Podcasts about biocompatibility

Did you know that the metal filling in your mouth essentially functions as an antenna for nnEMFs (i.e. cell phones)? That's not good for your mitochondria.  And if you have a mercury filling, did you know that every time you chew food you are causing mercury vapor to be released that you then breathe in? Think of all the deleterious effects from those two instances along.​​Every time I talk to biological dentists, I am always impressed with just how much our oral cavity impacts our entire system; and today's conversation with brother biological dentists from Smilebody, Dr. Shawn Javid and Dr. Shawn Javid, is another insightful look into how and why we need to be taking our oral hygiene and health more seriously for overall wellness.​​Countless people are dealing with brain fog, cardiac dysfunction, low back pain, hormonal issues and so much more than can be directly tied to an underlying root cause issue in their mouth that has never been considered. Many of the aforementioned issues are "patched up" with drugs, surgeries, and other modalities  — even something like red light therapy  — that may help stem the tide or provide temporary relief, but not attack the root cause of something like a cavitation, infected root canal, metal dental work in the mouth, an infected jaw bone or leaky gums.  The Javid brothers founded their renowned holistic dental practice, Smilebody, in Los Angeles where they have patients that fly in from all over the country because of their impeccable skillset as biological dentists and also because of their unique knowledge base and perspective that allows them to embody a whole-body paradigm versus treating the oral cavity in isolation. Their incorporation of effective, efficacious biohacking modalities also lends their clientele to receiving an unparalleled, comprehensive treatment. ​​If you found the information in today's episode with Dr. Ben & Shawn Javid particularly interesting and/or compelling, please share it with a family member, friend, colleague and/or anyone that you think could benefit and be illuminated by this knowledge. Sharing is caring :)As always, light up your health! - Watch this video on YouTube - Where to learn more from and about Dr. Ben & Shawn Javid:​​InstagramFacebook​​MySmileBody.com​ - Key Points: [00:16] Introducing guests: Dr. Ben Javid & Dr. Sean Javid, biological dentists from SoCal [01:36] The transition from conventional to biological dentistry [02:37] The creation of Smilebody: Integrating biological dentistry with functional medicine [03:26] How Dr. Mike met Dr. Ben through Dr. Dominic Nischwitz [04:02] The evolution of Smilebody into a holistic health & longevity center [05:36] Treating the body as a whole rather than in silos [07:48] Frustration with lack of functional medicine support led to Smilebody's creation [09:33] Breaking down biological vs. conventional dentistry [10:36] Five main focuses of biological dentistry (root canals, mercury toxicity, etc.) [12:26] Understanding the mouth-body connection (meridians, systemic health) [14:45] Three key topics to discuss: • Biocompatibility & toxic load • Mouth-body connection • Oral microbiome [15:55] Biocompatibility: How to determine if a material is safe [16:13] Mercury fillings: Hidden dangers & toxicity exposure [17:46] EMF exposure & its impact on dental materials [18:28] Safe alternatives: Zirconia & porcelain [21:12 ] Root Canals & Infections [22:26 ] Cavitations & Toxicity [23:06 ] Nutrition & Healing [24:49 ] Case Study: Root Canal Infection & Chronic Sinus Issues [26:34] Biocompatible Dental Materials [27:46 ] Systemic Health Improvements Post-Dental Treatment [28:53 ] Dental Meridians & Whole-Body Impact [30:43 ] Oral Microbiome & Gut Health [34:21] Dangers of Conventional Mouthwashes [35:50] Evolution of Dental Health & Weston A. Price Research [37:36] Heavy Metals & Generational Toxic Load [38:28] The Future of Biological Dentistry [38:56] pH & Oral Microbiome Balance [40:33] The Impact of Anaerobic Conditions in the Mouth [41:01] Balancing Oral and Systemic Health [42:19] Eliminating Inflammatory Foods [43:15] Integrating Technology in Biological Dentistry [45:13] Photobiomodulation in Dentistry [48:08] The Role of Everyday Oral Care Technology [51:30] Additional Oral Health Practices [54:00] Importance of Tongue Scraping [55:10] Customizing Oral Health Routines [56:20] Where to Learn More [57:35] Upcoming Speaking Engagements and Events [59:08] Final Message: Living with Passion  - The Illume sonic toothbrush is quickly becoming the favorite tool for improving overall oral health by biological dentists around the world, including Dr. Ben & Dr. Shawn Javid!   For the next week, save 15% on all orders of the Illume toothbrush and add red and blue light to your oral health regimen!Discount code: mysmilepodcast   Shop the BioLight Illume by clicking here! - Dr. Mike's #1 recommendations: Water products: Water & Wellness Grounding products: Earthing.com EMF-mitigating products: Somavedic Blue light-blocking glasses: Ra Optics - Stay up-to-date on social media: Dr. Mike Belkowski: Instagram LinkedIn   BioLight: Website Instagram YouTube Facebook

Send us a textMichel is a multilingual scientist who consults in the Medical Devise industry.Support the show

In this episode, Don Pohl and Sheri Krajewski at NAMSA and Duane Mancini discuss ISO 10993 and biocompatibility testing for medical devices, the history of the standard and how it has evolved, why following the risk-based approach is becoming more important, tips to avoid having your submission delayed with various regulatory bodies across the globe, common mistakes and so much more. Don Pohl LinkedIn Sheri Krajewski LinkedIn NAMSA LinkedIn NAMSA Website Duane Mancini LinkedIn⁠⁠⁠ ⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠ ⁠⁠⁠Project Medtech Website Mittal Consulting Rook Quality Systems Kymanox

I got the opportunity to talk to Dr. Christina Schmidt, professor at the Universit of Florida and inventor of the Avanca Nerve Graft. We talked about a lot of things from how she adapted to different climates, biomaterials, Avanca Nerve Graft, to licensing IP and entrepreneurship. ---------------------------------------------------Thanks to the sponsors:Audible: Use my link for a 30-day free trial: http://audibletrial.com/diamondgoat Newsly: https://newsly.me promo code to receive a 1-month free premium subscription: EARLYMORNING Libysn: https://libsyn.com promo code: DGDubby Energy: https://www.dubby.ggpromo code for 10% off: DIAMONDGOATOpus Clips:  https://www.opus.pro/?via=diamondgoat----------------------------------------------------------------------------------Listen on:Podcast website: https://www.spreaker.com/podcast/dg-early-morning-show--5943922Spotify: https://open.spotify.com/show/0EuhA6WyuerHtVAqcFrFeOPodcast YT channel clips: https://www.youtube.com/@dgearlymorningshowTiktok: @dgearlymorningshowApple Podcast: https://podcasts.apple.com/us/podcast/dg-early-morning-show/id1575451533Amazon Music: https://music.amazon.com/podcasts/f050b86c-1dad-4bc3-b12f-6aa5fa62438c Goodpods: https://goodpods.com/podcasts/dg-early-morning-show-211830RadioPublic: https://radiopublic.com/dg-earlymorning-show-WoML4rBreaker: https://www.breaker.audio/dg-early-morning-showReason: https://reason.fm/podcast/dg-earlymorning-show--------------------------------------Check out my other stuff:Instagram: @itzdiamondgoatTwitter: @lildiamondgoatMain YT channel: youtube.com/diamondgoatTiktok: @lildiamondgoatSoundcloud: @Lil DiamondgoatSpotify: @Lil DiamondgoatMerch store: https://diamondgoat.creator-spring.com

In this episode of NAMSA's BiocompCHATibility Podcast, our hosts discuss early feasibility studies and the scope of biocompatibility necessary to get started. They highlight the importance of controlling device response in a small patient group and how this approach shapes biocompatibility considerations within the framework of risk management.“The control measure of just having a few patients is definitely used as a reason why, in part Biocompatibility doesn't need to be as extensive as it needs to be for a pivotal where you have hundreds of people and commercialization where you lose practically all control.” – Don Pohl“I want to make sure I'm choosing materials that I can support in my plan that I know have a general knowledge of safety.” – Sheri Krajewski“There's no specific guidance that tells you what you have to do in terms of testing and what you don't, but the concept is you're going to creep up on everything you'll do. You'll do some biocomp for early feasibility.” – Don PohlKey Discussion Points:Crafting a dynamic biological safety plan that evolves over timeEstablishing a robust evaluation strategy from the beginning to prevent missing important tests laterDesigning studies for high-risk cardiovascular implants and the importance of addressing biocompatibility and safety concerns

n this episode of NAMSA's BiocompCHATibility podcast, we welcome back Dr. Phil Smiraldo (Principal Toxicologist, NAMSA) for his third appearance as an honorary host. The discussion centers on the complexities of equivalency in biocompatibility, examining how equivalency can range from simple to complex and how a predicate device does not always equal equivalency.Listen in as we explore these topics with Dr. Smiraldo and gain insights into the intricate world of biocompatibility and the challenges faced when trying to establish equivalence between medical devices. “The world of equivalency runs the spectrum from incredibly simple to probably way too complex.” – Don Pohl“When we do these types of extractions on, we'll say prior devices and change to device, we're going to have variability within our experiments.” – Phil Smiraldo“You know whether you call it an equivalency assessment or change control assessment. Whatever you want to call it, I mean [10993] part one tells us if there's a change, you have to evaluate it.” – Don Pohl“I guess long story short, you could theoretically go through this whole exercise and end up with the two devices that are equivalent from a systemic toxicity perspective and that's it.” – Phil Smiraldo Key Discussion PointsImportance of confirming identical materials of construction, device categorization, and the IFU to ensure that the device remains equivalentThe detailed process required to establish proof of equivalenceThe critical role of adhering to standards in biocompatibility assessments

