Overview of the Main Differences during New Product Development
between Medical Devices and Medicines
Dr. Nancy Agens, Head,
Technical Operations, Pepgra
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.
Keywords: Drug Development, Medical
Device Development, Variations
I. INTRODUCTION
Healthcare industry has undergone
various transformations every time to
launch a new medical device and
medicines. In order to achieve the
approval, these products are subjected to
few general rules to prove their efficiency
through a thorough supervision and
evaluation and then finally step into the
biotech market (Management, 2020).
Every patient struggling to overcome or
manage the chronic disease survives with a
hope that a day may bring better medicines
that can permanently cure the disease. In a
survey it was found that America’s
biopharmaceutical research companies are
tremendously working towards the
invention of new medicine which can
gradually improve patient’s health and
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
Copyright © 2020 pepgra. All rights reserved
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 (Pharma, 2019).
Akin to prescription of medicines,
medical devices are approved and
regulated by the Food and Drug
Administration (FDA). However, the
regulatory framework established by the
Congress for the medical devices is
flexible in various aspects, which could be
due to the underlying differences between
medical devices and prescription of the
drugs (Parliament, 2017).
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 (Sutton, 2011).
When a new medical device or
medicine is about to launch in market it
undergoes few stages that validate the
product. However, there are some basic
existing differences between the new
medical device and new medicine which
has to be launched and are based on
industry composition where above 80%
small and medium-sized companies
require medical devices and large
multinational organizations seek new
medicines. In general the active
components in medical devices are
materials used in mechanical and electrical
1
engineering tools, whereas, to produce a
new medicine the pharmacology and
chemistry composition are essential and
biotechnology,
genetic
engineering
techniques are essential. However, the
pharmacologic properties and action of
active ingredients in medicine is
understood based on pre-clinical and
clinical studies, standardised batch sizes,
manufacturing processes and starting
materials products that are stable and
generally stored at room temperature with
a long shelf life.
Fig. 1 Different stages of Medical device development and drug development
Source: Mahapatra et al.,(2018)
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
(Australia, 2020; Devices, Vitro, &
Medical, 2012) . Apart from the above
mentioned differences, U.S. Drug and
Device Development have listed major
developmental features which are crucial.
The pre-market approval is essential for
the high-risk medical devices which are
Copyright © 2020 pepgra. All rights reserved
grouped under Class III medical devices.
With Class III medical devices, the rate of
technology change, ease of in vitro
assessment, influence of physician
technique and ability to visualize
performance were found to have high
output than the new medicine which is
usually low. A single pivotal study is
enough to evaluate the efficacy of Class III
medical devices, but for a new medicine
two studies are required to cross check.
For Class III medical devices, a variation
in voltage is found through comparators
and for new medicine it was concurrent
control (RCT). It is difficult for Class III
medical devices to show its ability to blind
treatments than new drug which is easy. In
order to evaluate the Class III medical
2
devices, the study population size required
is small in 100’s when found with new
medicine which is large in 1000’s.
Moreover, to evaluate the total product life
cycle of Class III medical devices
consumes months-years and for new
medicine it takes years to decades.
Pertaining to pre market data use,
the New Devices follows 21 CFR
860.7(c)2 quotes that “Valid scientific
evidence is evidence from well-controlled
investigations, partially controlled studies,
studies and objective trials without
matched controls, well-documented case
histories conducted by qualified experts,
and reports of significant human
experience with a marketed device, from
which it can fairly and responsibly be
concluded by qualified experts that there is
reasonable assurance of the safety and
effectiveness of a device under its
conditions of use. The evidence required
may vary according to the characteristics
of the device, its conditions of use, the
existence and adequacy of warnings and
other restrictions, and the extent of
experience with its use.”
New Drugs follow 21 CFR
314.126, refers to sufficient reports
obtained
through
well-controlled
investigations which provided the proof of
"substantial evidence" in order to provide
the information on the effectiveness for the
new drug. However, a sufficient and wellcontrolled study uses a design that permits
a valid comparison with a control to
provide a quantitative assessment of drug
effect • Historical control designs are
usually reserved for special circumstances
• Uncontrolled studies or partially
controlled studies are not acceptable as the
sole basis for the approval of claims of
effectiveness.
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. What should the label contain? Is
the proposed labeling (package insert)
appropriate for the drug/device, are the
Copyright © 2020 pepgra. All rights reserved
methods used in manufacturing the
drug/device and the controls used to
maintain the drug's/device’s quality
adequate to preserve the identity, strength,
quality, and purity of the drug or the
durability, performance, sterility and
biocompatibility of the device (Laschinger,
2019).
REFERENCES
[1] Australia, M. T. A. O. (2020). Difference between
medical devices and pharmaceuticals. Retrieved
from https://www.mtaa.org.au/devices-vs-drugs
[2] Devices, M., Vitro, I., & Medical, D. (2012).
Differences between medical devices and drugs
Medical Devices In Vitro Diagnostic Medical
Devices
Drugs.
1–3.
Retrieved
from
http://globalmedicaltechnologyalliance.org/papers/
GMTA_Differences_Between_Devices_IVD_Dru
gs_RevFINAL_17July12-pdf-pdf.pdf
[3] Laschinger, J. (2019). Regulatory Pathways Devices
vs. Drugs Are there roles for registries? 1–17.
Retrieved
from
https://www.ctticlinicaltrials.org/files/session12_laschinger_regulatorypathways_regtrial_march3
0.pdf
[4] Mahapatra, I., Clark, J. R. A., Dobson, P. J., Owen,
R., Lynch, I., & Lead, J. R. (2018). Expert
perspectives on potential environmental risks from
nanomedicines and adequacy of the current
guideline on environmental risk assessment.
Environmental Science: Nano, 5(8), 1873–1889.
https://doi.org/10.1039/C8EN00053K
[5] Management, H. (2020). Health Management and
Leadership
promotion,
cross-collaboration
amongst key disciplines. Retrieved from
https://healthmanagement.org/
[6] Parliament, E. (2017). Medicines and Medical
Devices.
Retrieved
from
https://www.europarl.europa.eu/factsheets/en/shee
t/50/medicines-and-medical-devices#_ftnref1
[7] Pharma. (2019). Medicines in Development.
Retrieved
from
https://www.phrma.org/en/Science/In-ThePipeline/Medicines-in-Development
[8] Sutton, B. (2011). Overview of Regulatory
Requirements: Medical Devices - Transcript.
Retrieved from https://www.fda.gov/training-andcontinuing-education/cdrh-learn/overviewregulatory-requirements-medical-devicestranscript
3