Main 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 sales_at_pepgra.com
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Today's Discussion
OUTLINE OF TOPICS In Brief Introduction Akin to
Prescription of Medicines
FDA
Medical Device Development and Drug Development
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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.

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Introduction
Healthcare industry has undergone various
transformations every time to launch a new
medical device and medicines. In a survey it
was found that Americas 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
Alzheimers and Parkinsons.
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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.
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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, 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.
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Source Mahapatra et al.,(2018)
Fig. 1 Different stages of medical device
development and drug development
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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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