Oral health isn't just about having a nice smile; it's essential for our overall health, impacting different areas of our well-being. Similarly, when considering breast implants, it's crucial to recognize that their impact extends beyond cosmetic enhancement, potentially affecting overall health. Understanding the interplay between oral health and systemic health is vital for making informed decisions about medical interventions and ensuring holistic well-being. Embark on a journey through the world of holistic health and dental care with insights from Dr. Kelly Blodgett – a biologic dentist from Portland, Oregon. In today's episode, we discuss the intricate connection between oral and overall health, the impact of environmental factors, and the importance of informed decision-making for optimal well-being. Oral health and gut microbiome, with a focus on root canals and biofilms I deeply resonate with the principles Dr. Blodgett upholds, especially regarding oral health practices, particularly in patients with conditions like breast implant illness. Many patients are on a journey to rid their bodies of foreign substances that could potentially trigger inflammation, and biologic dentistry offers valuable insights and techniques to support them along this path. While it's widely acknowledged in both the dental and medical communities that gum disease is a significant issue, the attention it receives sometimes overshadows other potential sources of inflammation. Dr. Blodgett has observed the risk associated with root canals. The process of performing a root canal effectively creates a dead organ within the body by removing the tooth's blood supply. What's concerning is that the porous nature of the dentin surface allows microbes to infiltrate and thrive within these teeth, essentially turning them into chronic sources of toxicity. Over the years, Dr. Blodgett has seen remarkable improvements in patients' overall health following the removal of these dead teeth. We've integrated PCR testing of scar capsules into our practice which examines DNA fragments and this approach has yielded great results. Dr. Blodgett highlights the significance of understanding biofilm formation, particularly concerning teeth that no longer have a blood supply due to procedures like root canals. In an upcoming series based on 900 consecutive samples, we found that approximately 30 to 34% exhibited biofilm colonization, consisting of various microorganisms like bacteria, fungi, and mycobacteria. This microbial presence within the roots suggests a significant deviation from what's considered normal. Despite efforts to ensure quality testing by sending samples to a research-based laboratory specializing in PCR testing, there remain limitations in detecting microscopic processes through macroscopic examinations like CT scans, MRIs, or regular X-rays. Furthermore, Dr. Blodgett emphasizes the interconnectedness of oral health with overall well-being, noting how disruptions in the oral microbiome can contribute to various systemic problems. Issues such as poor digestion, irregular bowel movements, and compromised nutrient absorption can stem from an imbalanced microbiome, impacting the body's ability to heal and function optimally. Oral health and hygiene, including protein intake and its impact on teeth Maintaining normal digestive processes is crucial for overall health, as it impacts our gut microbiome and downstream health outcomes. The intricate relationship between oral health and the gut microbiome is fascinating insofar as oral health isn't just about aesthetics or chewing food; it's integral to proper digestion and nutrient absorption. For instance, missing teeth can hinder the chewing process, affecting how well we break down food and utilize nutrients. Managing the oral microbiome thus involves navigating various factors that can impact it. Common practices, like consuming acidic beverages or having multiple metal fillings, can disrupt the delicate balance of the mouth's ecology. It is therefore necessary to address these issues proactively rather than turning a blind eye. Addressing these issues involves considering the energetic and biological implications of dental treatments and materials used, as well as acknowledging potential sensitivities individuals may have to certain substances. By adopting a more holistic approach to oral care, we can better support both oral and systemic health. Oral health and its impact on overall health, including the importance of proper dental care and the risks of poor oral hygiene Many individuals are transitioning towards a more natural and holistic approach to well-being, especially those who have undergone procedures like breast augmentation or reconstruction and are now considering removing breast implants. In my practice, I emphasize the importance of dietary adjustments, including cutting out gluten, dairy, and processed sugars, to support overall health and well-being. These dietary changes are crucial as sugar, in particular, can be highly addictive and detrimental to health, impacting brain function and energy levels. That is why I always encourage clients to maintain a balanced fluid intake, neither overly acidic nor alkaline. During the preparation phase, I focus on increasing protein intake while cutting out unhealthy carbohydrates and fats. Digestive enzymes are also provided to aid in protein digestion, preventing gut discomfort and fermentation. Although I don't have a specific diet regimen, I advocate for a higher protein intake tailored to individual needs, typically ranging from one and a half to two and a half grams of protein per kilogram of body weight per day. This adjustment may require creative solutions for those struggling to meet their protein goals, such as incorporating amino acid supplements or protein-rich smoothies. In terms of oral health, dietary adjustments and fluid intake can have a significant impact. For example, high-protein diets may lead to buildup on teeth surfaces, as observed during teeth cleaning sessions. While protein intake remains essential for optimal functioning, managing its effects on oral health requires attention to hygiene and possibly adjustments in dental care routines. In surgeries, dentists often check for dental problems. If there's an issue, like infection or inflammation, the surgery might be postponed due to the risk of bacterial spread and potential complications like endocarditis. However, the sad truth is that despite longstanding awareness of these risks, they're not always taken seriously. This shows the need for greater emphasis on oral health in overall health management. Dental implants and cancer risk, with a focus on root canals and lymphatic drainage The standards set by organizations like the American Heart Association highlight the risks associated with microbial exposure in dental procedures. Surgeries involving heart valves, knee replacements, and hip joints pose risks because they share the same lymphatic drainage and blood supply pathways as the mouth. Despite this knowledge, the potential risks of microbial exposure from procedures like root canals are often overlooked. In fact, there are cases that show that addressing sources of toxicity, such as root canals, can lead to remarkable improvements in health, including relief from symptoms like cancer. Moreover, while titanium implants have been hailed as effective tooth replacements, they can lead to peri-implantitis, a condition characterized by inflammation and bone loss around the implant. This inflammation can have systemic effects, particularly in individuals already prone to inflammation, such as those with breast implants or joint issues. Despite the potential risks, there's often a lack of scrutiny within the dental profession regarding the broader systemic implications of these procedures. Health issues related to plastic water bottles, pesticides, heavy metals, and gluten sensitivity The environment we live in exposes us to various toxins like phthalates from plastic water bottles, glyphosate from pesticide-laden foods, and heavy metals from contaminated groundwater. Each person's response to these exposures is unique, influenced by factors like their genetic makeup and lifestyle choices. As a healthcare provider, listening to patients' personal anecdotes and understanding their history and exposures can provide valuable insights into their health challenges. Through attentive listening and assessment, healthcare professionals can better support patients in navigating their health journey. Detoxification, air quality, product safety, and optimizing oral health for overall wellness Understanding the impact of toxins on our health, especially considering individual genetics and vulnerabilities, is crucial. Lifestyle factors like poor diet, lack of sleep, and exposure to harmful substances can disrupt our body's detoxification processes, particularly affecting women due to their sensitive endocrine systems. Improving diet and lifestyle habits can have a profound impact on overall health, including oral and gut health, empowering individuals to initiate positive changes for themselves and their families. Thankfully, you can take proactive steps such as using resources like the Environmental Working Group website (https://www.ewg.org/) to make informed choices about the products they use, including dental care items. Addressing air quality is also crucial, especially in areas prone to mold and pollution, as poor air quality can have significant health implications. While filtered water is widely recognized as essential, filtered air is often overlooked but equally important for overall well-being. Understanding and improving air quality can have a profound impact on health, particularly for those sensitive to environmental factors like pollen and pollutants. Implementing air filtration systems in dental offices has become increasingly important, especially in light of concerns about virus and bacteria transmission. The COVID-19 pandemic prompted many dental offices to invest in quality air filters to significantly improve air quality and reduce exposure to harmful aerosols, leading to positive changes in workplace safety measures. Moreover, addressing environmental factors like water quality and avoiding potentially harmful products can contribute to overall health and well-being. Considering individuals' sensitivities and using tests like Biocompatibility to determine the least reactive dental products can help minimize adverse reactions and ensure better outcomes for patients. Take your oral health to the next level with Blodgett Dental Care: https://www.blodgettdentalcare.com/ About Dr. Rob's Solutions Podcast Austin's natural plastic surgeon Dr. Robert Whitfield brings you the true stories of actual patients, navigates through their surgical and non-surgical treatment options, then reveals their chosen path forward and the results they achieved. Dr. Rob is a board certified plastic surgeon and Austin's Natural Choice for plastic surgery, laser and energy treatments, and aesthetics. Visit Dr. Rob's Austin plastic surgery (https://www.drrobertwhitfield.com/) practice website or follow him on Instagram at @drrobertwhitfield (https://www.instagram.com/drrobertwhitfield/) Dr. Rob's Solutions is a production of TeamPodcast.com (https://www.teampodcast.com/)

Oral health isn't just about having a nice smile; it's essential for our overall health, impacting different areas of our well-being. Similarly, when considering breast implants, it's crucial to recognize that their impact extends beyond cosmetic enhancement, potentially affecting overall health. Understanding the interplay between oral health and systemic health is vital for making informed decisions about medical interventions and ensuring holistic well-being. Embark on a journey through the world of holistic health and dental care with insights from Dr. Kelly Blodgett – a biologic dentist from Portland, Oregon. In today's episode, we discuss the intricate connection between oral and overall health, the impact of environmental factors, and the importance of informed decision-making for optimal well-being. Oral health and gut microbiome, with a focus on root canals and biofilms I deeply resonate with the principles Dr. Blodgett upholds, especially regarding oral health practices, particularly in patients with conditions like breast implant illness. Many patients are on a journey to rid their bodies of foreign substances that could potentially trigger inflammation, and biologic dentistry offers valuable insights and techniques to support them along this path. While it's widely acknowledged in both the dental and medical communities that gum disease is a significant issue, the attention it receives sometimes overshadows other potential sources of inflammation. Dr. Blodgett has observed the risk associated with root canals. The process of performing a root canal effectively creates a dead organ within the body by removing the tooth's blood supply. What's concerning is that the porous nature of the dentin surface allows microbes to infiltrate and thrive within these teeth, essentially turning them into chronic sources of toxicity. Over the years, Dr. Blodgett has seen remarkable improvements in patients' overall health following the removal of these dead teeth. We've integrated PCR testing of scar capsules into our practice which examines DNA fragments and this approach has yielded great results. Dr. Blodgett highlights the significance of understanding biofilm formation, particularly concerning teeth that no longer have a blood supply due to procedures like root canals. In an upcoming series based on 900 consecutive samples, we found that approximately 30 to 34% exhibited biofilm colonization, consisting of various microorganisms like bacteria, fungi, and mycobacteria. This microbial presence within the roots suggests a significant deviation from what's considered normal. Despite efforts to ensure quality testing by sending samples to a research-based laboratory specializing in PCR testing, there remain limitations in detecting microscopic processes through macroscopic examinations like CT scans, MRIs, or regular X-rays. Furthermore, Dr. Blodgett emphasizes the interconnectedness of oral health with overall well-being, noting how disruptions in the oral microbiome can contribute to various systemic problems. Issues such as poor digestion, irregular bowel movements, and compromised nutrient absorption can stem from an imbalanced microbiome, impacting the body's ability to heal and function optimally. Oral health and hygiene, including protein intake and its impact on teeth Maintaining normal digestive processes is crucial for overall health, as it impacts our gut microbiome and downstream health outcomes. The intricate relationship between oral health and the gut microbiome is fascinating insofar as oral health isn't just about aesthetics or chewing food; it's integral to proper digestion and nutrient absorption. For instance, missing teeth can hinder the chewing process, affecting how well we break down food and utilize nutrients. Managing the oral microbiome thus involves navigating various factors that can impact it. Common practices, like consuming acidic beverages or having multiple metal fillings, can disrupt the delicate balance of the mouth's ecology. It is therefore necessary to address these issues proactively rather than turning a blind eye. Addressing these issues involves considering the energetic and biological implications of dental treatments and materials used, as well as acknowledging potential sensitivities individuals may have to certain substances. By adopting a more holistic approach to oral care, we can better support both oral and systemic health. Oral health and its impact on overall health, including the importance of proper dental care and the risks of poor oral hygiene Many individuals are transitioning towards a more natural and holistic approach to well-being, especially those who have undergone procedures like breast augmentation or reconstruction and are now considering removing breast implants. In my practice, I emphasize the importance of dietary adjustments, including cutting out gluten, dairy, and processed sugars, to support overall health and well-being. These dietary changes are crucial as sugar, in particular, can be highly addictive and detrimental to health, impacting brain function and energy levels. That is why I always encourage clients to maintain a balanced fluid intake, neither overly acidic nor alkaline. During the preparation phase, I focus on increasing protein intake while cutting out unhealthy carbohydrates and fats. Digestive enzymes are also provided to aid in protein digestion, preventing gut discomfort and fermentation. Although I don't have a specific diet regimen, I advocate for a higher protein intake tailored to individual needs, typically ranging from one and a half to two and a half grams of protein per kilogram of body weight per day. This adjustment may require creative solutions for those struggling to meet their protein goals, such as incorporating amino acid supplements or protein-rich smoothies. In terms of oral health, dietary adjustments and fluid intake can have a significant impact. For example, high-protein diets may lead to buildup on teeth surfaces, as observed during teeth cleaning sessions. While protein intake remains essential for optimal functioning, managing its effects on oral health requires attention to hygiene and possibly adjustments in dental care routines. In surgeries, dentists often check for dental problems. If there's an issue, like infection or inflammation, the surgery might be postponed due to the risk of bacterial spread and potential complications like endocarditis. However, the sad truth is that despite longstanding awareness of these risks, they're not always taken seriously. This shows the need for greater emphasis on oral health in overall health management. Dental implants and cancer risk, with a focus on root canals and lymphatic drainage The standards set by organizations like the American Heart Association highlight the risks associated with microbial exposure in dental procedures. Surgeries involving heart valves, knee replacements, and hip joints pose risks because they share the same lymphatic drainage and blood supply pathways as the mouth. Despite this knowledge, the potential risks of microbial exposure from procedures like root canals are often overlooked. In fact, there are cases that show that addressing sources of toxicity, such as root canals, can lead to remarkable improvements in health, including relief from symptoms like cancer. Moreover, while titanium implants have been hailed as effective tooth replacements, they can lead to peri-implantitis, a condition characterized by inflammation and bone loss around the implant. This inflammation can have systemic effects, particularly in individuals already prone to inflammation, such as those with breast implants or joint issues. Despite the potential risks, there's often a lack of scrutiny within the dental profession regarding the broader systemic implications of these procedures. Health issues related to plastic water bottles, pesticides, heavy metals, and gluten sensitivity The environment we live in exposes us to various toxins like phthalates from plastic water bottles, glyphosate from pesticide-laden foods, and heavy metals from contaminated groundwater. Each person's response to these exposures is unique, influenced by factors like their genetic makeup and lifestyle choices. As a healthcare provider, listening to patients' personal anecdotes and understanding their history and exposures can provide valuable insights into their health challenges. Through attentive listening and assessment, healthcare professionals can better support patients in navigating their health journey. Detoxification, air quality, product safety, and optimizing oral health for overall wellness Understanding the impact of toxins on our health, especially considering individual genetics and vulnerabilities, is crucial. Lifestyle factors like poor diet, lack of sleep, and exposure to harmful substances can disrupt our body's detoxification processes, particularly affecting women due to their sensitive endocrine systems. Improving diet and lifestyle habits can have a profound impact on overall health, including oral and gut health, empowering individuals to initiate positive changes for themselves and their families. Thankfully, you can take proactive steps such as using resources like the Environmental Working Group website (https://www.ewg.org/) to make informed choices about the products they use, including dental care items. Addressing air quality is also crucial, especially in areas prone to mold and pollution, as poor air quality can have significant health implications. While filtered water is widely recognized as essential, filtered air is often overlooked but equally important for overall well-being. Understanding and improving air quality can have a profound impact on health, particularly for those sensitive to environmental factors like pollen and pollutants. Implementing air filtration systems in dental offices has become increasingly important, especially in light of concerns about virus and bacteria transmission. The COVID-19 pandemic prompted many dental offices to invest in quality air filters to significantly improve air quality and reduce exposure to harmful aerosols, leading to positive changes in workplace safety measures. Moreover, addressing environmental factors like water quality and avoiding potentially harmful products can contribute to overall health and well-being. Considering individuals' sensitivities and using tests like Biocompatibility to determine the least reactive dental products can help minimize adverse reactions and ensure better outcomes for patients. Take your oral health to the next level with Blodgett Dental Care: https://www.blodgettdentalcare.com/ Links and Resources Dr. Robert Whitfield's Website (https://drrobssolutions.com/) Follow Dr. Rob on Instagram https://www.instagram.com/drrobertwhitfield/ For more information on Virtual and In Person Consultations, we always answer our messenger personally: https://www.drrobertwhitfield.com/contact/ About Dr. Rob Dr. Robert Whitfield (https://www.drrobertwhitfield.com/dr-whitfield-2/) In 2012, Dr. Whitfield came to Austin and became renowned for his breast surgery expertise. He set up his own practice in 2017. Here, he offers the men and women of Austin a full range of cosmetic procedures, both surgical and non-surgical, addressing the full array of breast, body and face. Born and bred in Las Vegas, Austin plastic surgeon Dr. Whitfield received his medical degree from the University of Las Vegas School of Medicine. This was followed by six years of surgical training, as well as his plastic surgery residency at Indiana University Medical Center. He returned to Nevada for a one year microsurgery fellowship before settling down to practice and teach at the Medical College of Wisconsin for seven years. Board-certified by the American Board of Plastic Surgery, Dr. Whitfield's approach to medicine has really been shaped by both his upbringing and his education. As a child of the “wild west,” he was born with an adventurous spirit. One of the reasons that he was drawn to plastic surgery is the constant innovation. In the field of plastic surgery, with innovative techniques and technologies developed each year, there are simply issues for which a solution has yet to be invented. Dr. Whitfield tempers his intrepid attitude with Midwestern pragmatism. It makes for a pretty winning combination.

