Global Medical Device Regulatory Strategy
55 Regulatory Affairs Professionals Society
Using the information collected, the team should
analyze the relevant data for each element identified
in the content list, paying careful attention to those
elements that do not appear to meet the project
team’s needs (or desires). In particular, the planned
market release dates may not be coordinated with the
projected review processes. See Figure 4-1 for the
countries wherein the Target Release Date does not
follow the completion of the regulatory review. These
elements may require more supporting data than the
ones matching project team assumptions.
For example, the product plan often underesti-
mates a particular market’s review time. The project
team will want the review to be as quick as possible.
Team members may have had previous experience
with a similar product and have mental benchmarks
on the review time length or have misinterpreted rel-
evant published data. If review time data are available
for similar products, experienced regulatory personnel
should analyze reviews of other products over an
appropriate time period. Providing an answer based
on proper data interpretation rather than individuals’
experiences will lend credibility to the estimate and
decrease the opportunity for debate when the GRS is
presented.
The element table should be reviewed before
starting research. Two new columns can be added:
Analysis Result and Presentation. Analysis results
drive both the presentation’s nature and how it is
incorporated into the GRS and regulatory plan. A
simplified example of the expanded element table is
shown in Table 4-4.
Communicating the Strategy
Once the team collects and analyzes the information
for creating a regulatory, it must be communicated
clearly. The audience is likely to be a range of com-
pany stakeholders. Not all audience members will
want to review a 25-page report. A two-page execu-
tive summary of conclusions at the beginning of the
report will make the information easier to understand
and absorb. Graphic presentations also are simpler to
understand quickly. References should be added to
show data sources and provide greater credibility.
Summary Presentation
The Device
A summary should describe the device briefly, includ-
ing any features or benefits critical to the product’s
success.
The Big Picture
To present an overview of each country’s review
process timeline, a presentation like the one in Figure
4-1 can provide an easily understood comparison
Figure 4-1. Comparison of Target Market Release Timelines
Created by Melissa Walker. Source: Graematter, Inc.
55 Regulatory Affairs Professionals Society
Using the information collected, the team should
analyze the relevant data for each element identified
in the content list, paying careful attention to those
elements that do not appear to meet the project
team’s needs (or desires). In particular, the planned
market release dates may not be coordinated with the
projected review processes. See Figure 4-1 for the
countries wherein the Target Release Date does not
follow the completion of the regulatory review. These
elements may require more supporting data than the
ones matching project team assumptions.
For example, the product plan often underesti-
mates a particular market’s review time. The project
team will want the review to be as quick as possible.
Team members may have had previous experience
with a similar product and have mental benchmarks
on the review time length or have misinterpreted rel-
evant published data. If review time data are available
for similar products, experienced regulatory personnel
should analyze reviews of other products over an
appropriate time period. Providing an answer based
on proper data interpretation rather than individuals’
experiences will lend credibility to the estimate and
decrease the opportunity for debate when the GRS is
presented.
The element table should be reviewed before
starting research. Two new columns can be added:
Analysis Result and Presentation. Analysis results
drive both the presentation’s nature and how it is
incorporated into the GRS and regulatory plan. A
simplified example of the expanded element table is
shown in Table 4-4.
Communicating the Strategy
Once the team collects and analyzes the information
for creating a regulatory, it must be communicated
clearly. The audience is likely to be a range of com-
pany stakeholders. Not all audience members will
want to review a 25-page report. A two-page execu-
tive summary of conclusions at the beginning of the
report will make the information easier to understand
and absorb. Graphic presentations also are simpler to
understand quickly. References should be added to
show data sources and provide greater credibility.
Summary Presentation
The Device
A summary should describe the device briefly, includ-
ing any features or benefits critical to the product’s
success.
The Big Picture
To present an overview of each country’s review
process timeline, a presentation like the one in Figure
4-1 can provide an easily understood comparison
Figure 4-1. Comparison of Target Market Release Timelines
Created by Melissa Walker. Source: Graematter, Inc.