Sonia Veluchamy, CEO and Co-founder of Celegence discusses the increasing regulatory requirements and complexities faced by the medical device industry. Celegence works with companies to streamline their regulatory data management processes and adopt advanced technology solutions to manage compliance efficiently. Medical device companies are often slower than pharmaceutical companies to recognize the need to invest in data governance and process optimization to maintain compliance and avoid fines, delays in product approval, and loss of market access.

Sonia explains, "The awareness is there, but medical device companies have traditionally been a bit slower in adapting and bringing in consultancy, expertise, and technology. That is partly because the sector’s regulations have not evolved at the same pace as in the pharmaceutical industry. More recently, though, the regulations have become more complex. For instance, the requirements under the EU MDR- Medical Device Regulation – are very heavy in terms of the information that needs to be submitted on an ongoing basis. So, the industry is starting to recognize what it takes to maintain documentation, specifically detailing post-market surveillance activities, which is required to be compliant with the regulations worldwide."

"When you think about how medical devices are evolving, you get a sense of the growing complexity. For instance, there is now software that serves as a medical device. You also have AI being embedded into medical devices. But ultimately, it’s about ensuring that the products placed on the market are safe and efficacious. The ability to prove that via proper documentation is important. That, in turn, enables different regulatory authorities to feel comfortable with the products that are being approved and being marketed in each region."

#Celegence #RegulatoryAffairs #RegTech #RegulatoryStrategy #Pharmaceuticals

celegence.com

Download the transcript here

Dr. Ethan Korngold is the chief medical officer and divisional vice president of medical affairs at Abbott’s vascular business, which has developed a dissolvable stent technology to treat peripheral artery disease. PAD disproportionately affects Black and Hispanic communities and is often overlooked because early symptoms can be mistaken for other conditions. The Esprit BTK stent can help open up the smaller arteries below the knee and improve blood flow to the legs and feet to treat PAD and prevent severe complications and amputations.

Ethan explains, "So peripheral artery disease refers to blockages in the arteries to the legs. When those blockages build up, it’s because of cholesterol typically that builds up in the walls of the artery and causes limited blood flow. Initially, people can have cramping or soreness in their legs when they walk. That gets better with rest. As the blockages get worse, people can develop infections, ulcers, or non-healing wounds of their legs with what we call chronic limb-threatening ischemia. And ultimately, that can put people at risk for amputation."

"A lot of people aren’t aware of how common it is, and a lot of people aren’t attuned to the symptoms of it. People just sort of slow down. They do less and less, and they wind up being limited in their activities, and that really affects their health and their life, and ultimately, that can threaten their limbs. One of the things that Abbott is emphatic about is spreading awareness of the disease, trying to educate patients, trying to educate families, and trying to educate physicians so that people are more on guard for looking out for the signs and symptoms of the disease."

"We have been working at Abbott for many years on techniques to help open up these blockages in the arteries of the legs. They start at about the belly button and go all the way down to the toes. At the belly button, the iliac arteries are quite large. They are about a half an inch in diameter. And then, as they go down all the way to the toes, they get narrower and narrower so that they’re about a quarter of an inch to an eighth of an inch in diameter. There are a variety of different techniques to get through those blockages, such as using catheters, and wires balloons, and stents and scaffolds to help open up those arteries and change people’s lives. One of the biggest challenges in this space has been those smaller arteries below the knee."

#Abbott #AbbottVascular #PeripheralArteryDisease #PAD #DissolvableStentTechnology

abbott.com

PAD-info.com

Download the transcript here

Dr. Jonathon Hill, VP of Science and Technology and Co-Founder of Wasatch Bio Labs has developed the Next-Generation Sequencing 3.0, NESSI-Seq platform, which can analyze blood to detect epigenetic changes and provide insights into current health and predisposition for diseases. This native-read third-generation sequencing tool can provide longer sequence reads and analyze epigenetic modifications to DNA. Epigenetics can change over time in response to diet, environment, and lifestyle. Advanced genetic testing has the potential to provide biomarkers to support personalized medicine for earlier detection and tailored interventions.

Jonathon explains, "The biggest limitation with the Illumina sequencing was that it was only short sequences, so you had to get a lot of them to stitch them together and figure out what the human genome looked like. With this third-generation sequencing, we can get much longer reads, sometimes to the order of a hundred thousand nucleotide bases at a time. So we get these big complex reads."

"The other thing we can do now with this third-generation sequencing is look at certain chemical modifications the body makes to the DNA to help regulate that DNA and help the body function. And looking at those chemical modifications can tell us a lot about someone's health. It can tell us their age, and it can tell us what disease they might have. We can get a lot of information out of that that just wasn't available to us in the previous two generations."

"If you think of classical genetics, it's the DNA sequence and the mutations you might have that might give you a propensity for the disease, etc. Those don't change throughout your life. Every cell in your body has that exact same sequence from birth until death. It never changes. But the epigenetics, these chemical modifications change. They change as you age. They are different in different tissues and organs within your body, changing even in response to pathogens or certain disease states. So they have a lot of information that we would not get otherwise."

#WasatchBioLabs #Epigenetics #GeneticResearch #PersonalizedMedicine #DNAInnovation #GeneticTesting #NextGenSequencing #BiotechBreakthroughs #GeneRegulation #HealthcareInnovation #FutureofMedicine

Wasatchbiolabs.com

Download the transcript here