If you have or suspect you have candida & SIFO, let's break down what it is, why it happens, and 4 simple strategies for relief.  If you have any additional questions you would like answered in the future, let me know in the comments!   Watch/Read Next… What is the Strongest Candida Killer? https://drruscio.com/strongest-candida-killer/  Do You Need a Candida Test? https://drruscio.com/candida-overgrowth-test/ SIFO with Dr. Satish Rao: https://drruscio.com/sifo-small-intestinal-fungal-overgrowth/  Make it Yours—Daily Gut Health Routine to Fit Your Lifestyle: https://drruscio.com/daily-gut-health-routine/  How to Heal Your Gut Naturally: https://drruscio.com/how-to-heal-your-gut-naturally/    Timestamps 00:00 Intro  01:04 What IS candida?  03:38 The causes of candida  07:01 Candida testing  12:08 The role of oral health  14:21 How to gauge candida levels 17:05 How to balance the WHOLE microbiome 22:15 Supplements AS effective as meds 27:55 Herbal antifungals    Featured Studies  Candidiasis: https://pubmed.ncbi.nlm.nih.gov/32809459/  Candida albicans- The Virulence Factors and Clinical Manifestations of Infection: https://pubmed.ncbi.nlm.nih.gov/33499276/  Healthy Diet and Lifestyle Improve the Gut Microbiota and Help Combat Fungal Infection: https://pubmed.ncbi.nlm.nih.gov/37375058/   Intestinal candidiasis and antibiotic usage in children: case study of Nsukka, South Eastern Nigeria: https://pubmed.ncbi.nlm.nih.gov/29937890/  Investigating Colonization of the Healthy Adult Gastrointestinal Tract by Fungi: https://pubmed.ncbi.nlm.nih.gov/29600282/  Fungal feelings in the irritable bowel syndrome: the intestinal mycobiome and abdominal pain: https://pubmed.ncbi.nlm.nih.gov/36723172/  Dysmotility and proton pump inhibitor use are independent risk factors for small intestinal bacterial and/or fungal overgrowth: https://pubmed.ncbi.nlm.nih.gov/23574267/  Beyond Just Bacteria: Functional Biomes in the Gut Ecosystem Including Virome, Mycobiome, Archaeome and Helminths: https://pubmed.ncbi.nlm.nih.gov/32231141/  What is the Healthy Gut Microbiota Composition? A Changing Ecosystem across Age, Environment, Diet, and Diseases: https://pubmed.ncbi.nlm.nih.gov/30634578/  Commensal Fungi in Health and Disease: https://pubmed.ncbi.nlm.nih.gov/28799901/  Healthy Diet and Lifestyle Improve the Gut Microbiota and Help Combat Fungal Infection - PMC: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10302699/  Archaea and fungi of the human gut microbiome: correlations with diet and bacterial residents: https://pubmed.ncbi.nlm.nih.gov/23799070/  The dietary modification and treatment of intestinal Candida overgrowth - a pilot study: https://pubmed.ncbi.nlm.nih.gov/30166063/  Manipulation of Host Diet To Reduce Gastrointestinal Colonization by the Opportunistic Pathogen Candida albicans: https://pubmed.ncbi.nlm.nih.gov/27303684/  Comparison of the therapeutic effects of Garcin(®) and fluconazole on Candida vaginitis: https://pubmed.ncbi.nlm.nih.gov/26512149/  Biocompatibility and Effectiveness of a Novel, Organic Olive Oil-Based Denture Adhesive: A Multicenter Randomized and Placebo-Controlled Clinical Trial: https://pubmed.ncbi.nlm.nih.gov/33805975/  Vitamin D-supplemented yogurt drink reduces Candida infections in a paediatric intensive care unit: a randomised, placebo-controlled clinical trial: https://pubmed.ncbi.nlm.nih.gov/30773722/   Investigating Colonization of the Healthy Adult Gastrointestinal Tract by Fungi - PMC: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5874442/   Comparing the Effect of Probiotic and Fluconazole on Treatment and Recurrence of Vulvovaginal Candidiasis: a Triple-Blinded Randomized Controlled Trial: https://pubmed.ncbi.nlm.nih.gov/36198994/   Effect of Probiotics on Oral Candidiasis: A Systematic Review and Meta-Analysis: https://pubmed.ncbi.nlm.nih.gov/31615039/   Probiotics Prevent Candida Colonization and Invasive Fungal Sepsis in Preterm Neonates: A Systematic Review and Meta-Analysis of Randomized Controlled Trials: https://pubmed.ncbi.nlm.nih.gov/27793494/   Prophylactic Saccharomyces boulardii versus nystatin for the prevention of fungal colonization and invasive fungal infection in premature infants: https://pubmed.ncbi.nlm.nih.gov/23703468/     Get the Latest Updates Facebook - https://www.facebook.com/DrRusciodc Instagram - https://www.instagram.com/drrusciodc/ Pinterest - https://www.pinterest.com/drmichaelrusciodc    DISCLAIMER: The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified healthcare provider before starting any new treatment or discontinuing an existing treatment. Music featured in this video: "Modern Technology" by Andrew G, https://audiojungle.net/user/andrew_g  *Full transcript available on YouTube by clicking the “Show transcript” button on the bottom right of the video.

