEO of Americord Registry, a company that preserves umbilical cord blood stem cells on behalf of expectant mothers. They ranked for the past three years as one of the fastest growing private companies in the United States. Before founding Americord, Martin was an investment banker in Healthcare and Healthcare Technology at BMO Capital Markets. Martin worked in investment banking at Wells Fargo Securities, and also at American Capital (Private Equity) and NewMarket (Venture Capital). He did work in the healthcare sector as well for Biomet, now Zimmer Biomet. Martin received an MBA from American University and graduated from the University of Maryland with a degree in Biology. Main Topics: Building A Purpose Driven Organization Differentiation & Scaling Becoming A Learning Machine
This week we’re having a conversation with Kate Hill, Vice President of Clinical Services with The Compliance Team. “Our motto is actually safety, honesty and caring.” Kate Hill, RN, is a graduate of Albert Einstein Medical Center School of Nursing in Philadelphia, PA. As an Army Nurse, Kate served in Viet Nam (27th Surgical Hospital in Chu Lai) where she was awarded the Bronze Star for meritorious service. Kate has worked with orthopedic patients in several capacities including Head Nurse of Orthopedics in Newark, NJ., followed by Biomet working in various capacities. Kate joined The Compliance Team (TCT) in early 2012 to direct TCT’s rural health clinic accreditation program and has fallen in love with Rural. As VP of Clinical Services, she has spearheaded the TCT Rural Health Clinic Accreditation program combining her clinical expertise, business acumen and passion for delivery of the best care possible to every patient. She presently serves on the Board of the National Association of Rural Health Clinics. Kate also works with clinics in TCT’s PCMH program and is ensuring that a PCMH accreditation is being increasingly rewarded by payers. Kate lives in suburban Philadelphia with her husband and near her three granddaughters. She’s happy to share photos anytime.
The call, email or tip comes into your office; an employee reports suspicious activity somewhere across the globe. That activity might well turn into a Foreign Corrupt Practices Act (FCPA) issue for your company. As the Chief Compliance Officer (CCO), it will be up to you to begin the process which will determine, in many instances, how the company will respond going forward. This month’s podcast series will provide to you all the steps you will need to consider going forward. This scenario was driven home in a FCPA enforcement action brought by the Securities and Exchange Commission (SEC) in July 2015 involving Mead Johnson Nutrition Company (Mead Johnson). In that case, the company performed two internal investigations into allegations that its Chinese business unit was engaged in conduct which violated the FCPA. Unfortunately the first investigation, performed in 2011 did not turn up any evidence of FCPA violations. It was not until 2013, when the SEC made an inquiry to the company that it performed an adequate internal investigation which uncovered FCPA violations. Similarly, consider Zimmer Biomet, which (when it was only Biomet) resolved an FCPA violation in 2012 for nearly $23MM and entered into a Deferred Prosecution Agreement (DPA). Within the year, Biomet notified its Monitor that it has found evidence of additional FCPA violations, which in turn violated the terms and conditions of the DPA. However these additional violations by the company (now Zimmer Biomet) turned out to have been actions which occurred in 2010, well before the initial DPA but were not uncovered in the company’s worldwide investigation which led to the first settlement. Zimmer Biomet paid an additional $13MM for this oversight and extended out both the DPA and the Monitorship, all because the company had failed to fully investigate itself thoroughly. The 2012 FCPA Guidance states the following on investigations, “Moreover, once an allegation is made, companies should have in place an efficient, reliable, and properly funded process for investigating the allegation and documenting the company’s response, including any disciplinary or remediation measures taken.” That is simply it. This simple introduction was expanded upon in the Justice Department’s Evaluation of Corporate Compliance Programs (Evaluation) released in February. Prong 7 in the makes the following inquiries: Effectiveness of the Reporting Mechanism – How has the company collected, analyzed, and used information from its reporting mechanisms? How has the company assessed the seriousness of the allegations it received? Has the compliance function had full access to reporting and investigative information? Properly Scoped Investigation by Qualified Personnel – How has the company ensured that the investigations have been properly scoped, and were independent, objective, appropriately conducted, and properly documented? Response to Investigations – Has the company’s investigation been used to identify root causes, system vulnerabilities, and accountability lapses, including