Regulatory & Marketplace
Barriers in Medical Device Innovation Introduction: Abstract: Every day, innovative new technologies can and do transform industries, and due to the massive technological innovations like the web, smartphones and communication technology, the rate of change has increased. But not all companies are created equal as regards creativity. The healthcare industry is extremely complex and due to rising costs and patient demands, the medical care delivery environment is under growing pressure. Such stresses and the industry's inherent existence itself make healthcare development more complex than it is in the consumer products market. To break through the complexities of medicine and drive science forward, inventors and medical testing and production firms must first resolve the many obstacles to the creation of healthcare products. Knowing how medical devices interact with humans is a critical problem that influences both the design and acceptance of innovative new technologies and the regulation. The FDA classifies medical devices into three classes: the first two classes do not have much regulatory requirement, but class three has a main hurdle which should pass the regulatory requirements for marketing of the product. During the early generations, the regulatory requirement for marketing of medical devices was much less compared to the present situation; now it requires to pass many regulatory hurdles which is a very big barrier for medical device innovation because there is no proof that it will pass through the regulatory hurdle. Keywords: Medical device, Innovative Barrier
body; or a tool intended for internal or Barriers in innovation of medical devices A medical device is described as a medical product which, via pharmacological, external use in human or animal disease cause a massive problem globally. For immunological or metabolic achieves its primary intended effect in on or the on or disorder, diagnosis, treatment,means, mitigation example, if a medical device is not 2 or market the treatment for someordisease or theprevention. human body; or a tool intended for internal orand external use in human animal disorder is not available; most barriers relate disease or disorder, diagnosis, treatment, mitigation prevention. (2) Example to medicalor efficacy review, distribution of the Substances used for in vitro diagnosis product, and manufacturing of the medical Example: and surgical dressings, surgical bandages, device with good quality, regulatory oversight. surgical staples, surgical sutures, ligatures, blood and blood component collectionand surgical Anotherdressings, hurdle is surgical questions relating Substances used for in vitro diagnosis bandages, bag with or without anticoagulant and to intellectual property rights (IPRs). The surgical staples, surgical sutures, ligatures, blood and blood component collection substances like mechanical contraceptives extensive testing that the US Food and (condoms, devices, tubal rings), Drug Administration (FDA) or the European bag with intrauterine or without anticoagulant and substances like mechanical contraceptives disinfectants and insecticides. Notified Bodies require represents large (condoms, intrauterine devices, tubal rings), disinfectants and insecticides. and risky financial commitments. The final History financial outcome of investments may History: The first “medical device” invented was be uncertain even after positive clinical the thermometer in 1603 by Galileo. In 1819 testing, as payments for products and Thestethoscope first “medical device” thermometer in 1603 Galileo. In the (wooden) wasinvented invented was by the services are not assured by by reimbursement Rene, real breakthrough when mechanisms. may require 1819 and the the stethoscope (wooden)was was invented by Rene,Reimbursements and the real breakthrough there was the discovery of X-rays in 1895, more research, recording a beneficial cost was the when there was of X-rays in 1895, thenforthe invention of the then invention of thethe ECGdiscovery in 1903, which / benefit analysis patients, healthcare is still used in all hospitals. There are more providers, or even for the broader society. ECG in 1903, which is still used in all hospitals. There are more than 14,000 than 14,000 different products, according to The cost of such studies is often the liability different products, according to Global Medical Nomenclature. Global Medical Device Nomenclature. of theDevice fabricators of products.5
There are four types of classification of medical devices in India and Japan: (4)
There are four types of classification of medical devices in India and Japan:4
But according to some countries like Europe and the USA, there are only three classes:1
ButInnovation according to some countries like Europe and the USA, thereadding are only three Innovation isisnot about introducing something new but also value to notonly only about introducing something new but also adding value to it. classes: (1) it. It should be useful and feasible. Innovation and new product development are It should be useful and feasible. Innovation the lifeblood of thedevelopment R&D department of an industry. and new product are the lifeblood of the R&D department of an industry. Ideas for change also come from consumers and experts who are most familiar
with the issues that need to be addressed. Most ideas are received from clinicians
Introduction A medical device is described as a medical product which, via pharmacological, immunological or metabolic means, achieves its primary intended effect in or on the human
Ideas for change also come from and healthcare solve consumers andproviders experts to who aretheir mostproblems by innovating new products. familiar with the issues that need to be addressed. ideas are received devices from cause a massive problem globally. For Barriers in Most innovation of medical clinicians and healthcare providers to example, if a medical device is not on the market and the treatment for some solve their problems by innovating new products. disease or disorder is not available; most barriers relate to medical efficacy
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review, distribution of the product, and manufacturing of the medical device with Autumn 2020 Volume 12 Issue 3 good quality, regulatory oversight.