Marina Daineko, a biocompatibility expert with a background in analytical chemistry, shares her journey from a research assistant in physical chemical problems to a prominent figure in the medtech industry. Marina discusses her passion for understanding the regulatory compliance and quality management systems in medical devices, reflecting on her curiosity and desire to make a difference in people's lives. She also shares her commitment to increasing women's representation in the medtech field. Guest links: https://www.linkedin.com/in/marinadaineko | https://www.intrinsicmedicalgroup.com Charity supported: ASPCA Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 023 - Marina Daineko [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:52] Hello, and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I'm excited to introduce you to my guest today, Marina Daineko. Marina, a certified biocompatibility subject matter expert with an MSc in analytical chemistry, shines as a dynamic figure at the intersection of medtech and chemistry. Her knack for seamlessly bridging biocompatibility, regulatory compliance and materials science, sets her apart. Marina's captivating presentations at conferences, including the prestigious Women in Tech Global Conference 2023, underscores her multifaceted expertise in the medtech industry. [00:01:31] Welcome. Thank you so much for joining us. I'm so excited to have you here today. [00:01:36] Marina Daineko: Hello, Lindsey. Nice to meet you. Thank you very much. [00:01:40] Lindsey Dinneen: Yes, absolutely. I was wondering if we could start off by you just sharing a little bit about your background and yourself and how you got into the medtech industry. [00:01:51] Marina Daineko: Oh, yeah, absolutely. Actually, it's very interesting story because I have started with medical device industry, not from the very beginning. But since I was young, I have always had a keen interest in learning more about the properties and different forms of matters and understanding how this undergo changes. So all in all, I fell in love with chemistry while I was in high school, and knew that I need to proceed with chemistry in my adult life. So anything that can be touched, tasted, smelled, seen, or felt is made of chemicals. And I was inspired by this fact and yeah, so I decided to connect my life with it. [00:02:36] And it's interesting because I started my career as a research assistant in the Research Institute for Physical Chemical Problems. And here I had a really scientific background because I published several articles, put my hands into patent work, and so on and so forth. And everything related to non resist photocatalytic lithography and nanoelectronics. So far away from medtech industry. And yeah, but it was interesting for me. And it was sometime after that it was time of self discovery through challenges, because I wanted to do something in my career that is challenging, interesting, and makes a difference in people's lives on a daily basis. [00:03:23] And actually around this time, I found out that my ancestor, Vladimir Galalyev, was a researcher in medicine and published academic papers dedicated to rheumatism and the morphology of allergy. So, I found it interesting and I decided that I might delve into this area, into this domain. So all in all, I started look for opportunities and found out RNC position. And that's why I joined MedTech industry as R&D and my background in chemistry and material of science helped me a lot here. And I'm a curious person, so when I was working as R&D, I also was trying to understand, "Okay, what are the sources of different requirements?" What are these come from, what are all these regulations that some people are talking from time to time. [00:04:20] And as a result, yeah, that was really interesting for me. Okay, I need to understand the source. I need to understand the matter, what I'm doing, why I'm doing. So, and as a result, I started to look into regulatory compliance area and overall, like, quality management system, just understand how the things work and to understand medical devices from different areas, right? Because it can have very different requirements depending on what aspect you're looking from, right? [00:04:51] So I was really fascinated and thankfully I had the chance to, to join biocompatibility and biological evaluation team as R&D also understands the requirements with chemical background in chemistry. So I started to look into biological evaluation to, because it's so interesting for me, look here, it's mixture of science, also medical device, and additionally some investigation, some topics that are not discovered or something like this. So it's really nice. And also next step I decided, okay, I'm pretty aware like what are things with medical devices that contain hardware for instance, but how make this medical device life. Because it's really interesting and fascinating to see how their lives can be changed. [00:05:45] So that's bring me to software in the medical devices. So software and firmware is something that could help to make medical devices live so they can be used in some analysis, predictions, and so on and so forth. And that's why I'm here in the medical device industry, really enjoying what I'm doing and understanding the medical device from different perspectives. [00:06:10] Lindsey Dinneen: Yeah, that's wonderful. Thank you so much for sharing your background too. It's so fun for me to hear about how you go from so many different, yeah, because you're so multi talented, and you're so interested in so many things, and I love hearing that. I love hearing about your background in chemistry and then you went into R&D and now you're doing software and firmware. Oh my goodness, you are a lifelong learner! [00:06:38] Marina Daineko: Yeah, I believe it's very important because we are living in book of world. It means that, there are a lot of changes around us. And additionally, for me, it's really interesting. I'm really fascinated to see is a medical device from different sites. Okay, we have compliance. Compliance means like this requirements, right? We have R&D and product quality and biological relations and those requirements may be applied, and when touching one topic, it's very interesting to see what is beyond this topic. For instance, as I said, okay, R&D requirements, design input, design verification activities, and so on, according to, for instance, ISO 13485 or CFR part 820. But what about regulatory, right? What about FERS? [00:07:27] Moreover, it's also, yeah, one thing that I'm proud right now is that this year I took a very bold choice to become a student one more time and I selected a program that focused on the medical sterilization engineer. So I believe it helps me to understand medical device even deeper because biocompatibility and sterilization are things that lay near each other. So just to deep my knowledge in the sterilization and disinfection areas, I picked this program. So I'm a student again. It's a very nice feeling. [00:08:09] Lindsey Dinneen: Oh good, yeah. I love how you said that, it's a nice feeling. [00:08:15] Marina Daineko: Like back to school, yeah! [00:08:17] Lindsey Dinneen: Yes, that is ,incredible though and it is so Interesting to hear how you just keep developing your skills, and like you said, you're a curious person, so you're going continue to explore different ways and help the industry move forward. So, good for you. [00:08:35] Marina Daineko: New choices for industry, [00:08:36] Lindsey Dinneen: Nice. Nice. Okay. So, I know that you also are an advocate for women in medtech, and I would love if you would share a little bit more about that and your involvement. How did all that get started, and what are you optimistic about with that? [00:08:56] Marina Daineko: Oh yeah, it's great questions. Thank you very much for asking it. So it has started actually recently when I was invited to speak at Women in Tech conference. So I was really excited here because in my experience, I-- all right, some time ago, long, long time ago, I don't remember even how many years it was-- I tried to start a business as a woman and unfortunately, I have got quite a lot of pushbacks with said words, like for instance, "okay, you need to sit down at home and growing up children and I don't know, cooking," and for me it was like a question, "okay, I can do it truly, but I have like other perspective and other ambitions and willing motivation to grow like a professional, like an expert." So for me it's very important to show an example for other people, women said, "okay, we can, surely we can grow up children. Surely we can take care of some other people and cooking and cleaning, like this man." [00:10:09] So it's very important to show an example that I can do it. So everyone can do it. Everyone has own voice and this voice shall be heard. It's very important. So it started quite innocent for me, just invitation to, to talk at the conference, but I was so proud of it. And I shared this news with my colleagues, with my family, friends like with everyone, I believe, and trying to support this. [00:10:39] Moreover, recently I has been nominated for Women in Tech nomination. So, and I'm so excited of it because my presentation, I was talking about Internet of Medical Things actually, and compliance and risk aspects within IoMT. So, my, my talk as a speaker and I was congratulated with this nomination, so I'm so proud to, to show again other people that, "okay, look it start, it has started really innocently, but where I am now." [00:11:13] I'm nominated and I am growing awareness regarding women in tech and asking for collaboration here as a women to join this network because I could see a lot of opportunities with it like to support each other, to help each other to grow together, because when we are sharing our expertise, when we are given advices, when we are providing areas for improvements, it is really also very important, actually, our points of growth here. So I believe it's very valuable network and really could see a lot of improvements while taking part in this Women Tech Network. [00:11:54] Lindsey Dinneen: That's incredible. And first of all, congratulations on that nomination! [00:11:59] Marina Daineko: Thank you. Thank you so much. [00:12:01] Lindsey Dinneen: That's incredible. Yeah, I'm so excited to see where that leads, but in general, I [00:12:06] Marina Daineko: Yeah. [00:12:08] Lindsey Dinneen: Yeah! And you're like, oh my goodness, "yes, me too!" Ha Yeah, but I just I love the fact that, it started off with an ask of you do this talk, and then you just said, "okay, and I'm diving into this too." So, [00:12:25] Marina Daineko: It's exactly how it works with me. [00:12:26] Lindsey Dinneen: Okay. Excellent. Yeah. And, I know from being connected with you on LinkedIn that you are very passionate about helping to spread knowledge about the industry. Yeah, and so you do this Mondays, you do like a coffee chat or coffee talk. Yeah. Can you tell us a little bit more about that? [00:12:50] Marina Daineko: Absolutely. So it's again interesting story because sometime ago, actually I have started to be pretty active on my LinkedIn, like just around the year or so. And how I, why I decided to be active and why, how it's actually started. It started because I felt like I'm so full of expertise, knowledge, advice that I can't just hold them with myself so I need to somehow to share them and I found LinkedIn platform very useful and comfortable for such knowledge sharing because here there is a community of different experts and that's why we can share opinions, advices, comments, because it's also valuable to see from some things from our perspective, right? [00:13:43] And on Mondays, I'm doing like Monday news. And I remember when I'm using actually my own picture. I took this picture when I had a coffee and croissant, like dreaming, "okay, what would I like to read on Mondays?" And for me, it was kind of a digest of important things. And I usually connect in this important available things around biological evaluation, because I could see quite a lot of information regarding compliance, quality management system, risk management clinical evaluation, like really ocean of news and updates and knowledge sharing regarding clinical evaluation. [00:14:24] But for some reasons, I saw that biological evaluation is kind of underestimated, meaning that-- and it's quite, it's not too easy to find some valuable information or clarify something or, to make it transparent and traceable why we need to go like this direction or this direction, and what are updates in the industry and so on so forth. And I know that quite a lot of people are too shy to ask directly or they simply don't know whom to ask, right? Because if you are known as a subject matter expert in this domain, nobody would ask you even if you are right. [00:15:03] So, and it helped me to understand like, okay, maybe I could put myself in this niche and provide some updates like I'm doing here on Mondays, like taking one topic and provide small basic, maybe basic, maybe not too basic things, around this topic. Like for instance, biological evolution, but inside of biological evolution, we have a lot of things to talk. And to be honest, I can talk about a biocompatibility like all days and nights. It can be unstoppable. So, yeah. [00:15:42] Lindsey Dinneen: Okay, so you have lots of things in the works and you're a student still. What is coming up for you? What is next that you're particularly excited about either personally or professionally or whatever you want to talk about. [00:15:55] Excellent [00:15:56] about [00:15:56] marina_1_10-18-2023_190318: My God, I swear a lot of things, to be honest. Yeah. First of all, maybe from professional side, I'm really excited to take part in the MedTech Summit. Flying to the United States, and I'm really excited because there would be a lot of professionals and subject matter experts within the summit like from biological evaluation, as well as regulatory affairs. So I'm very interested to make like connection in real life, not only like online, looking at people's heads and that's it. [00:16:34] Lindsey Dinneen: Right? [00:16:37] Marina Daineko: So, I'm really excited of it. Also I will have panel session about post market surveillance. And it's very interesting, actually, format because it would be different experts here at this panel, like from regulatory, clinical, risk management. And I will represent biological evaluation aspect. So, and we would be talking about post market surveillance for medical devices. It's also hot topic and I'm excited because in such format is it, that would be my first time in such format with other experts, but I find it really valuable because this cross functional team usually, it's like kind of brainstorming, negotiation, discussion. So I expect like a vivid discussion around this topic and again I believe that would be very interesting insights here during this panel. Yeah. [00:17:34] Lindsey Dinneen: Yeah. Yeah. And, speaking to that, when you are involved in these these panel discussions or conversations or things where you might, where like you said, you're going to be surrounded by experts and you have your area of expertise too and whatnot and you're sort of all collaborating, is there ever a moment where, does it ever feel overwhelming when you're just " oh, I don't know enough about this topic?" I'm just curious because I know sometimes we have those moments as humans. We go into this situation that's not 100 percent our realm, and I'm just curious how you handle those moments of " how can I contribute to this conversation?" [00:18:13] Marina Daineko: Yeah, that's a great question because I wouldn't be honest if I say that I don't have such moments. Surely I have and as I'm quite active as a speaker in different conferences. So surely I have such moments in my life. And yeah, so, how I deal, I'm trying to be logical, first of all, and structured. Actually, I'm a super structured person. I have folder and folder, all the reminders and so on. Organized and structured. But, yeah, so I'm trying to think in this way, "Okay, here is the question. How can I decompose it for the parts that I can understand, right?", And I can provide some feedback, insight or advice, for instance, right? Because usually a person who is asking a question, this person usually has some background or circumstances or conditions why this question is asked. So I'm trying to decompose this question if it's still unclear. So I'm trying, I'm asking to ask maybe in a different way. It gives me additional time to think actually, so well, right? [00:19:19] So, and in that for, I would say for 100% cases with this decomposition or, and for instance, asking to reward the question, I can answer it because it gives me time to think the decomposition can gives me the base, " okay, we are talking about XYZ or ABC or what we are talking about, right? What area from what perspective?" So all the things help me to answer, but usually, yeah decomposition and additional time to think helped me each time. [00:19:57] Lindsey Dinneen: Yeah, and thank you for your honesty, because I really love listening to other people's strategies, because I think we all have those moments sometimes, right? [00:20:04] Marina Daineko: Absolutely. It's very nice because I also can understand, okay, what are my weakness? What my, what are my areas for improvement? Maybe I need to dive deeper into this topic. But, I am, I consider myself brave enough to say, I don't know if I really don't know something, right? Not to, not to make a not proper conclusions, for instance, or advices and so on, so forth, because it's very important to, to say such things because we are talking about medical devices. Medical devices are used when people are in need some help. It might be even the question of life and death so it's very important to say if I don't know so I'm saying I don't know, please ask this I need additional time to investigate. So I need to so I need this additional time, right? [00:20:56] And also what is very important for me as again as a woman and as immigrant, right? Not to be shy, but to talk, to speak up because yeah, I can be, I am an expert. And I need to show my expertise to others because others, other people can, for instance, they just simply maybe not aware that I'm expert, right? So it's very important to speak up and to be brave here. [00:21:26] Lindsey Dinneen: Yes, a hundred percent. And I kept thinking about that when you've been telling us about your life and your trajectory and how curious you are. And I was going to say that bravery is such a strong theme. I, it really is though, because it is hard sometimes to be willing to speak up and say, "I don't know, or I let me go back and research or whatever." And so I really, I think that's really powerful what you said, and I appreciate your candor there. And I'm, I am also curious myself, so if, let's say that you are in a sort of mentorship position. What kind of advice would you give somebody, maybe especially a woman or, somebody who is coming from a different background who may not have the same access basically, how would you advise that person to participate and to keep moving forward with their own career, even if they're feeling a little uncertain or they don't fit in. [00:22:30] Marina Daineko: Oh, yeah. No, I love this question. Thank you for asking it. So, I believe that we are living in such a world where hard skills shall be complemented with soft skills. And as far as I could see, listening is very important. Listening and communicating properly. And listening, I believe that listening to others is a part of communication. So, regarding listening, it's very important to listen,: like kind of correctly what I mean on this is for instance, not multitasking when someone is listening to another person, right? Because sometimes we are doing something and listening not attentively. And we, for instance, can mix up topics or don't understand something or just don't miss some part of, conversation. And that's why it's very important to, to listen attentively, really deep really diving into the topic and understanding what is going to be, like, what we are talking about, what is the topic, what is the ask. Maybe something is hidden between rows, so it's very important. [00:23:44] Sometimes we are listening with a goal in mind. What it means? We have we are talking to each other, right? But I have my goal in, into my mind, so it doesn't matter actually what you are talking about. So. I have something and that's it. I don't care. So it doesn't work. It doesn't work actually. So especially for leadership, but not only for leadership, it's just for, for real life. It doesn't work. We need to listen and trying to understand what another person is trying to say here. [00:24:20] And one more, maybe things that I noticed is judging. So when something, when someone is saying something, so we are judging. We are like, okay, there is just black and white and that's it. But fortunately, no, we have different colors, so like rainbow colors, there is no black and white, so we don't, we should, we shall not judge, we need to listen attentively, accurately, and trying to get rid of maybe some negativity when talking to a person, so it's very important because collaborating with different people may be challenging, especially in these cross functional teams because I could see more and more that we are working in remote world. [00:25:08] So I'm from Poland, you're from the United States. Someone is from the United Kingdom, someone from Australia and it's really amazing and I love it. But people are from different cultures. People have different, I don't know, mood, time zones, different things in their private life. So it's very important to switch off this as, as much as possible, this emotional thing and don't judge, just take the information as it is. And actually it helps me also a lot when I'm doing internal audits. So as it's written, I could see, and I could just, yeah, ask for some evidence as it's written not judging here. [00:25:50] And maybe one more topic here I would like to raise, it's about preparing your response. So when, for instance, my colleague is talking to me and I just codes the first sentence, for instance, right? And I'm answering to this sentence, not to whole speech or whole things that this person is trying to say, but to this sentence . Please don't prepare your response and improve your listening skills. I believe that this listening skills, first of all, when we are collaborating with other colleagues from other, I don't know, departments, for instance, like product quality or clinical affairs, regulatory affairs, R&D manufacturing, so it's very good, marketing, some other. So it's very important to listen and to listen to the messages because there are a lot of valuable information. It shall be filtered accordingly and taken into account for, taken for consideration. [00:26:51] And when we have like good listening skills, we can proceed with improving our communication because I believe that communication is just powerful tools that can resolve any, simply any issue, challenge, whatever, if we can communicate effectively so it helps. It helps a lot in professional life, in not only professional , so it's very important to work on this. [00:27:17] But coming back to your question, I believe that any person can entry medical device industry because there are a lot of directions here. This directions depends on people background. So here we need like mechanical engineers to be able to prepare drawings and actually work on new product development or modifications of existing medical devices, for instance, right? Someone with a chemistry, biology background needed for like specific things like biological evaluation, clinical evaluation, right? [00:27:49] But even people without technical background, someone who is like a good communicator is very nice. It's very valuable person in the project because such person can help with communication between different departments, because someone needs to orchestrate all this work for medical device. So don't be afraid, listen carefully, and improve your communication skill. And I believe, yeah, it would help in any industry, including medical devices. [00:28:21] Lindsey Dinneen: Yes, that's great advice and thank you for sharing that. I think you're right that in many aspects, so one of them, [00:28:29] Marina Daineko: Thank [00:28:30] Lindsey Dinneen: I just want to clarify, agree with you, one thing that stood out to me is, you said that it, It is definitely possible for people to come into the medical device industry. And I think you're absolutely right. There are lots of avenues within the industry. So if your background is in engineering, there's plenty of places for you to go, but if your background is in marketing and sales, I mean, people have to know your device exists in purchase it. So all of the roles are are useful. So I think you're absolutely right in finding the area where you fit in. But the industry is really friendly, is what I have, yeah. [00:29:12] Marina Daineko: Absolutely. Because if I can, yeah, add here, for instance, for marketing and sales, so, I love these people because they help me a lot. Why? Because I am doing, for instance, biological evaluation, I need, this is my documentation, I need to explain other people from notified bodies who, for instance,. Can audit this documentation how this medical device works. And what happened here? Look, I need these people from notified bodies or like from like auditors, right? They can have really different background. They can have background in clinical or they may not have this background. They may just have, I don't know, absolutely different background, right? They are not familiar with this specific medical device. [00:30:01] So, and within my biological evolution, I need to explain how this medical device works. And it's known fact that a lot of people can consume the information with their eyes. So it's visual. So it means that the information shall be visualized, and visualization is the best tool to explain some things to people. That's why I love marketing, people from marketing and sales, because they can prepare these great pictures of medical device, how it works, for instance, on YouTube, like video or whatever, right? As well as, yeah, to make it understandable for everyone. It's simple, not with all these tons of words. But usually it, it shall be described as well, right? But visualization as well. So, that's why, yeah, I triggered so much when you mentioned marketing and sales, because yeah, it's really important to explain complex things in pictures. [00:31:02] Lindsey Dinneen: Yes. Indeed. Yes. And I'm glad to have an advocate for that. [00:31:12] Marina Daineko: Absolutely. Yeah. Yeah. [00:31:13] Lindsey Dinneen: Yeah, absolutely. Pivoting the conversation just a little for fun. Imagine you were to be offered a chance to teach a masterclass on any subject that you want to. You would be paid a million dollars to do so. It can be about your industry, but it doesn't have to be. What would you choose to teach and why? [00:31:35] Marina Daineko: As I said, I can talk days and nights about biological evaluation. So maybe it would be the simplest answer because it really, it really works for me. I mean, like I can talk about biocompatibility a lot and I am more than happy to share some insight with people, especially taking into account that this buzz and noise regarding biological evaluation recently, and I could see a lot of people that are coming in this aspect, this domain, I mean, in biological evaluation in medical devices, so I would be more than happy even be paid properly for this. [00:32:18] Lindsey Dinneen: There you go. [00:32:20] Marina Daineko: Yeah. [00:32:22] Lindsey Dinneen: You could put the million dollars to, your research or something fun, so. [00:32:27] Marina Daineko: Yeah. No, absolutely. When I was younger, I had actually a dream to organize a kind of, research center and to have some equipment, to have some databases, and so on for scientists who can, for instance, like scientists, startups, and so on so forth who can actually try, say, ideas on this on this research center. So if you, for instance, I don't know, invented something, you can go to my research center and I, we can first of all, test it and also provide like scientific background if required to help with patents and so on and so forth. So I believe this million dollars can be used for this goal. [00:33:12] Lindsey Dinneen: Ooh, I like it. Okay. Excellent. All right. And how do you wish to be remembered after you leave this world? [00:33:24] Marina Daineko: This is important question and I'm thinking from time to time exactly on it. So, it's very personal for me because it's also a funny story. When I was a student at the university, I was, I have been providing kind of mentorship for people who would like to study chemistry. So, and usually I was working with, mentorship, blaming the fire for chemistry. So showing that chemistry is not just something boring, boring science, but also very interesting and it can be kind of fun. So, I had a case when one boy he needed he needed improve his knowledge for chemistry just for his marks because he intended to, to get in British College. And, we were having the studies with him. I was explaining things and providing real life examples where and how chemistry can be utilized and improved. And in the end, this boy decided to utilize chemistry in his life, so he switched from math as well as physics to chemistry and connected his life with chemistry. [00:34:40] And for me, it was like, "Oh my God, it seems like I changed someone's life." And it was so, so inspiring for me that I decided for myself that I would like to proceed with it, that I like how I can make this connection to show people the beauty of different things, like for instance chemistry to this boy. And yeah, I believe that I'm pretty successful in such things, so I would say that I would like to be remembered as a person who can connect people with beautiful and inspiring things, changing lives in this matter. [00:35:26] Lindsey Dinneen: Ooh, that is a beautiful goal. I love it. That just gave me chills. [00:35:33] you [00:35:34] Marina Daineko: Yeah, no, I feel the same, actually, because for me, this boy, it was like a changing moment for me. Yeah, it's very powerful. Even this even this memory is very powerful for me. [00:35:47] Lindsey Dinneen: Yes. Thank you for sharing that story. It's a fantastic story, and I love that because it's so, that just speaks to you and your willingness to, to help somebody understand something that doesn't come naturally or maybe easily to them. And what a difference you made in that person's life, so, yes, I think that's incredible and a beautiful life goal of yours. [00:36:11] Marina Daineko: Thank Thank you, Lindsey. Oh yeah. To explain like complex things into simple, understandable steps is my favorite entertainment, I would say [00:36:21] Lindsey Dinneen: Ah, okay, I love it, alright. What is one thing that makes you smile every time you see or think about it? [00:36:32] Marina Daineko: Oh, I believe it's my dog. I have pitbull, but she reminds me a cat, mostly, because, yeah, no, really, because, for instance, when I have a door opened to join other room, to go into other room, for instance, but when I close the door she needs to come back immediately. And it makes me smile because it's behavior of a cat and also yeah she's sleeping and she is snoring from time to time and when I have a meeting for instance with my colleagues So I am asked all the time "Marina, please don't sleep." Yeah. So, yeah it's funny and I adore her. I am working with her, actually, I like, I love walking like 10 kilometers or so. She's not happy with this distance, but she has just simply no choice with it. Yeah. So, yeah, no, believe useful for her heart, so that's my, yeah. [00:37:35] Lindsey Dinneen: Mutually beneficial for both of you. [00:37:37] Marina Daineko: Yeah. [00:37:38] Lindsey Dinneen: Yeah. Very good. Oh my goodness. That's fantastic. Yeah. This has been so much fun. Thank you so very much for joining us today. I'm just so thrilled to have you and you're so inspirational. So thank you for doing what you're doing and how you're continuing to learn and evolve with the industry, but evolve your own skills too. Yeah. And we're, [00:38:05] Marina Daineko: Thank you. [00:38:06] Lindsey Dinneen: Of course. And we're so honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thank you for choosing that organization to ,support and we just wish you continued success as you work to change lives for a better world. [00:38:30] Marina Daineko: Thank you. Thank you so much, Lindsey. It was a pleasure. I really enjoyed our conversation, a lot of, love and insight. So thank you very much for invitation and yeah I'm really happy to meet you. [00:38:45] Lindsey Dinneen: You too. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:38:58] [00:38:59] Ben Trombold: The leading difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

