Medtech companies need risk intelligence to survive and thrive
18 December 2006
New York, USA. Life science companies (medical
devices, pharmaceuticals and biotechnology) must successfully navigate a
seemingly endless sea of risks to survive. They face demands from many
quarters: regulators, investors, partners, insurers, physicians, patients,
lawyers, and more. Meeting these needs adds complexity and heightens risk,
and as these risks converge and overlap, management of them becomes
simultaneously more difficult and more essential.
The key to overcoming
the hazards is intelligence, or more appropriately, Risk Intelligence,
according to Deloitte & Touche LLP in a new white paper: "The Risk
Intelligent Life Sciences Company". This provides life sciences executives
and directors with practical guidance and real-world examples of how to more
effectively address the industry's complex risk matrix.
every aspect of the life sciences industry," explains Terry Hisey, U.S.
Managing Principal of Life Sciences, Deloitte Consulting LLP. "Discovering
and developing new products entails high risk, given the heavy upfront
investments of money, time and expertise. Factor in the complexity brought
on by the pressures from patients, payers, physicians and the markets, and
now you get a picture of how challenging the risk environment is within this
Deloitte & Touche cites a number of fundamental steps
organizations need to undertake to create a Risk Intelligent Enterprise(TM).
The whitepaper also includes a section that looks specifically at the risks
in life sciences that arise around definable initiatives and occurrences,
which Deloitte & Touche calls "life events" for a life sciences company.
- research & development;
- product commitment; s
- cale manufacturing capability;
- merger, acquisition and divestiture; and
- unexpected occurrences.
A hypothetical case study of risks associated with commercialization
is also included to demonstrate a Risk Intelligent approach in action
within the life sciences industry.
"Becoming Risk Intelligent will
require people and systems to change the way they handle risk. Supporting
technologies are still in development, but the human factor is truly the
most imposing hurdle. Once executives and risk management professionals in
life sciences see the value of changing their thinking, behaviour, and
approach toward risk, the benefits soon become apparent," says Jody Noon,
National Practice Leader of Life Sciences & Health Care Regulatory, Deloitte
& Touche LLP.
The whitepaper is the fourth in a series on Risk
Intelligence developed by the professional services organization. It defines
the Risk Intelligent approach as follows:
- Recognizing and managing the full spectrum of risk an
- Minimizing "siloed" behaviour that can obscure an integrated
view of risk;
- Allocating proportionally more resources to the most strategic
and pertinent risks;
- Making sure risk management is an organizational-wide
responsibility and competency;
- Anticipating and preparing integrated responses to risk
- Managing risk with a view toward maximizing the upside of
strategic decisions while minimizing the downside.
Free copies of "The Risk Intelligent Life Sciences Company" may
be obtained at