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Welcome to the "Speaking of Wealth" podcast showcasing profit strategies for speakers, publishers, authors, consultants, and info-marketers. Learn valuable skills to make your business more successful, more passive, more automated, and more scalable. Your host, Jason Hartman interviews top-tier guests, bestselling authors and experts including; Dan Poynter (The Self-Publishing Manual), Harvey Mackay (Swim With The Sharks & Get Your Foot in the Door), Dan Millman (Way of the Peaceful Warrior) ...
 
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show series
 
Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible. In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP o…
 
It's easy to get so wrapped up in the risk management of your medical device that you forget about managing your business risk with the same level of diligence and ongoing attention. In this episode of the Global Medical Device Podcast, Jon Speer talks to Michael Cremeans, Life Sciences Industry Practice Leader at Hylant. Together, Mike and Jon tal…
 
"And she remakes the wedding dress, and I don't know how she does this, but out of that material she's able to make a top hat." Josh comes back to represent redheads and we talk three ginger movies! 0:00 -- Intro (Josh, vax news, Oscar news) 7:54 -- The Quiet Man 30:06 -- Betsy's Wedding 49:10 -- Zero Dark Thirty 1.19:10 -- Awards and rankings 2.08…
 
Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice? The waterfall methodology used to be the industry norm for medical device product development until an alternative approach known as the agile methodology emerged, leading to competing opinions over which product development approach is best. In this specia…
 
Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me!” While it may not be everyone’s favorite pastime, internal audits are very important...especially if you have or want a true quality culture and mindset of continuous improvement. In this episode of the Global Medical Device Podcast, Jon Speer talk…
 
What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a medical device? In this episode of the Global Medical Device Podcast, Jon Speer talks to Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS). Jon and Milton discuss practical pointers for determining and describing th…
 
For medical device professionals, there are the “knowers” and the “doers.” One group is knowledgeable about quality best practices and product realization needs, but may not know how, or have the desire, to act upon it. The other group puts that knowledge into action by doing the best practices that are needed to realize the product needs and [seiz…
 
"That's his thing -- he likes to eat cities and princesses." Three or four years of anticipation are satisfied as we finally speak of Greek tales thousands of years old (or at least from the Italian Film Commission 67 years ago). Andy from Kiss Your Franchise Goodbye completes his required double stint of servitude. Also, as a special guest our old…
 
Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, are you a customer who has benefited from using them? In this episode of the Global Medical Device Podcast, Jon Speer talks to Alison Lee about her PPE startup Breathe99, which pivoted operations in developing its high-quality face mask product to meet…
 
Do you fear needles and the associated pain? No one understands this fear more than physicians who see it firsthand with their patients day in and day out. And one physician in particular set out to do something about it. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dr. Amy Baxter, CEO and founder at Pain Care Labs. Amy …
 
The one person you have the most trouble forgiving is yourself. Yet much of the way we think and act was learned before we reached the age of 10. Randy Gage, author of the new book Radical Rebirth, joins Jason Hartman to discuss how we can constantly reinvent ourselves to become the best version we can possibly be. Key Takeaways: [1:30] Randy's on …
 
Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a different purpose, but are all three actually necessary? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about FDA’s three systems of risk for medical devices and the uni…
 
How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD manufacturers approach quality management and other key elements based on these similarities and differences? In this episode of the Global Medical Device Podcast, Jon Speer talks to Joanne LeBrun from MDC Associates, which offers quality systems co…
 
"What cuddly animal is killed when your hands are full too often?" Andy from Kiss Your Franchise Goodbye is back with an Italian vendetta and three movies that made him the cuddly man he is today. They're pretty alright movies. 0:00 -- Intro (Andy is back, near picks) 14:53 -- A Hard Day's Night 53:35 -- The Godfather: Part II 1.36:03 -- Your Name.…
 
Does your medical device qualify for an investigational device exemption (IDE)? What does this process involve and what does FDA expect of these manufacturers? There is plenty to consider when it comes to the IDE timeline and process. In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill “Mr. Regulatory” who sheds v…
 
Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself? There’s a supplier management solution that will make your job a whole lot easier. In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-owner of ‎QUNIQUE, a quality and regulatory consultancy. Previously, …
 
Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that has historically been known to evoke a fearful, negative response by medical device professionals. In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, known in the industry as Mr. Regulatory, about the reasons why t…
 