On the latest installment of the BiocompCHATibility podcastis episode, our hosts are joined by Dr. Phil Smiraldo for his third feature3-peat episode on the podcast.The conversation throughout this episode focuses and we discuss on the new recently published FDA biocompatibility guidance document —issued onn September 7, 2023.“My favorite nuance is that annex A has slightly been updated because now the X's and O's are almost all gone.” – Don Pohl“Of these materials, you touch them every day, and your clothes are made out of them... Why would we need to do biocompatibility testing as a device? At a high level, that is what [(Attachment G)] says.” – Don Pohl “There are a few caveats, such as devices made for neonates… they are going to want to see the data. And similar type wording for pregnant woman.” – Phil Smiraldo“We are not saying it's never possible, but you're going to have to really convince us if you only look at Part 1 and not our guidance” – Sheri Krajewski-Bibins“One thing that I do like about this FDA document is it uses the same language from the ISO 10993 series.” – Phil SmiraldoDiscussion points include:Verbiage updates to legally market devices and the fineprint.The Addition of Appendix G and how it can be utilized.A general overview of other changes by the FDA from their previous document.

(3:00) - 3D printing with bacteria-loaded ink produces bone-like compositesThis episode was brought to you by Mouser, our favorite place to get electronics parts for any project, whether it be a hobby at home or a prototype for work. Click HERE to learn about how additive manufacturing is being leveraged in the medical industry from bone replacement to dental guides!

This is audio from RQM+ Live! #64, recorded 16 February 2023. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website. Over the past several years the expectations for testing of medical devices per the ISO 10993 standards has significantly changed and continues to change at a rapid pace. Furthermore, different regulatory bodies have different expectations when evaluating this data. Failure to understand these expectations and an inappropriate choice of testing labs can result in product delays and repeat testing. The expert panel will: Describe how chemical characterization, toxicological risk assessment and biological testing work together to evaluate a device Explain how to ensure method sensitivity, maximize quantitative accuracy and identification confidence Highlight which validation experiments are expected for chemical characterization Discuss the major points of departure between European notified bodies and US FDA Explain which certifications are necessary for laboratories Show how controls used, and when are they necessary in biological testing Evaluate how revisions to ISO 10993-17 may impact toxicological risk assessment Panelists: Joel M. Cohen, Sc.D., DABT – Principal, Gradient Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation, RQM+ Kevin Rowland – Director of R&D, RQM+ Taryn Meade – Director of Biological Evaluation Consulting, RQM+ Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation, RQM+ (moderator) --- Send in a voice message: https://anchor.fm/deviceadvice/message

What are submission deficiencies due to biocompatibility and how do medical device companies overcome them in trials, studies, and regulatory post-market surveillance?In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Parker, Associate Department Head of In-Vivo Biocompatibility at Toxikon Corporation on how to overcome and prevent those submission deficiencies.Some of the highlights of this episode include:When a manufacturer puts their package together for a submission to the FDA, if it is not approved, then the FDA issues a deficiency or request for additional information due to a question or issue with some part of the submission.If a deficiency is issued, the FDA allows the manufacturer to handle it in one of two ways—either correct it through a memo/risk assessment or retest.It is better to be proactive rather than reactive when addressing a deficiency. A little bit of time upfront with the FDA will save a lot of time on the backend.Competition: When most medical devices are being developed, there is intent. Either it's a completely new idea or existing product that another manufacturer offers that you want to build or improve upon.Prop 65 and new European regulations strive to keep out carcinogens, mutagens, reproductive toxins, and other compounds that at certain thresholds may be of concern and should not be included in devices or labeling is required.When it comes to quality, ISO standards and FDA regulations are in the best interest of the patient but may be a costly burden for the manufacturers. It takes units of a medical device to complete evaluations for biocompatibility testing.It takes days, months, or requires extensions for some companies to do remedial work and meet expectations when responding to a deficiency.Implement quality from the beginning with a quality management system (QMS) to understand expectations of standards, practices, and regulations. Memorable quotes from Chris Parker:“In a fair number of instances, there are cases where the FDA issues what we call a deficiency. It's otherwise known as a request for additional information. But generally, what it is, is they have a question or an issue with some part of the submission.”“Be proactive, not reactive because then a little bit of time upfront will save you a lot of time on the backend.”“A lot of devices, when they are being developed, you're doing it with intent in mind. Either it's a completely novel, new idea or you saw a product and you said there's a greater market than a particular other manufacturer offers, we want to jump into it or we want to improve it.”“Let's try to keep out anything of potential concern that we can at any concentration.”Links:Chris Parker on LinkedInLabcorpEtienne Nichols on LinkedInFDA - Overview of Device RegulationFDA - Select Updates for Biocompatibility of Certain Devices in Contact with Intact SkinISO 10993-1:2018 - Biological evaluation of medical devicesProposition 65European Union Medical Device Regulation (EU MDR)Medical Design and Manufacturing Event (MD&M West)GG AcademyMedTech NationGreenlight Guru

On this episode of the podcast, I was joined by Hsinjin Yang of Pioneer Scientific Solutions. Hsinjin and I discuss: - Materials for Biomedical Applications - Mechanical Properties, Physical Properties, Biocompatibility, E&L and Sterilization - Commercialization Considerations - 4 Major Factors for the appropriate selection of materials Dr. Hsinjin Yang PhD is a Materials Engineer with more than 30 years of experience in the areas of Polymers/Materials Science and Engineering for infrastructure in renewable energy systems, biomedical devices/packaging, medication delivery system, optical ophthalmic lens, imaging materials and polymer blends. He has 25 patents (21 issued & 4 filed), and more than 50 publications in Journals or Book Chapter or Conference Proceedings.