among supervisory manager and senior executives? What has been the process for responding to investigative findings? How high up in the company do investigative findings go? The Mead Johnson and Zimmer Biomet matters are but two examples which make clear the need to have robust, integrated investigations. Marc Bohn, writing in the FCPA Blog, said about the Mead Johnson matter, “Investigations that lack sufficient depth, resources, or forethought can pose significant risk because they increase the likelihood that something critical will be overlooked, potentially permitting misconduct to continue unabated.” Both Mead Johnson and Zimmer Biomet point to the critical nature of FCPA investigations and why the government takes this requirement so rigorously. But more than protecting a company from liability under the FCPA, in the internationalized world of global compliance investigations are becoming more important. Bio-Rad recently announced that its FCPA settlement was a “risk-factor” which required public disclosure under US securities law. In the domestic arena, internal investigations can go a long way towards helping a company move past a public relations debacle or perhaps abate negative publicity. One need only consider the recently released internal investigation report commissioned by the Wells Fargo Board of Directors around the bank’s fraudulent accounts scandal. The report was merciless in its criticism of certain structural and cultural failures at the bank. It named names of culpable former senior executives at the company. However one thing it did not address were allegations from multiple whistleblowers who claimed to have reported the fraudulent conduct and were ignored or actively retaliated against. If the internal investigation turns out to have white washed these whistleblowers, the financial penalty and negative public reaction could be both swift and severe. Corrupt investigations are never a good thing for a company as they can disrupt business relationships and future opportunities. Yet today they are even more important. In the month of June I will be exploring how you can create, design and implement a robust investigation protocol for an internal investigation and when you should bring in outside counsel for an independent investigation. I will consider the Board of Director’s role in investigations and other corporate functions such as internal audit, IT and legal in any investigation. I will review special issues such as privilege, Upjohn and Miranda warnings and data privacy. As Hallmark Seven of the Ten Elements of an Effective Compliance program states, in part, “An effective compliance program should include a mechanism for an organization’s employees and others to report suspected or actual misconduct or violations of the company’s policies on a confidential basis and without fear of retaliation” and Prong 7 of the Evaluation also deals with reporting; I will consider hotlines. Both their implementation and use in a best practices compliance program. I will feature several compliance practitioners, both lawyers and non-lawyers, who will relate how they developed their investigative strategies and navigated various stakeholders to obtain positive results for their clients. Three Key Takeaways Failure to thoroughly and properly investigations allegations of corruption can be costly. The internationalization of global anti-corruption enforcement makes performing robust investigations even more important. Use the month of June to learn about key aspects of investigations and internal reporting mechanisms. Learn more about your ad choices. Visit megaphone.fm/adchoices
Dr. Nate Farley is an outright nerd who found his passion in dentistry. He practices as a Prosthodontist at Gundersen Health Systems in Southwestern Wisconsin. He is originally from Northern California, completed his undergraduate degree at BYU before heading east to attend dental school at The Ohio State University, and stayed at OSU for his prosthodontic residency. There, he earned a Masters of Science with his thesis challenging the accuracy of CAD/CAM surgical guides against traditional guides used for implant placement. A couple of years into practice, he received board certification in Prosthodontics. As a true nerd, he loves to push the boundaries of digital dentistry through use of intraoral scanning, 3D modeling, virtual wax ups and implant planning, and in-office 3D printing. He taught himself web development while in his undergrad, created an online forum for his dental class to discuss concept and share files, co-created dentaltoons.com in dental school, co-created whatimplantisthat.com in his residency, and continues to build online dental resources through Infodontics, LLC, which he co-founded with Dr. Kent Howell. Outside work, Dr. Farley loves to hike, ride bikes, and build Legos with his wife and 3 kids. Dr. Kent J. Howell is a Prosthodontist who maintains a specialty practice limited to Prosthodontics in Mesa, AZ. Dr. Howell attended Case School of Dental Medicine in Cleveland, OH and then completed a 3 year prosthodontic residency at The Ohio State University. During his residency, he earned an M.S. degree in the study of dental implants where his thesis challenged the accuracy of a new cad/cam technology called the Encode system from Biomet 3i. He is also the co-founder of Infodontics LLC, and co-creator of whatimplantisthat.com. Whatimplantisthat.com is a free online resource to aid in the identification of dental implants all over the world. There are over 900 implants found on the site and it has been available online since 2010. It was the inspiration for the FIRST mobile app for dental implant identification in the world, created and launched in 2013. Dr. Howell loves to play golf, restore smiles, and spend time with his family. www.WhatImplantIsThat.com
