Global Medical Device Regulatory Strategy
49 Regulatory Affairs Professionals Society
endless resources, it is important to prioritize the
entry into the targeted countries.
Every plan is made with certain assumptions. The
team must understand which assumptions, if shown
to be false, would result in the project’s failure.
For example, Competitor A will be in the
European Union (EU) within 1 year. Its new device
includes a key design feature that has the potential
to shift market share in its direction. Your product’s
continued success depends on getting to the market
first with this key feature to protect your market
share. The product is similar to your current product,
but several changes are planned before being released
onto the market. Development can proceed quickly,
and the product can be ready in 9-10 months. Any
additional time due to a review delay will mean the
market window has closed and Competitor A may
take market share. The company’s plan assumes:
• Competitor A will deliver on its plan in 1 year, and
• Your product modifications will not require more
than the 9-10 month cycle, including develop-
ment and regulatory body oversight (if needed).
If Competitor A delivers faster than its plan, your
company can lose the race. If the product modifi-
cations needed require prior review, your company
also may lose the race. While the project proceeds,
the team should pay careful attention to these
assumptions, adjusting the GRS on a regular basis if
conditions change.
Another example. An adverse inspection has
resulted in closure of the competitor’s facility. The
company that can increase production to cover
the product volume can lock in a multiyear supply
contract. The product requires prior review from
regulatory authorities, as it is a Class III/high-risk
product. To accommodate demand for the product,
your company must expand production to a new facil-
ity that will supply products in multiple geographies.
The plan assumes regulatory approval in one of the
major markets (United States (US), EU, or Japan)
must be received within 6 months. Without the
multiyear supply contract which will, over time, cover
the cost of the expansion, the project is not financially
feasible. In this case, the key assumptions are:
• The multiyear supply contract can be obtained,
• The new facility receives regulatory approval for
production, and
• The regulatory status of the competitor’s facility
does not change, allowing them to restart pro-
duction prior to the new facility.
Other types of limitations also will affect the GRS.
Product plans for the same product may be very
different based on the company’s size and nature. For
example, how would a GRS differ for the follow-
ing: a small company (fewer than 50 employees,
venture-funded, no currently marketed products),
or a large company (more than 10,000 employees,
profitable, fully developed product lines currently
marketed)?
Small, venture-funded companies often have
scarce time and resources. The first product may have
enough features and capability to get clinical use get-
ting a product’s first iteration on the market can mean
the organization’s continued viability. A 6-month
delay means the company has fewer resources for
commercial launch. Larger companies may not be as
sensitive to similar time or resource constraints, as
their continued viability is not at risk.
In any case, make a what-if list of the devel-
opment or regulatory events that could change the
assumptions that drive the GRS. For example, iden-
tify the priority for the new design features. Which
ones could be pushed to the next iteration if the
release schedule accelerates?
The variations are virtually endless. Unless the
regulatory strategy considers the limitations built into
the plan, the project is designed for failure.
Regulatory History
Questions to be answered:
• Are similar devices already in (or out of) the
target marketplace(s)?
• What data were required for existing devices’
clearances or approvals?
• How long were the review processes?
• Who manufactures or distributes similar devices?
• Have the existing devices’ manufacturers had
findings or observations during regulatory or
conformity assessment bodies’ inspections (those
who make audit or inspection reports publicly
available)?
• Were clinical studies required?
• What are the common types of device failures?
• Have there been any recalls of existing devices?
• What guidance documents or performance stan-
dards are available?
• Does the device have any other uses apart from
the targeted indications?
Researching the regulatory history of a medical
device can be very time-consuming. This is espe-
cially true when the product plan includes multiple
countries. It is a simpler process if the GRS is for
an extension of an existing product line in the same
target countries, rather than an entirely new prod-
uct type. If no internal product history exists, each
country will require more research. Countries publish
49 Regulatory Affairs Professionals Society
endless resources, it is important to prioritize the
entry into the targeted countries.
Every plan is made with certain assumptions. The
team must understand which assumptions, if shown
to be false, would result in the project’s failure.
For example, Competitor A will be in the
European Union (EU) within 1 year. Its new device
includes a key design feature that has the potential
to shift market share in its direction. Your product’s
continued success depends on getting to the market
first with this key feature to protect your market
share. The product is similar to your current product,
but several changes are planned before being released
onto the market. Development can proceed quickly,
and the product can be ready in 9-10 months. Any
additional time due to a review delay will mean the
market window has closed and Competitor A may
take market share. The company’s plan assumes:
• Competitor A will deliver on its plan in 1 year, and
• Your product modifications will not require more
than the 9-10 month cycle, including develop-
ment and regulatory body oversight (if needed).
If Competitor A delivers faster than its plan, your
company can lose the race. If the product modifi-
cations needed require prior review, your company
also may lose the race. While the project proceeds,
the team should pay careful attention to these
assumptions, adjusting the GRS on a regular basis if
conditions change.
Another example. An adverse inspection has
resulted in closure of the competitor’s facility. The
company that can increase production to cover
the product volume can lock in a multiyear supply
contract. The product requires prior review from
regulatory authorities, as it is a Class III/high-risk
product. To accommodate demand for the product,
your company must expand production to a new facil-
ity that will supply products in multiple geographies.
The plan assumes regulatory approval in one of the
major markets (United States (US), EU, or Japan)
must be received within 6 months. Without the
multiyear supply contract which will, over time, cover
the cost of the expansion, the project is not financially
feasible. In this case, the key assumptions are:
• The multiyear supply contract can be obtained,
• The new facility receives regulatory approval for
production, and
• The regulatory status of the competitor’s facility
does not change, allowing them to restart pro-
duction prior to the new facility.
Other types of limitations also will affect the GRS.
Product plans for the same product may be very
different based on the company’s size and nature. For
example, how would a GRS differ for the follow-
ing: a small company (fewer than 50 employees,
venture-funded, no currently marketed products),
or a large company (more than 10,000 employees,
profitable, fully developed product lines currently
marketed)?
Small, venture-funded companies often have
scarce time and resources. The first product may have
enough features and capability to get clinical use get-
ting a product’s first iteration on the market can mean
the organization’s continued viability. A 6-month
delay means the company has fewer resources for
commercial launch. Larger companies may not be as
sensitive to similar time or resource constraints, as
their continued viability is not at risk.
In any case, make a what-if list of the devel-
opment or regulatory events that could change the
assumptions that drive the GRS. For example, iden-
tify the priority for the new design features. Which
ones could be pushed to the next iteration if the
release schedule accelerates?
The variations are virtually endless. Unless the
regulatory strategy considers the limitations built into
the plan, the project is designed for failure.
Regulatory History
Questions to be answered:
• Are similar devices already in (or out of) the
target marketplace(s)?
• What data were required for existing devices’
clearances or approvals?
• How long were the review processes?
• Who manufactures or distributes similar devices?
• Have the existing devices’ manufacturers had
findings or observations during regulatory or
conformity assessment bodies’ inspections (those
who make audit or inspection reports publicly
available)?
• Were clinical studies required?
• What are the common types of device failures?
• Have there been any recalls of existing devices?
• What guidance documents or performance stan-
dards are available?
• Does the device have any other uses apart from
the targeted indications?
Researching the regulatory history of a medical
device can be very time-consuming. This is espe-
cially true when the product plan includes multiple
countries. It is a simpler process if the GRS is for
an extension of an existing product line in the same
target countries, rather than an entirely new prod-
uct type. If no internal product history exists, each
country will require more research. Countries publish