Tammy Sparacino, CCP discusses the blood air interface, common to cardiopulmonary bypass, and how this initiates the inflammatory cascade. Tammy also discusses biocompatible surfaces and how these attenuate the inflammatory cascade.

This is the audio from RQM+ Live! #52, recorded 7 April, 2022. During our previous show on this topic we were flooded with questions from viewers (which we love!) and couldn't answer them all, so we're back for a sequel. Generating evidence of biocompatibility continues to be a significant challenge to regulatory submission success and product-to-market timelines. And global requirements and interpretations continue to evolve, further increasing the challenge. Rollover questions we'll kick the discussion off with: Have you had any unique or unexpected feedback from notified bodies or FDA? Have you seen misinterpretations by the regulators? What is the difference between Physical and/or chemical information vs chemical characterization? For reusable devices, has there been any requests for "biocompatibility over the lifetime" per ISO 10993-1:2018, and if so, how is this typically handled? Is it necessary to have a toxicologist expert interpreting chemical characterization data? What do you do if you have a large number of unknowns in chemical characterization? How do you use exemptions for intact skin devices made of common materials (U.S.)? The panel of subject matter experts, including former FDA CDRH and BSI leaders: Jaishankar (Jai) Kutty, Ph.D. - VP, Intelligence & Innovation Kevin Go, RAC - Project Engineer (former FDA CDRH Lead Reviewer) Lucie Dalet, Ph.D. - Senior Regulatory Specialist Questions: 2:28 -- Have you had any unique or unexpected feedback from notified bodies or the FDA? Have you seen any misinterpretations? 9:26 -- Does the FDA influx of new staff factor into the micromanaged questioning and more rigorous approach? 13:20 -- Are we seeing any delays because of laboratories being backed up? 16:50 -- Are there trends from the FDA on adopting biocompatibility testing? Is there an uptake for special 510(k) submissions? 18:02 -- Has anyone had FDA pushback on LCMS ionization mode justification ACPI vs. ESI? (more context added throughout question) 23:29 -- Has anyone had any experience with questions on biocompatibility over the lifetime? If the device is reusable, should the cleaning agents be incorporated in the testing as well? 26:57 -- What testing do you recommend to confirm that a suspected cleaning operation doesn't leave the part with significant contamination; e.g., cleaning off mold release or stainless-steel solder flux? 30:10 -- How are we advising our clients with legacy devices and their approach? 32:44 -- How do you use exemptions for intact skin devices made of common materials (U.S.)? 36:58 -- Differences between physical and/or chemical information vs. chemical characterization... what are your thoughts? 39:40 -- What do you do if you have a large number of unknowns in chemical characterization? 41:20 -- What about devices that are compatible with chemical characterization? 43:30 -- Do the manufacturers need to provide any evidence for their CrCo device whether the cancer and death cases reported in their PMS are not related to Cobalt content in the device? --- Send in a voice message: https://anchor.fm/deviceadvice/message

In this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel, Matt a board-certified toxicologist with a Ph.D. in chemistry and is Nelson Laboratory's Chemistry and Materials Scientist and Helin is Nelson Labs Senior Biocompatibility Expert with a Ph.D. in cell biology.Listen in as Matt and Helin help educate our listers about the world of pre-clinical testing/biocompatibility for medical devices by taking a deep dive into cytotoxicity testing of medical devices in this part of the Intro into Biocompatblity podcast series.About RCARegulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.About Nelson LabsEvery year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology and analytical chemistry testing industry, offering more than 800 laboratory tests and employing more than 500 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it is our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.Companies choose Nelson Labs for our:Thought leaders and approachable experts. We give you direct access to industry authorities who understand your business and add value every step of the way.Customer-centric culture. We take the time to understand your vision. Your goals become our goals.Real-time project management tools and a dedicated client portal. We provide proactive information, keeping you informed and in control.Metric-driven testing processes. We're our own toughest customer, holding ourselves to goals exceeding 99% for things that matter most to you, like quality, turnaround time, and testing accuracy.Global compliance expertise and support. We act as a trusted advisor, helping you navigate the ever-changing compliance landscape.See how we can help you mitigate risk, be first to market, and succeed with your customers. 

In this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel, Matt a board-certified toxicologist with a Ph.D. in chemistry and is Nelson Laboratory's Chemistry and Materials Scientist and Helin is Nelson Labs Senior Biocompatibility Expert with a Ph.D. in cell biology.Listen in as Matt and Helin help educate our listers about the world of pre-clinical testing/biocompatibility for medical devices. We cover the basic background of pre-clinical testing, explore the new things happening in the field, go over some best practices for testing, and then end with some advice on picking a testing lab for yourself.About RCARegulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience. 

This is the audio from RQM+ Live! #45, originally recorded 16 December, 2021. Generating evidence of biocompatibility continues to be a significant challenge to regulatory submission success and product-to-market timelines. And global requirements and interpretations continue to evolve, further increasing the challenge. In this show, we will discuss the changes to standards in recent years, what's on the horizon for 2022, and answers to common questions we receive like the following: Is the biocompatibility approach different for US and EU? When should you consider a chemical characterization approach? How do you use exemptions for intact skin devices made of common materials (US)? What's the best process for managing changes to material or manufacturing processes? What can you change and still claim equivalence? What new developments have there been in 2021? Here's the esteemed panel of subject matter experts, including former FDA CDRH and BSI leaders: Jaishankar (Jai) Kutty, Ph.D. VP, Intelligence & Innovation Nancy Morrison, RAC - Executive Director, Regulatory & Quality Consulting Services Jonathan Gimbel, PhD - Executive Director, Technical Leadership, Clinical & Post-Market Practice Kevin Go - Project Engineer (former FDA CDRH Lead Reviewer) - Next RQM+ Live! show: RQM+ Live! #46, 13 January - Year-end Review and 2022 Outlook on FDA Submissions Stay informed: See all expert content Subscribe to our blog Follow us on LinkedIn - About RQM+ RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com. --- Send in a voice message: https://anchor.fm/deviceadvice/message

The Elemental Philosophorum: Titanium, Memory "Metal", Biocompatibility, Energy Harvests & Resonance.

This podcast episode is really important as this answers some of the questions that a lot of my customers are asking. So I hope this will help you to understand why this is important to perform a Biological Evaluation or Biocompatibility for your finished product. The post How to perform a Biological Evaluation for your Medical Device? appeared first on Medical Device made Easy Podcast.

Over the last year, the BiocompCHATibility Podcast hosts have been compiling questions asked by our listeners and training series attendees. In this episode, we will answer your frequently asked questions about all things biocompatibility—and no, we did not answer why Don is funnier than Sheri (it is definitely a growth opportunity for her). Highlights include: The use of clinical data in the biological evaluation Completing chemistry testing before in vitro/in vivo studies Gathering historic data -and how much is useful to the evaluation U.S. FDA and DBT (dose base threshold) values The truth about “whole lifecycle” evaluation “I can certainly do a preliminary risk assessment and not have any extractables testing because part of my plan might be to go do extractables testing; but that doesn’t mean I always need it.” – Don Pohl “If you have clinical data and you are doing a preliminary risk assessment to evaluate the safety of this device, it is general information and cannot be ignored. But, if you are going to use the data to offset the need for a test, it better speak to the endpoint very specifically.” – Don Pohl “For manufacturing, I make sure to understand what was there and what wasn’t there. Mapping the process out is important for the reader of the assessment to understand I have performed the evaluation of the manufacturing and any impact it has on biological safety.” – Don Pohl

In this episode, our hosts are joined by APS’s Senior Director of Biocompatibility Services, Dr. Yan Chen, to discuss NAMSA’s acquisition of APS and the importance of preclinical studies in the biological evaluation of medical devices. This podcast discussion revolves around the many synergies of the combined companies, as well as a technical discussion regarding preclinical studies, preclinical study biocompatibility endpoints, and of course, an energetic game of ‘2 Truths and a Lie’ that will surely bring you a laugh. “We have expanded the possibilities of people who can join us now.”-Sheri Krajewski “We are very excited. We firmly believe that both companies share the same goals to provide high-quality, comprehensive services for medical device development.” – Dr. Chen “Companies are beginning to think about biocompatibility when they should early-on with studies like these. These [preclinical] studies can be so powerful in so many ways.” – Don Pohl “The local tissue response is the most commonly used (biocomp endpoint) in the preclinical study. Sometimes you want a clinically relevant implant site. That is something to keep in mind to combine (preclinical and biocomp) studies.” – Dr. Chen Discussion points include: The importance of preclinical testing to the biological evaluation Early-stage preclinical studies vs. GLP studies and the value they bring to medical device regulatory submissions The challenges of combining preclinical and biocomp studies

In this episode, our guests are joined by Syntactx’s Dr. Valerie Merkle, Associate Director – Regulatory Strategy, to discuss NAMSA’s recent acquisition of Syntactx. During this one-hour installment, Dr. Merkle discusses her deep-rooted experience at the FDA and the importance of proper biological safety planning to achieve biomechanical efficiency and successful clinical trial execution. Examples will be provided regarding how and when biocompatibility programs go wrong, which often result in derailment of development efforts. How can manufacturers create biocompatibility programs that are observed favorably by the FDA? Learn helpful tips and strategies to help ensure a successful FDA submission. “We really wanted to mirror what we were doing at the FDA.” – Valerie Merkle “You just never know what is going to come in next. It keeps you on your toes for sure.” – Don Pohl “People think biocomp is just a checklist, but there are a lot of rabbit holes you can go down—a lot of ways you can stray off the path unnecessarily. Definitely not a checklist item.” – Valerie Merkle “Make good decisions early-on to not derail yourself later.” – Sheri Krajewski-Bibins “A lot of companies don’t want to provide their thought process. They spend years and years developing and making decisions, FDA only sees what is in front of them and if the background is not there, we see lots of questions.” – Valerie Merkle Discussion points include: Syntactx company overview and strengths they bring to NAMSA Material selection and its importance in avoiding derailment of biocompatibility projects FDA experiences with manufacturers overlooking material testing FDA biocompatibility guidance and its role in regulatory submissions

In this episode, our hosts are joined by Allison C. Komiyama, Ph.D., R.A.C., Owner and Consultant at AcKnowledge Regulatory Strategies and former U.S. FDA reviewer, to discuss the U.S. FDA’s latest draft guidance, “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.”  The FDA has determined the biocompatibility risk of various polymers and fabrics to be low based upon a safe history of use in medical devices for this categorization. Our hosts dive into the list of materials as well as the nuances of this guidance that will ideally help manufacturers with these types of devices receive market access with fewer questions.   “There might be some unnecessary testing going on in some cases.” –Don Pohl “The long history of safe use. U.S. FDA uses a lot of resources to not only review the tests themselves, but they mention they spend resources on review of rationale and justifications; and I think that may be harder than reviewing test reports.” – Allison Komiyama “It was very exciting when we saw this guidance document. We all felt like this was a long time coming.” – Allison Komiyama “Class VI testing might become useful again.” – Sheri Krajewski-Bibins “People are going to be googling Type 4 Sensitivity to figure out what that is because its sitting on a label.” – Don Pohl “I commend the biocomp group on this document.” – Allison Komiyama “I was thinking about a device I’m reviewing right now. I look back at that device and it has stainless steel and aluminum, and if I look at all those polymers, I have co-polymers as well. If I look at this guidance now, I would be left wondering if I can apply everything here or am I going to have to do cyto, sensitization and irritation because I have metals and some co-polymers that aren’t necessarily defined.” – Don Pohl “Guidance is U.S. FDA’s current thinking, and even if it is a draft, we’ve had many reviewers say “there’s a new draft guidance, look at that”.” –Allison Komiyama Discussion points include:  Complete overview of the guidance and implementation Inclusions and exclusions for materials and devices Submission guidelines when applying this guidance Information needed to submit for these types of devices immediately Precautionary labeling instructions that may be necessary

