Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector {Mr.Shantanu Kumar Singh Director, Taj Pharma Group)}

In-depth review on ‘innovation and regulatory challenges of the drug delivering medical devices’

Patel Drashti, Charmy S Kothari, Singh Shantanu, First Published December 22, 2018 Research Article (https://doi.org/10.1177/1741134318821143)

Abstract

The medical device market is generally seen as an area with high growth potential and provides greater profit margins including significant positive benefits to the patients. As the medical device regulations and the guidance document are becoming stringent in the US, manufacturers of these types of products are now facing these conundrums along with a need for clarification on matters related to various drug and device provisions. The European Union is making major changes to the Medical Device Directive which is its regulatory scheme for devices. Some parts are focused on the medical devices. The new changes in the regulations represent an important step forward in the growing philosophy of medical devices in Europe. Along with the regulatory challenges, there are various challenges faced during the innovation of such products. There are many factors that affect innovation including the patent aspects. In general, the key thing is that small firm face lots of difficulty compared to larger firm in bringing medical device in market. Thus, the proposed manuscript focuses on understanding the regulatory issues in various countries for ease of innovation and marketing authorization of medical devices.

About Author:
Mr.Shantanu Kumar Singh (Executive Director, Taj Pharma Group); BA (Hons), MBA, M.Phil, England , U.K.; LLB/LLM; based at Mumbai and Ahmadabad. Extensive experience working with Deutsche bank, pharmaceuticals investment banking; Specialties: Pharmaceuticals Market Launches, Pharma Sales, financial consulting and corporate venture capital. International Corporate Communications and Mass media management.

Keywords Medical device regulation, development, regulatory challenges, US, EU