|
Balancing Product Development
Effectiveness with Regulatory Compliance
Medical device companies are
experiencing growing pains as they navigate the challenging waters
of regulatory compliance while simultaneously keeping up with the
pace of innovation. When it comes to implementing product
development processes that comply with regulations, many have
overcompensated, resulting in overly-bureaucratic systems that are
impacting delivery performance and causing them to come up short
on time to market, R&D ROI, new product revenue, and schedule
predictability goals.
Though a single process design has
the advantage of one system for both business and quality system
needs, this approach increases opportunities for non-compliance
and hinders project teams that need flexibility to adapt business
processes to specific project needs.
Implementing a program that couples
product development effectiveness with compliance is no easy task,
but deploying a methodology that includes improvements in process
definition and work flow structure, innovation governance and
decision making, project teams and team structure, and software
systems and tools can help companies realize benefits including:
Meeting and exceeding development effectiveness goals, Achieving
time to market goals ,Hitting planned product launch dates,
Eliminating unnecessary process bureaucracy as well as
Accelerating product development process maturity.
A mature, high performing product
development process with low compliance burden is the goal. Top
performing medical device companies demonstrate how to achieve
this goal and deliver safe, effective, and commercially successful
medical devices.
(Ref:
http://ww2.frost.com/files/3914/2200/7195/Beyond_Compliance.pdf)
* * * * *
|