Should your medical device company address biocompatibility? The short answer is, yes. Every single medical device should conduct some level of biocompatibility testing. What's important is that you understand to what extent. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about biocompatibility of devices, the applicable FDA and ISO guidelines companies need to follow, and the possible ramifications if you don't. Some of the highlights of the show include: Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin: FDA Draft Guidance is new, but doesn't cover any new content. FDA's intent is to clarify the types of biocompatibility information in submissions for certain devices made from common polymers and fabrics that come in contact with intact skin. What is biocompatibility testing? If you don't know, that's why regulation and guidance is necessary. Nobody knows everything, recognize what you don't. ISO 10993 Evaluation and Testing: Review guidance, educate yourself, and engage experts because objective evidence is needed to corroborate the case for biocompatibility. FDA's Recommendations for Biocompatibility: List device materials with direct/indirect skin contact and statement comparing/confirming safe use of those materials. Provide history and clinical study reports of adverse effects/events of skin contact materials, such as redness, swelling, irritation, allergic responses. Documenting sponsorship determining where biocompatibility risk and testing is not necessary, such as purchasing controls. Using labeling to mitigate risk of possible skin reactions. Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: FDA Final Guidance raises special considerations for thermomechanical behavior and processing sensitivity of nitinol when compared to conventional metals.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s guidances on biocompatibility submissions and nitinol-containing devices. Although the two are separate guidance documents, we combine them into a single discussion. Specifically, we address a number of questions, including:What is the biocompatibility guidance in regard to?Does this help simplify the pathway to market for commonly used materials that have a proven record?The fact that we’re talking about “intact skin surface,” this wouldn’t apply to any type of wound care products, correct?With the nintinol-containing devices guidance, what’s the purpose behind that?Is this guidance primarily being put out due to the potential for an allergic reaction to nickel or is it more about the unique physical characteristics of Nitinol?What are the primary takeaways from these guidances device makers should keep in mind?There are also a number of references made. Following are links for more information on those items.Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin (Draft, Oct, 2020)Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" [Finalized Sept, 2020]Final Guidance: Technical Considerations for NonClinical Assessment of Medical Devices Containing Nitinol (Oct 15, 2020; draft issued April 2019)Mike on Medtech: FDA's Material Evaluation (April 2, 2019)Mike on Medtech: Biomaterials, Biocompatibility, and Bioabsorbable (July 25, 2017) Listen to this episode and see what you think of these two guidance documents and whether they could affect an upcoming product you are producing. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode. Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

In this episode, our hosts are joined by Nicole Soucy, PhD, DABT from Boston Scientific to discuss qualifications of expert assessors and other personnel qualified to make biological evaluation decisions for medical devices. Documents including ISO 10993-1, Medical Device Regulation (MDR) documentation submissions and BSI best practice guidelines recommend having a qualified individual make decisions for the biocompatibility of medical devices.While many testing organizations claim to perform this work, what does “qualified” really mean and how do companies determine this qualification?In this episode, our experts discuss hiring and training processes utilized to identify and grow qualified individuals within their organizations.“What are the qualifications that a person needs to have to evaluate the biocompatibility of a device? We get questioned about it all the time.” –Don Pohl“Anytime you have a position open…you’re looking for that needle in a haystack to find someone who is appropriately qualified and has a good, strong background.” -Nicole Soucy“You are not going to go out and find someone who has a Bachelor’s or Master’s degree—or even a PhD—in medical device biocompatibility; those people don’t exist. There is definitely an on-the-job training component to growing and developing this skill set.” -Nicole Soucy“A really critical partner in all of this is your analytical chemist. They need to be integrated into you team. You need to have strong chemistry support all the way through your project.” -Nicole SoucyDiscussion points include:How this role is the “famed unicorn” of medical device developmentHow on-the-job training is a critical component to successful assessorsHow long until an assessor is able to work independently on a plan and assessmentChallenges with regulators utilizing an assessment properlyWhat someone looks for when choosing a qualified individual to perform this work*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

In this episode our hosts are joined by 2 esteemed colleagues from Abbott: Deanna Porter, Kent Grove to discuss the US FDA pre-sub meeting process as it pertains to the biocompatibility of Medical devices.The group will review the current procedure for a pre-sub meeting and how this opportunity to obtain FDA feedback prior to an intended submission can be very useful, especially for programs containing chemical characterization or other complex testing protocols.It’s a great opportunity to receive feedback and responses to specific questions, although not guaranteeing approval, the guests show today how using this process saves them valuable time in their biological evaluation.“When you see 3 responses in a week with 15-17 questions about biocomp, it makes you wonder if there’s a way to make this process more effective.” – Don Pohl“We focus the presubs and take advantage of this meeting with the FDA” – Kent Grove“We like to focus the meeting on a specific need, so that we can really zero in on the responses and the guidance that we specifically need.” -Deanna Porter“Little things can make a difference in profile.” -Kent Grove“The key to a successful presub is knowing what you know and what you don’t know so you put the right detail into the presub.” -Don Pohl “Have very pointed questions, not presenting a lot of ambiguity, making sure you understand what you want to get out of them, what answer you are seeking, so that it speaks specifically to the input that you are requiring them to provide.” -Deanna PorterDiscussion points include:How is a presub meeting useful in evaluating the biological safety of medical devicesWhat types of questions are useful to include in a presub What can you expect the FDA to provide to you in a presubHow can you insure the data you are getting from extractables/leachables program will be most usefulWhat can you do to insure the proper FDA personnel is present to answer the questions you have in a Presub meeting

In this episode our hosts are joined by Jeremy Koehler, Director of R&D for Prescient Surgical. Prescient Surgical is a small medical device company in the San Francisco area, with a biocompatibility story to tell.Their first product submitted to the FDA, although not a high risk device, encountered delays directly related to some biocompatibility testing and the program. As a young start-up this can be very time consuming and most of all expensive.“As a small company, speed is everything and time is a precious commodity.” Jeremy Koehler“Externally communicating, limited contact. What more is there to talk about? What gives? As it played out it got a little bit more interesting.” Don Pohl“The challenge came when we didn’t really have a good scientific justification for what we’d done and why we did it and why it was appropriate and sufficient.” – Jeremy Koehler“Kind of the moral here is to have a solid scientific plan to help you down the road.” Sheri Krajewski-Bibins“It’s important to mention that not every change triggers new testing.” Jeremy Koehler“There’s plenty of projects that I’m involved in where I tell people; You don’t have to do testing, you have to address biocomp but that doesn’t always mean testing.” Don PohlDiscussion points include:When to perform a biological evaluation strategy in the product development processMaterial selection and biocompatibilityHow a “passing” test does not mean there won’t be reviewer questionsHow the scope of biocompatibility reaches into the development cycle and planning for biocomp can alleviate challenges down the roadIt’s never too early to start planning for the biological safety of the device

In this special release episode, our hosts are joined by Dr. Phil Smiraldo, Toxicologist at NAMSA.During this episode the team discusses the current pandemic situation of Covid 19 and the production of ventilators and respirators to help treat and prevent spread of this virus. With companies like Dyson, Ford, GMC and others discussing the design and/or manufacture of ventilators to meet the growing need of infected patients, how do we insure biological safety on a very short term?Hosts will discuss some guidance put in place by the UK and USFDA alike that address these needs and offer some guidance and solutions.This is a great example of the evaluation of risk/benefit and how using risk as your guide for biological safety is so critical. These documents go through risk mitigation through various means, which may address evaluation endpoints outlined in ISO 18562, the document that guides the evaluation of air pathway devices.“Respirator is a protection piece of equipment… technically in the US may not even be a medical device – although a surgical mask is a medical device,” – Don Pohl“This (ventilator) is an actual instrument that is helping you breathe - whether it’s provided a positive pressure situation or its doing your inhaling and exhaling for you. So these are very different than respirators.” -Dr. Phil Smiraldo“Biocompatibility associated with all these different guidance (documents) as they pertain to ventilators, masks, respirators - it’s certainly interesting to at least ponder where biocompatibility falls in the grand scheme of things.” – Don Pohl“The lungs are quite efficient at absorbing chemicals and putting those chemicals into systemic circulation.” – Dr. Phil Smiraldo“It’s a risk evaluation. Is the short term solution more critical than any long term risks of exposure?” - Sheri Krajewski-BibinsDiscussion points include:Difference between respirators and ventilators and their evaluation processOverview of the US and UK guidance documents for ventilatorsSelecting materials to help control the chemical possibly releasedParticles – and how to produce in a “relatively clean” environmentThe use of these short term ventilators for acute, life-saving care until a CE Mark device could be used

Our hosts are joined this week by Stephanie Taylor, Staff Scientist - Toxicology and Biocompatibility at DePuy Synthes Companies. During this episode the team discusses the reprocessing of reusable devices and the challenges of the ever- changing landscape of the biological evaluation of such devices.There is activity requested both by the USDA and the EU that greatly impacts the timelines and costs of evaluating these devices for biological safety, so the team shares some strategies and practices used by manufacturers today to meet high regulatory expectations.“The end goal is a defensible position.” -Stephanie Taylor“The magic number 6? I don’t know if that’s justifiable.” - Don Pohl“What’s your biocomp at the end of life – you have to be able to figure that out.” - Stephanie Taylor“Biocomp is interesting, challenging and a little bit magical at times.” – Stephanie TaylorDiscussion points include: Why the great concern with such devices?The differentiation between an end of life evaluation and what might be expected currently by the USFDA.The great cost and time involved in such evaluations and burdens on manufacturers.

As the ISO Technical Committee 194 prepares to meet later this year, we look at the planned changes to the standards, the rising prominence of chemical characterisation and the efforts to eliminate animal testing.Join James Morrison and Jean Boudaud to learn what’s hot in ISO 10993 biocompatibility evaluation.

Our hosts are joined this week by David Parente, Director of Global Sterilization at and Biological Safety at Ecolab.  During this episode the team discusses Dave’s chapters in the new book, Biocompatibility and Performance of Medical Devices.  Dave has a long history with the biological evaluation process, including founding NAMSA’s first biological safety consulting team, NAMSA Advisory Services.  For many years Dave has been teaching and writing about the importance of a plan.  Additionally, Dave has years of experience as a manufacturer facing the challenges of meeting biological evaluation expectations from regulators.“It all speaks to the importance of a plan.. plan, evaluate, plan, evaluate.  Things change and you have to do this continually” – Don Pohl “Every device does not fit on this table.”  Sheri Krajewski-Bibins “If your truly understand the risks your device introduces udrin it’s intended use– that’s an active means in evaluating biocompatibility ” – Dave Parente “As a segue to the 2018 version of 10993-1 and it’s greater emphasis on one of the aspects of biocompatibility – manufacturing effects on the safety of a device” – Don Pohl “Originally everyone just said this is a checklist – and credit to TC 194 they have slowly over the past 10 years or so transformed biocomp to what it should be – it’s risk assessment.  There are several degrees of risk..…  If I have to mitigate this risk, then what’s my plan for mitigation?”  Dave Parente Connect with Dave here https://www.linkedin.com/in/davidmparente/

Our hosts are joined this week by Dr. Jean Pierre Boutrand, VP of North American Laboratory Services at NAMSA.  During this episode the team discusses the new book, Biocompatibility and Performance of Medical Devices.  Jean Pierre is the Editor of this collection of experiences by esteemed authors in the biocompatibility and medical device profession.  This is the second edition of the book, originally published in 2012 and the focus of the new edition is how to accelerate a product to market and ways to plan for evaluation. From the book cover “Biocompatibility and Performance of Medical Devices, Second Edition, brings an understanding of evaluation strategies for ensuring that medical devices and biomaterials are safe and effective and will perform s expected in the biological environments.  This second edition is updated and expanded to include the latest developments in nonclinical research to support rapid market introduction of innovative medical devices and biomaterials.”Discussion points include:Pertinent changes since the 2012 edition that effect today’s marketHow experts and topics were chosen for this edition of the bookHow listeners can win a free copy of the new bookThe inspiration and motivation for this type of book in the industryEnter to win a book at www2.namsa.com/freebook

Biocompatibility can be challenging and frustrating when developing a medical device. Why do you have to spend time and money to do the same testing, if the materials used in your device have already been tested, approved, and put in medical devices on the market? Biocompatibility impacts the majority of medical devices. Today's guest is Josh Crist, a biocompatibility expert who used to work for the FDA and is now with Biologics Consulting and he and Jon discuss the nuances of biocompatibility. Some of the highlights of the show include: ● Best practices for biocompatibility include using the ISO 10993 test matrix for evaluating tissue, duration, and other factors. ● A common misconception about the test matrix is how the FDA determines and considers cumulative contact. ● Are all tests absolutely necessary? Are there other ways to reduce testing requirements? Consider chemical characterization and risk assessments. ● Josh describes challenges he experienced as both a biocompatibility consultant and FDA reviewer. ● What the FDA expects with chemical characterization: Master file, testing on final finished device, and more. ● Start with FDA's biocompatibility guidance documents, interact early on with FDA during pre-submission process, and conduct quantitative and qualitative tests. ● “I promise…” days are gone. Other options for 510(k) to avoid getting additional information (AI) letter or not substantially equivalent (NSE) decision. ● Most common mistake made by companies when it comes to biocompatibility is not testing.

