The
development of medical devices requires rigorous regulatory requirements,
careful planning and strategies for commercialization, pursuit for new
technology and improvements. While we
see various commercially successful medical devices in the market, no
comprehensive development model has been published.
Apart
from the company size and the market they share, medical devices companies have
a very similar strategy to develop and get their products to market. Scientific
researches about medical device project and development process are very good
references to the product development strategy of the companies and help them
to improve and validated their models.
Stanford
University’s researchers have studied the process of how medical technology is
brought to market. The model developed by Researchers
at the Stanford University Program in Biodesign divides the development in six phases:
“PREDEVELOPMENT, PHASE 0”
The clinical need must me
identified and understood by the inventors and devices companies, this phase
can be achieved, by direct observations, talking to patients or doctors. A
large list of medical needs is made based on market size, clinical impact, and
intellectual property.
“PHASE I: INITIATION,
OPPORTUNITY AND RISK ANALYSIS”
When the need is identified,
a review of all the perspectives is made. Market size, intellectual property,
competitive structure, financial resources, regulatory requirements, likewise
defining strategies.
“PHASE II: FORMULATION,
CONCEPT AND FEASIBILTY”
Concept definition and
feasibility take place in this phase, as well as strategies definitions. To
accomplish the concept definition, both brainstorming sessions and 3D CAD occur.
It is frequent to see the team’s marketing and the team’s R&D meeting with
potential users (doctors, nurses, technicians, patients and others) to catch
the clients’ attention. In addition, in Phase II we see the team of devices
companies defining and analyzing the risks that can happen during the project.
“PHASE III: DESIGN AND
DEVELOPMENT, VERIFICATION AND VALIDATION”
In this phase, the team
creates a test to verify and validate the concept, although the tests only
occur in Phase IV. These tests involve both engineering and quality tests. Many
steps of this phase are conducted and reviewed by members of clinical
regulatory departments, including FDA (in the USA). Likewise, the production of
documentary records.
“PHASE IV: FINAL VALIDATION
AND PRODUCT LAUNCH PREPARATION”
Final validation, final
product design and regulatory approval take place in this part of the process
that brings medical devices to market. Final product design must conform to
ergonomics standards. Quality system
starts working to define, document and approve the business, which contains
both product and administrative perspective.
“PHASE V: PRODUCT LAUNCH AND
POST-LAUNCH ASSESSMENT”
Before the launch, doctors
will have received training to use the new device. Once it has been approved
that the medical device is successful, both launch and distribution will take
place. With the new device been used widespread, literature and indications of
use are made and approved by FDA (in the USA). R&D has a main role in this
phase since the device requires continuing improvements.
Stanford University Program in Biodesign research was based in more than 80
experts in the private and public sectors, including industry representatives
and FDA officials.
Biokyra follows its own
product development process that is generically very similar to Stanford Model.
Each country has its own regulatory system so that the product development
process should adapt to those particularities.
References: http://medicaldesign.com/mag/
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