Medicines and Medical Devices Regulation – current developments and future options
Differences During New Product Development Between Medical Devices And Medicines
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Overview Of The Main Differences During New Product Development Between Medical Devices And Medicines An Academic presentation by Dr. Nancy Agens, Head, Technical Operations, Pepgra Group: www.pepgra.com Email: [email protected]
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With high-risk medical devices listed under Class III medical devices, pre-market approval is necessary. The rate of technology change, ease of in vitro evaluation, impact of physician technique and capacity to envision results were found to have high output with Class III medical devices compared to the new medicine which is usually low.
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Transcript of Differences During New Product Development Between Medical Devices And Medicines
Overview Of The Main Differences During New Product Development Between Medical Devices And MedicinesAn Academic presentation byDr. Nancy Agens, Head, Technical Operations, Pepgra Group: www.pepgra.comEmail: [email protected]
OUTLINE OF TOPICS
In Brief
Introduction
Akin to Prescription of Medicines
Today's Discussion
FDA
Medical Device Development and Drug Development
In Brief
Medicines and devices that are supposed to be launched are based on industry composition where above 80% small and medium-sized
companies require medical devices and large multinational organizations seek new medicines. One of the fundamental variations refers to the active
components within medical devices (similar components are used in electrical and mechanical engineering tools). On the other hand, drug
development involves knowledge of chemical, pharmacological, genetic engineering and biotechnology.
Introduction
Healthcare industry has undergone various transformations every time to launch a new medical device and medicines.
In a survey it was found that America’s biopharmaceutical research companies are tremendously working towards the invention of new medicine to save many patients life.
However, it was estimated that since 2000, FDA has sanctioned and approved more than 500 new medicines helping patients to live longer and healthier.
Many medicines are potential to cure various diseases like cancers cardiovascular disease and offering new options for patients suffering with diseases like Alzheimer’s and Parkinson’s.
Akin to Prescription of Medicines
Akin to prescription of medicines, medical devices are approved and regulated by the Food and Drug Administration (FDA).
The regulatory framework established by the Congress for the medical devices is flexible in various aspects.
It could be due to the underlying differences between medical devices andprescription of the drugs.
The FDA play a key responsible role in regulating and supervising the safety of drugs, foods, vaccine, blood products, medical devices, biological medical products, dietary supplements, radiation emitting products, cosmetics and veterinary products.
Another department Within the FDA is the Center for Devices and Radiological Health (CDRH) which ensures the effectiveness of medical devices and its safe use.
It also suggests to eliminate the products that emit various radiations which are hazardous to human kind.
FDA
Fig. 1 Different stages of medical device development and drug development
Source: Mahapatra et al.,(2018)
Medical Device Development and Drug Development
Another important difference is product development where, medical devices are manufactured by varieties of products by the healthcare professionals, which is approved based on their specific function, safety and efficacy.
On the other hand, based on trial and discovery basis medicine preparation which is usually in the form of pills, ointments, aerosols and solutions are developed by chemists and pharmacologists in the laboratories.
Common Key Regulatory Decisions for Approval: Is the drug/device safe and effective in its proposed use(s), and do the drug/device benefits outweigh the risks.
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