Why is design, manufacturing, quality, and culture so important in the medical device industry? These key elements must exist and function in synchrony so that a medical device can save and improve patient lives. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dan Purvis, CEO at Velentium—a design, development, and manufact…
 
What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices from FDA? How is STeP different from similar programs, like the Breakthrough Devices Program? Which devices are eligible? In this episode of the Global Medical Device Podcast, host Jon Speer and his guest Mike Drues from Vascular Sciences offer answer…
 
"Is that the most 80s thing ever? To be married to Robert Wagner?" Mark joins again. Death and laughter ensue with three movies where the star died before filming completed. This unlithe podcast runs over three hours, so hopefully you have a real boring workday goin' on right now. Hey how did we not pick North Carolina as best recurring character? …
 
One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical device gurus ⁠are a team of medical device professionals with decades of combined industry experience and subject matter expertise. In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenligh…
 
What does it take to build a successful MedTech startup? It’s a multi-million dollar question and the answer involves strong execution of a highly strategic plan. In this episode of the Global Medical Device Podcast, Jon Speer talks to Duane Mancini, president and founder of Project Medtech, and host of the Project Medtech Podcast. Listen as Jon an…
 
What makes Greenlight Guru unique? It’s Guru Edge⁠—a team of medical device professionals with a ton of industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Karen Schuyler, a Medical Device Guru at Greenlight Guru with nearly 15 years of experience working in the medical device industry. Listen as Karen offe…
 
Jason Hartman talks with the author of 17 great books, Jeffrey Gitomer. Jeffrey's latest book, Go Live!, is a salute to mastering the virtual world and exuding comfort on video. If you don't master virtual and you don't master video, someone else will. Jeffery, the self-branded 'king of sales,' gives top tips from his book on how to be a thought le…
 
Imagine using medical illustrations, animations, and other types of artwork to tell the story of a medical device, its procedures, or its manufacturer. In this episode of the Global Medical Device Podcast, Jon Speer talks to Annie Campbell and Emily Holden from Now Medical Studios, where they create medical illustrations and animations for the heal…
 
Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are interested in entering the SaMD space, what do you need to know when it comes to FDA regulations and guidance? In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, “Mr. Regulatory”, who has nearly a decade of firstha…
 
How can medical device companies be better prepared for remote and on-site inspections or audits? Practice, practice, practice so that you’re always audit-ready. In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry, lead consultant and senior advisor for Quality Systems and Compliance, respectivel…
 
The new medical device regulation in the European Union (EU MDR) has introduced a host of new challenges for medical device companies. One challenge, in particular, has to do with the quality management system of a medical device. In this episode of the Global Medical Device Podcast, Jon Speer talks to Monir El Azzouzi, founder and CEO of Easy Medi…
 
"It was as overwhelming as, like, Dorothy Gish complimenting you?" Josh Fillmore is back to talk about movies with title colors spanning the rainbow! We go from red to white and then all the way back to red! Dancing! Crime wife abuse! Nuclear subs! 0:00 -- Intro (Josh is back, brrrr, the podcast cost) 7:23 -- The Red Shoes 30:40 -- White Heat 55:28…
 
Nick Loper of Side Hustle Nation joins Jason Hartman to discuss three different business models, from sales to services, everything from knife sharpening to pooper scooping. Build a side hustle to fund your vacation or fund your next investment property. Nick Loper is host to a podcast and author of a couple of books. His creative approach to build…
 
What do auditing and compliance protocols look like during a pandemic? Medical device companies continue to adjust to changing circumstances in an attempt to maintain business as close to normal as possible. In this episode of the Global Medical Device Podcast, Jon Speer talks to Colleen Hittle, founder of ProVeritas Partners, who brings years wort…
 
Keeping a constant pulse on current medical device industry standards for risk management, like ISO 14971:2019 and its companion documents, while also adhering to the recommended guidelines is one of the most important things a medical device company can do to be successful.In this episode of the Global Medical Device Podcast, Jon Speer talks to Ed…
 
"It's his severance meat." Josh comes back with his personal three movies that made him the man he is today. Incidentally, he's now a boxing French lawyer. Also big apologies for dealing with some real heavy material and then getting all frivolous as usual about it because that's what we know. 0:00 -- Intro (Josh is back, movie intro, Roy's AMC mem…
 
