While the development of medical and pharmaceutical devices not only takes time and money, it is also highly regulated. Selecting the right choice of material and process is essential in order to meet compliance regulations, ensure certification processes and reproducibility, and most importantly, provide a high quality product.
Dr. Bhatt will discuss several medical grade polymer materials which have been developed, exhibiting unique characteristics that offer extraordinary benefits over non-polymeric materials in the modern healthcare system. Additionally, these materials comply with global regulatory requirements that ensure they maintain their integrity without causing secondary and/or long-term complications in the patient. Using a specific case study, “Material Development for a Hip Implant Application”, Dr. Bhatt will discuss the development process and requirements to wade through the myriad of stages, and why the following 5 criteria must be evaluated thoroughly:
(1) product design and application specifications
(2) material properties and consideration
(4) regulatory and handling aspects
(5) manufacturing and quality plan(s)
About the Speaker
Dr. Bhatt has 24 years of global experience developing and introducing new products, building end to end engineering and manufacturing operations, and business incubators for regulated (medical device, food and beverage, automotive, and aerospace) and unregulated (semiconductor, consumer electronics, and 3D printing) industries.
He is a chemical engineer, holds a Ph.D. in polymer science and engineering, and was an industrial fellow within Industrial Partnership for Interfacial Materials and Engineering at the University of Minnesota.
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