Main Differences During New Product Development Between Medical Devices And Medicines
                     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]
Today's 
Discussion
OUTLINE OF TOPICS
In Brief  FDA
Introduction Medical Device Development and Drug Development
Akin to 
Prescriptio
n of 
Medicines
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.
Introductio
n
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 and
prescription of the drugs.
FD
A
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.
Source: Mahapatra et al.,
(2018)
Fig. 1 Different stages of medical device development and drug 
development
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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