Author Archives: Arthi G

Roles of Regulatory Affairs Specialist in Medical Device Manufacturing

Regulatory Affairs is one of the major departments in a company which plays a crucial role in getting the developed product released into the market. This varies from country to country and market to market. For example, the standards and regulations are different for different country like the FDA for USA, CE Marking for the European Union etc. So, when a particular product is getting developed itself it has to be done in accordance to these Standards and Regulations so that it can surpass these testing standards and get released into the market. On the other hand, when a product developed in one country according to their standards, needs to be exported or sold in a different country then the same product need to be tested and certified according to the target market/country’s standards. Thus the entire process of Regulations are simplified and made feasible typically by the Regulatory professionals.

It was a great experience being a part of the one of the world’s largest career fair held by The Society of Women Engineers(SWE) at Austin, Texas on 26^th and 27^th of October. There were around 320 exhibitors making it an absolutely fantastic experience for the students and the Industries to connect. Exhibitors from various sectors (Mechanical, Automobile, Computer Science, Electronics, Medical Device Pharma etc) were present at the fair and hence there were a good mix of participants from diverse educational backgrounds as well. It was a place filled with lot of energy and positive vibes as it was loaded with participants holding onto dreams and aspirations, trying hard to achieve their goals.

Researchers from the Universidad de los Andes in Chile have found promising results from the Umbilical Cord stem cells that could be used for non-invasive therapy. Heart failure which is marked by the heart muscle’s inability to pump blood efficiently, affects around 37 million people worldwide. Despite medical advances, half of patients diagnosed with heart failure are prone die within five years of diagnosis, according to Figueroa.

The Study

Physiologic and Engineering techniques are combined to provide personalized treatments for each patient to predict long-term results. A simpler way to visualize the idea is by imagining that, the doctor pulls up a virtual model of the patient’s heart on the computer and treats it with several drugs and a few moments later, she would be able to see how the heart is doing five years down the road.

The Study

A couple of researchers from The University of Kentucky Kenneth Campbell and Jonathan Wenk are working on building a multiscale simulation of heart by allowing the computer model to use MRI or Genetic data of the patients. They are granted a 3-million-dollar fund by The National Institute of Health.

The researchers at Johns Hopkins University School of Medicine are conducting a new study for manufacturing personalized medicine with the help of protein markers for varied level of Phosphorylation.

A form of heart disease known as heart failure with preserved ejection fraction (the amount of blood squeezed out when the heart contracts) impairs the heart’s ability to quickly and efficiently relax between “beats,” overworking the organ. The disease is estimated to impair circulation in more than 23 million people worldwide. Patients with ejection fraction issue preserved at baseline have particular difficulty when they try to increase their activity or exercise unlike the usual issue of shortness of breath that occurs in the other types of heart disorders.