Abstract of Dissertation

Keyword : Medical Device Industry; Capitalization; Market Authorization; USA; Europe; FDA

Objective : Aim: To provide a general understanding of the similarities and differences of the market authorization procedure and patient access systems for medical devices in the US and Europe under various forces shaping the industry in both the geographies.” Objectives: • To understand the medical device market with focus on the global market need, potential benefits, and drivers and barriers in medical device industry • To examine, analyze and compare the market authorization and regulatory procedures in the USA and Europe • “To assess and differentiate medical device financing by the government and the reimbursement process involved for medical devices in the USA and Europe” • To study the emerging trends and their impact on the medical device sector in the US and Europe

Background : The ever growing need and the inexorable urge to improve quality of life, supplemented with the will to ensure the best possible health environment for human beings, have over the years nurtured the ever intensifying interest for medical devices, broadly defined as “any instrument, implant, in vitro reagent, apparatus or similar or any related article which are used for diagnosis, prevention, or treatment of disease or any other conditions, and which does not achieve its purpose through chemical action within or on the body”. More than 500,000 different types of devices in the field of healthcare are produced around the globe ranging from simple, everyday consumer products such as spectacles, dentures, to plasters and ostomy products, syringes and bandages, hip implants, MRI and X-Ray equipment, and pacemakers (Medtech Europe, 2016).” Medical device and equipment are a dynamic segment of both the USA and EU economies with the growth rate of the industry in both the regions dominating the global front with both the markets experiencing an uptick in this segment in recent years. The USA medical device industry is valued at more than $140 Billion in 2015 accounting for 45% of the global market while Europe contributes around 28% of the global market with EU-5 countries being the major shareholders constituting the major chunk of the market.” In this study medical device industry in both U.S and EU are compared on the following ground: 1. Market Authorization and Capitalization: Market authorization involves the entire comprehensive process from the development to the dissemination of medical devices. Marketing authorisation procedure encompasses: classification of medical devices based on some criteria, procedures for market authorization for different classes, registration of manufacturers and medical devices, marking of medical devices, time frame/period required for the completion of the entire process, post marketing requirements. 2. Patient Access and Reimbursement process for Medical Devices: Patient access is defined as the paying of the reimbursement money by a national or a third party payer to the manufacturers and making the medical device accessible to the patients. Reimbursement process has certain key attributes on which the comparison is made: regulatory bodies involved and the reimbursement process for medical devices in each geography. 3. Forces shaping the Medical Device Industry: This segment encompasses the medical device market overview in each geography, the healthcare providers landscape, the various decision makers involved in the procurement process for medical devices and the different trends dominating the market in different geographies.

Methodology : Study design and tools: a) Type of study: Systematic review of literature b) Study duration: The study is based at present i.e. the market authorization system, reimbursement process and the forces shaping the industry currently in action are studied. c) Data collection: Publicly available secondary research data sources were deployed

Recommendations : On a broader level the market authorization procedures in both the geographies have the same basic concept. In both the systems, the endeavor to gain market authorization increases with the perceived risk of the device and in both systems an existing equivalent device on the market allows for easier market authorization. On the other hand, many striking differences between both the systems can also be identified. An important difference is that market authorization and approval process in the USA is granted and handled by the FDA, a governmental body thus, making the authorization process a governmental responsibility, while in Europe market authorization for medical devices is handled by companies and designated and supervised by the authorities and are referred to as ‘Notified Bodies’. Additionally, in terms of technical requirements both the systems also differ. Although US is high on clinical investigation of the medical devices, the negative implication of this approach is that a lifesaving is withheld from patients in the USA who are in dire need of it, whereas the same medical device is available to the European patients.”.”” “Also, when comparing patient access and reimbursement model for both the geographies, it is shown that lower risk devices achieve market access in a comparable amount of time, the variation comes in term of the innovative and high-risk devices which require higher degree of clinical evidence and because of which the patient access time frame varies for the US and the Europe.” “In term of market share and growth, U.S medical device market is pioneer globally and is expected to retain its position in the subsequent years. After U.S, Germany stands second globally with the market share of 24.5 Billion USD.