On this week, The Sci-Files, Chelsie and Danny interview Cort Thompson.Cort is a Ph.D. student at MSU's Biomedical Engineering department where he is studying the ways in which implanted neural interfaces affect the brain. His research focuses on understanding how specific components of current electrode array technologies affect biocompatibility at the molecular and cellular level. His experiments explore the ways in which device design impacts the cellular populations in the brain to better inform on future device design in the field of neural engineering.Neural interfaces are a rapidly advancing technology that offers a vast array of potential therapeutic uses. Neural interfaces and their ability to record from and stimulate the brain are being researched all over the world by both academia and private industry in an attempt to better understand neuroscience and to treat injury and disease. Many initiatives such as the Braingate project have successfully connected the human motor cortex with assistive robotic devices to improve the quality of life for individuals suffering from debilitating neurological conditions.  A considerable amount of progress has been made toward the improvement of neural interfaces in recent years through the advancement of electrode technology and signal decoding. There is still progress to be made however on the path to creating seamlessly integrated neural devices. As it turns out, the brain reacts poorly to foreign objects. Many implanted devices suffer from chronic tissue inflammation for as long as they remain embedded in the brain. Implantation of invasive neural devices damages blood vessels, neurons, and other brain cells which results in inflammation and scarring around the device. This chronic inflammation is generally assumed to play a role in the functional decline of implanted electronics. Biocompatibility is an area of neural interface research that is becoming more important as neural interfaces become more sophisticated and as clinical implementation becomes more common.If you're interested in talking about your MSU research on the radio or nominating a student, please email Chelsie and Danny at scifiles@impact89fm.org. Check The Sci-Files out on Twitter @SciFiles89FM and on Facebook!

Biocompatibility can be challenging and frustrating when developing a medical device. Why do you have to spend time and money to do the same testing, if the materials used in your device have already been tested, approved, and put in medical devices on the market? Biocompatibility impacts the majority of medical devices. Today’s guest is Josh Crist, a biocompatibility expert who used to work for the FDA and is now with Biologics Consulting and he and Jon discuss the nuances of biocompatibility. Some of the highlights of the show include: ● Best practices for biocompatibility include using the ISO 10993 test matrix for evaluating tissue, duration, and other factors. ● A common misconception about the test matrix is how the FDA determines and considers cumulative contact. ● Are all tests absolutely necessary? Are there other ways to reduce testing requirements? Consider chemical characterization and risk assessments. ● Josh describes challenges he experienced as both a biocompatibility consultant and FDA reviewer. ● What the FDA expects with chemical characterization: Master file, testing on final finished device, and more. ● Start with FDA’s biocompatibility guidance documents, interact early on with FDA during pre-submission process, and conduct quantitative and qualitative tests. ● “I promise…” days are gone. Other options for 510(k) to avoid getting additional information (AI) letter or not substantially equivalent (NSE) decision. ● Most common mistake made by companies when it comes to biocompatibility is not testing.

A frank conversation between internationally recognised experts on four big ticket items in medical device evaluation, including:- Changing Standards and changing regulator expectations.- Physical & Chemical information.- What to do about the whole “Risk Management Process” idea.- Skills required, and here/how to find them.Presented by: Arthur Brandwood & James Morrison

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the differences between materials and biomaterials, biocompatibility, biofriendly, biostable, and bioabsorbable. Specifically, the following questions are addressed: What’s the difference between a material and a biomaterial?What’s the difference between a biocompatible material versus a biofriendly material?How is a biostable material different from a bioabsorable/biodegradable materials?Do bioabsorables pose additional challenges?Do the regulatory rules for biomaterials differ from the ones that are currently followed for more traditional materials?What’s your response to companies who would rather not attempt to introduce a new material (or biomaterial) to the regulatory approval process?Check out the guidance mentioned in this podcast—ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

Academic Qualifications: Graduated Dentist by the Faculty of Dental Medicine of the University of Oporto (FMDUP) with a final grade of 17 out of 20 (1996-2002)   Post graduation in Implantology (Bränemark Institute in Gothenburg and Maxilla-Facial Surgery Ward at Västerås Hospital, Sweden) (2002)   Specialisation Course in Implantology at the Faculty of Dental Medicine, University of Oporto (FMDUP) with a final grade of Good (2003-2006)   Master’s Degree (MSc) in Implantology by the Faculty of Dental Medicine (FMDUP) (2006-2007) and investigation thesis under the title “Experimental study of a new biomembrane (MES) for guided bone regeneration” with a final unanimous grade of Very Good (top grade)   Undergoing PhD programme (Implantology) in the Faculty of Dental Medicine of the University of Oporto (FMDUP 2013-2016) Dental License   Professional license No. 4013 of the Portuguese Dental Medicine Association   Merit Awards Rectory of the University of Oporto- Best finalist student award   Belmiro de Azevedo Foundation 98/99 and 99/00   Machado Capelas/ Labmed 98/99, 99/00, 00/01 and 01/02   Barbosa and Almeida Enterprise (SONAE Group) in every secondary and university grades   Engº António de Almeida Foundation 2002   Scientific Research: Invited by the Pathological Anatomy Service of the Faculty of Medicine of the University of Oporto, did an academic year (1999-2000) of scientific research at the Institute of Molecular Pathology and Immunology of the University of Oporto (IPATIMUP) through the Initiation to Scientific Research in Oncobiology and Pathological Anatomy Project (PIICAPO) sponsored by the Science and Technology Foundation (FCT), which lead to a publication in an international journal   Since 2003, continuous research in Implantology and Bone Regeneration Biomaterials field in association with the departments of Biomaterials, Dental Anatomy, Pharmacology and Biocompatibility of the Faculty of Dental Medicine, University of Oporto (FMDUP), Faculty of Engineering of the University of Oporto (FEUP), Institute of Biomedical Sciences Abel Salazar (ICBAS) and the National Institute of Biomedical Engineering (INEB).   Since 2012, continuous research in the Implantology field with the collaboration of Megagen Implants International.   In 2014 was invited to be apart of Megagen International Network of Education and Research (MINEC group)   Professional Experience - Dental Practice: Owner of private practice Dental clinics (Clinica Médico-Dentária RZ:JM, Managing partner) in Porto and in Albergaria- a- velha (Aveiro), performing Implantology, Surgery and Oral Rehabilitation exclusively, including patients of other referential colleagues.   Personal case series (including the numbers within the scope of the Specialisation Course at the Faculty of Dental Medicine of the University of Oporto) (FMDUP) from November 2002 to November 2015: performed implant surgery on several patients totalizing 3050 implants; 1870 tissue and bone regeneration procedures (autologous bone, heterologous bone, rich in growth factors plasma and biomembranes) and other surgical acts such as block graft (inlay and onlay), maxillary sinuses lifting and filling, apicoectomies, cysts removal, excision of soft tissue injuries, frenectomies, impacted canines and wisdom teeth extraction.   Teaching and Consultant Experience: Between 2002 and 2004- Teaching assistant for the theoretical and clinical subject Preventive Dental Medicine (3rd and 6th grades curriculum) at the Faculty of Dental Medicine of the University of Oporto. Within this scope, cooperated in the Organisation of Oral Healthcare programs at primary and secondary schools in Vila Nova de Gaia and special Oral Healthcare programs for disabled patients conducted at the Portuguese Association of Parents and Children with mental disabilities (APPCDM).   In 2007 was invited by Nobel Biocare and Dr. Pimenta to become a member of the Implantology training staff and did a private post graduation course on the Nobel Biocare (Nobel Active) implant, at the Faculty of Dental Medicine of the University of Oporto   Since 2011 is Megagen Implants Portugal clinical and technique consultant. (opinion leader)   Since 2012 is responsible for the education courses of Megagen Implants Portugal.   Professional Honours/Awards: Award for best scientific research poster in 2000 at the “Mucins in the pathophysiology of inflammatory diseases of the respiratory and digestive tracts” Symposium, under the title: “Mucins MUC1, MUC2, MUC5AC and MUC6 expression in gastric carcinoma”.   Award for best research poster in 2001 at the XII Oporto Dental Medicine Conference and Workshops.   Award for best oral research paper in the Portuguese Society of Oral and Dental Medicine Conference (SPEMD) in 2004, under the title: “New advances in guided bone regeneration by biomembranes”.   Honourable citation for the oral paper presented at the Portuguese Society of Oral and Dental Medicine Conference (SPEMD) in 2007, under the title ”Experimental Study of the MES biomembrane biocompatibility in lab rat”.   Award for best oral research paper in the Portuguese Dental Medicine Association Conference (OMD) in 2012, under the title: ““Evaluation of implant osseointegration in the treatment of peri-implant bone defects in rabbit ” Isabel Guerra, Fernando Branco, Mário Vasconcelos, Américo Afonso, Helena Figueiral, Raquel Zita Gomes   Professional Memberships  OMD : Portuguese Dental Medicine Association SPEMD: Portuguese Society of Oral and Dental Medicine APSO: Portuguese Association of Oral Health SPMDEV APMDH   www.gmdahub.com

Purpose: The purpose of this preliminary and descriptive study was toevaluate a biodegradable drug delivery system in combination with aninnovative ceramic implant. Methods: The delivery of gentamicin ofstandardized samples was measured in the laboratory usingultra-high-performance liquid chromatography. Biocompatibility andbiodegradation of the materials was investigated in an animal experimentin sheep up to 14 months. As carrier epsilon-caprolactone, 1:1 mixedwith gentamicin, intruded into micro-chambered beta-tricalcium-phosphatebeads (MCB (R)) was studied. Results and Discussion: Gentamicin wasreleased in calculable concentrations during the first 30 days. Therelease from epsilon-caprolactone was higher than that frompolymethylmethacrylate and more predictable. The caprolactone carrierwas reabsorbed by osteoclasts.

Interview with Travis T. Tollefson, MD, MPH, author of Artificial Muscle for Reanimation of the Paralyzed Face: Durability and Biocompatibility in a Gerbil Model

Monitoring cellular calcium levels by fluorescent probes has become an important method to visualize cellular signaling processes. The development of genetically encoded calcium indicators (GECIs) strongly contributed to the application of calcium imaging which in contrast to synthetic calcium dyes enables cell-type specific labeling, long-term expression and therefore chronic imaging approaches. Whilst GECI engineering and optimization mainly focused on improving signal strength or calcium affinities and kinetics, little is known about the magnitude of interference of GECIs affecting cellular calcium homeostasis in host organisms. Various previous attempts to genetically express GECIs using calmodulin-based indicators frequently resulted in pathological changes or decreased function of the GECI in the host organism. In contrast to calmodulin-based GECIs, calcium imaging studies in the nervous system of flies and mice expressing troponin C-based GECIs did not display detrimental changes. In this work, TN-XXL performance was confirmed by transgenic TN-XXL expression in a Thy1.2 driven mouse line which enabled chronic in vivo calcium imaging of sensory evoked calcium transients of layer 2/3 neurons of the visual cortex during monocular deprivation over weeks. In addition, a detailed analysis focused on TN-XXL expression, function, viability and biocompatibility in mice ubiquitously expressing TN-XXL under the β-actin promoter. TN-XXL expression was determined in almost all tissues examined and functionality was validated in a variety of cultured cell-types. In addition the applicability of ratiometric indicators for calcium imaging of dynamic and complex tissues was evaluated via the use of explants from developing and adult cardiac tissues. Moreover, the tolerance of long-term expressed TN-XXL was verified on cellular level and along with a genome wide transcriptional analysis and behavioral experiments TN-XXL biocompatibility was investigated with only minor effects on the host genome and behavior. Together this study not only establishes the first detailed combined observation of function and biocompatibility of a GECI ubiquitously expressed in a mouse model but also has set the foundation criteria necessary for the evaluation of transgenic mouse lines expressing GECIs. Transgenic TN-XXL expression in this β-actin mouse line further offers ease of use for calcium signaling studies in a variety of cell-types and tissues of pharmaceutical relevance. Moreover, the facilitated cell line production and the possibility to establish mouse line crossings with existing disease models can open new grounds for investigations of calcium related diseases in vitro and in vivo.

Mon, 1 Jan 2001 12:00:00 +0100 https://epub.ub.uni-muenchen.de/17019/1/10_1159_000014482.pdf Schiffl, Helmut ddc:610, Medizin