About Dr. Steven Goldstein: Education & Background Dr. Steven Goldstein attended dental school at Georgetown University, and received three additional years of training at the University of Pennsylvania in their periodontal/prosthesis program. He opened his practice in Scottsdale, Arizona in 1990. Areas of Expertise Restorative and cosmetic dentistry, including dental implants, crowns, veneers, bridges, full-mouth restorations and dentures. Dr. Goldstein also performs simple procedures such as fillings, cleanings and teeth whitening. National Lecturer Dr. Goldstein lectures nationally on implant dentistry, dental digital photography and digital asset management and is a Key Opinion Leader (KOL) and dental implant speaker for BIOMET 3i, a global dental implant company. He has presented his lectures across the U.S. at many important national dental conferences. www.StevenHGoldsteinDDS.com
From to to for stem cell injections that would be illegal in the USA, it seems that stem cells are the hot new arrival on the recovery and anti-aging scene. I distinctly recall my first experience with injecting cells into the human body. I was a young, bright-eyed hip and knee surgical salesman, and the company I worked for at the time (Biomet) had just developed a post-surgical procedure called Platelet Rich Plasma (PRP). This PRP process involved collecting and then centrifuging a patient's blood to separate the platelet-poor plasma and red blood cells.The platelets are concentrated about five-fold, and then re-injected into the wound site to speed up healing. I later thought this was such a cool process for other issues, like knee and elbow pain, that I partnered with a physician to purchase a PRP machine for treating the athletes and clients who I worked with, many of whom had uncanny and "miraculous" injury and inflammation reversals. But compared to PRP, stem cells are a whole new animal, and in this podcast with my guest , we dive into the legality, the conflicts, the long-term health the potential for doping, the alternatives, the costs and much more. Shawn (pictured right) is a bestselling author and creator of The Model Health Show, which is often featured as the #1 Health podcast in the country on iTunes. A graduate of The University of Missouri - St. Louis, Shawn studied biology and kinesiology, and went on to be the founder of Advanced Integrative Health Alliance, a company that provides wellness services for individuals and organizations worldwide. Shawn has been featured in Men's Health magazine, Entrepreneur magazine, ESPN, FOX News, and many other media outlets. During our discussion, you'll discover: -The crazy story of how Shawn's hip broke while he was running, and the broken medical system that nearly destroyed his entire gut while fixing his hip... -How Shawn regenerated his spine, which doctor's told him was "the spine of an 80 year old man"... -The four different types of stem cells, and which ones work best for killing pain, healing injuries and decreasing inflammation... -The two surprising ways you can find and harvest stem cells without using embryos... -How new human body parts can literally be regrown after being injured... -How Shawn skipped any blood centrifuging, bone marrow injections or stem cell therapies and instead used specific foods to increase stem cell growth in his own joints... -The exact ingredients of Shawn's most potent medicinal tea recipe... -Why both Ben and Shawn stuff mushrooms into vodka bottles... -And much more! Resources from this episode: - - - - - (and ) - - - - Do you have questions, comments or feedback about stem cells, stem cell therapy, alternatives to stem cells and how stem cells work? Leave your thoughts, comments and feedback at .
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
What do Stryker, Biomet, Medtronic, and Boston Scientific all have in common? Yes, they all manufacture medical devices. But more specifically, all four of these medtech companies have implantable device divisions. And from 2005 – 2011, the implantable device segment has been the most consistent top performer relative to other categories including: in vitro diagnostics...[read more]Related StoriesSocial Media Best Practices for Marketing Medical DevicesAre Medical Device Models the Key to Building a Lean Medtech Startup?Can Nurep Solve the Inefficiency Problem in Medical Device Sales?