Medical device reimbursement is a key consideration that must be well researched, understood, and managed by companies in order to ensure no money, to which you’re entitled to, is left on the table.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the importance of medical device reimbu…
 
Medical device design reviews - are more or less better?What about independent reviews? Are they necessary? How do you get one done?These are a few of the topics we touched upon in episode 3 of the Global Medical Device Podcast, How To Improve Your Medical Device Design Reviews. And they seem to have struck a nerve. That’s why today, we’re excited …
 
If you're like many in the medical device industry, you've probably had some questions at one time or another around the FDA's Design Control Guidance.And if you're anything like the guests on today's podcast, you've probably gone through a lot of trial and error trying to implementing them.Wouldn't it be nice if some industry vets were willing to …
 
Superbugs. Reprocessing.The White House.And Design Controls.Probably not a combo of topics you see grouped together very often.But we have them all for you on today’s Global Medical Device Podcast.This is the 2nd edition in our series focused on Design Controls and related topics within the Medical Device Industry. During this episode, we’ll surfac…
 
With nearly half a century of combine experience performing medical device Design Reviews between them; Michael Drues Ph.D., Jason McKibbin, and Jon Speer have the battle scars they want to help you to avoid.They peel back the lens on what has worked for them over the years and how you can implement their proven strategies at your organization.Desi…
 
Risk management for medical devices from a regulatory and product development perspective is the topic of today’s podcast. We take a look at a few tools to help in the process and liability as it relates to on-label vs off-label use (Some really interesting points on this topic). We suggest following the ISO 14971 standard which provides manufactur…
 
In today’s episode of the Global Medical Device Podcast Jon Speer welcomes Sara Naab to the show. Sara is the co-founder and director of quality and marketing for Sandstone Diagnostics. Sara shares with us insights into what it’s been like going from idea, to raising funding, to being name one of the 40 most innovative life sciences companies in th…
 
What are the most common mistakes a startup medical device company usually make?Hear Ronny Bracken candidly disclose how to avoid some very expensive lessons when starting out in the medical device business.With his 26 years of Research and Development experience for medical product development at the executive level, he will show us how to avoid a…
 
On today's episode of the Global Medical Device Podcast, we’re discussing how startup entrepreneurs like you can remove the common regulatory obstacles your business faces and other tips and pointers you can use when developing new medical devices.Our guest today – Mitch Levinson – is the CEO of Cerebrotech Medical, and with over 30 years experienc…
 
We’ve got a good one for you today. In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascular Sciences. As many of our listen may recall, Mike does consulting for medical device companies, the FDA, Health Canada and other regulatory bodies.Today Jon and Mike talk about 510(k)s and some of the major mist…
 
In episode 9 of the Global Medical Device Podcast we’re joined by Mike Cremeans. Mike is the Vice President in the Healthcare and Life Sciences practice at Willis (the third best insurance broker in the world). His main function is that of a risk strategist, for FDA regulated organizations worldwide. He also is the man behind Willis’ Life Sciences …
 
In episode 10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt is a project manager for the Azzur Group and has been involved with many medical device projects. He was a founding employee and executive team member at GluMetrics, a venture-backed startup that raised over $67M. Matt has 20 years experience in the …
 
If you are in the business of medical devices, then you must eat, breathe, and live quality management systems. In order to get to market and sell your products successfully, your quality system needs to be right-sized, and meeting all of the regulations can be one of the hardest hurdles to cross in this business.Our guest today is here to talk abo…
 
Did you know ISO 13485 has been revised and approved in 2016?And is going to be published later this month.The quality management standard we’ve all grown to know is now being updated, and we’ll explain more on this episode of the Global Medical Device podcast.Today we’re joined by special guest, Mark Swanson. In addition to being a consultant for …
 
Standards are absolutely critical when you are developing a medical device.You need to understand why these standards are important when developing your product for your regulatory submission. You need to know what they are and understanding how to incorporate them as part of your design and development process at the beginning rather at the end.To…
 
Another brilliant mind joins us today on the Global Medical Device Podcast. Peter Sebelius is the founder of Gantus.com and today we’ll talk medical device product development and project management. Peter is a certified PM and has vast experience in the industry and extensive knowledge of medical device standards. He is also a member of the joint …
 
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