August 2nd, 2018 | Enterey

Irvine, California


Recent moves towards greater business agility have been driven by the need for life sciences companies to improve operational efficiency. With challenges such as greater pricing pressures, and increased competition in the industry, it’s no surprise that companies are looking for ways to improve and streamline their internal processes.


However, whilst operational efficiency is the leading factor in the move towards agility, the opportunity to improve other areas of the business should not be overlooked.


One such opportunity lies in compliance. Compliance is often seen as a business cost—a necessary step in the process of getting a product to market. However with the challenges currently facing the industry, compliance can be leveraged as a source of competitive advantage if companies are to meet their goals. Yet only those who are able to implement agile processes will be able to approach compliance in this way.

With an ever-increasing number of regulations to adhere to, a push for greater transparency, and increasingly diverse competition in the industry, companies must act now to ensure they are not left behind.

1. Greater business agility leads to a reduction in over-compliance.


Life sciences companies are inherently risk-averse. As a result, it’s not uncommon to see them over-comply in an attempt to avoid any compliance issues, regardless of the cost-benefit ratio.

However, too heavy a focus on compliance can leave companies at risk of ‘tunnel vision’, whereby business strategy is dictated by compliance rather than enabled by it.

Agile businesses, on the other hand, can be confident in their ability to spot and mitigate compliance risks. They do not feel the need to resort to over-compliance where each risk is equally weighted in their risk management efforts. Rather, they move towards a model of effective compliance—where risk is dealt with proportionately and optimally (rather than excessively).

2. Business agility enables companies to proactively adapt to compliance challenges


The life sciences industry is constantly changing in a way that few others are.

Regulations are frequently introduced or amended, meaning life sciences companies cannot afford to become complacent. A company that lacks agility, and the ability to proactively anticipate and manage compliance risk, will fail to adapt to these changing regulations. The results therefore, can be drastic.

Of the 65 respondents to KPMG’s Risk Management survey, 65% rated problems caused by new or existing regulations as ‘very high risk’ to their company’s global business operations.

However, a truly agile company can absorb the impact of, and adapt to, changes in the regulatory landscape a lot faster than its competition—giving it the competitive advantage every business strives for.

Additionally, with greater agility, both time and money can be redeployed to areas that require proactivity and investment, such as identifying business risks, planning new technology integration, or utilizing data to improve processes. Implementing better ways of working allows a company to mitigate compliance issues in the future.

However, taking this approach does not necessarily come easy to life sciences companies. It often requires complex process transformation, and skills/resources that the existing team doesn’t always have. In this case, companies may seek external consultants to develop and implement the changes.

3. Agile companies can generate more data which can be utilized to improve compliance


Technological developments continue to impact life sciences companies. Whether this takes the form of new product technologies that bring a greater diversity of competition into the marketplace, or enhanced analytics tools that allow companies to make more informed decisions, the true winners will be those who can incorporate technology and data to improve their operations.

If these improvements relate to key areas of compliance risk in a company they can, in turn, mitigate risks in the long-term.

However, integration of new technology is not straight-forward. Currently, many life sciences companies do not feel that technology aids their compliance reporting systems. 43% of respondents to Deloitte’s ‘Challenge Of Compliance in Life Sciences’ survey in 2017 did not believe their current reporting systems enable positive intervention (action to minimize the risk of non-compliance).

Life sciences companies must be sure they are integrating technology that will provide added-value, and that they have the correct set of skills to extract and interpret the data that this new technology brings. They must also improve IT infrastructure and systems, which can be a challenge if the company does not have the required business transformation expertise in-house.

Enterey works with pharmaceutical, biotech, and medical device companies to improve internal processes and reduce compliance risk. We streamline your internal processes, and liaise with internal teams to ensure technology integration is strategic and has a purpose.

For a life sciences consultancy with 15+ years’ experience in improving business agility, contact mike.ferletic@enterey.com



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