Main Differences During New Product Development Between Medical Devices And Medicines

1. Overview Of The Main Differences During New Product DevelopmentBetween Medical Devices AndMedicines An Academic presentationby Dr. Nancy Agens, Head, Technical Operations, Pepgra Group: www.pepgra.com Email:sales@pepgra.com

2. Today'sDiscussion OUTLINE OFTOPICS In Brief Introduction Akin to Prescription ofMedicines FDA Medical Device Development and DrugDevelopment

3. InBrief 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 andbiotechnology.

4. Introduction Healthcare industry has undergone various transformations every time to launch a new medical device andmedicines. In a survey it was found that America’s biopharmaceutical research companies are tremendously working towards the invention of new medicine to save many patientslife. However, it was estimated that since 2000, FDA has sanctioned and approved more than 500 new medicines helping patients to live longer andhealthier. Many medicines are potential to cure various diseases like cancers cardiovascular disease and offering new options for patients suffering with diseases like Alzheimer’s andParkinson’s.

5. Akin to Prescription ofMedicines 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 variousaspects. It could be due to the underlying differences between medical devicesand prescription of thedrugs.

6. FDA The FDA play a key responsible role in regulating and supervising the safety of drugs, foods, vaccine, blood products, medical devices, biological medical products, dietarysupplements, radiation emitting products, cosmetics and veterinaryproducts. Another department Within the FDA is the Center for Devices and Radiological Health(CDRH) which ensures the effectiveness of medical devices and its safeuse. It also suggests to eliminate the products that emit various radiations which are hazardousto humankind.

7. Source: Mahapatra etal.,(2018) Fig. 1 Different stages of medical device development and drugdevelopment

8. Medical Device Development and DrugDevelopment Another important difference is product development where, medical devices are manufacturedby varieties of products by the healthcare professionals, which is approved based on their specific function, safety andefficacy. On the other hand, based on trial and discovery basis medicine preparation which is usually inthe form of pills, ointments, aerosols and solutions are developed by chemists and pharmacologistsin thelaboratories. Common Key RegulatoryDecisions for Approval: Is the drug/device safe and effective inits proposed use(s), and do the drug/device benefits outweigh therisks.

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