Building organisational resilience in an evolving regulatory environment

Aaron Hoare Date published: May 03, 23

A Life Sciences perspective

Is preventing failure the best way to ensure success? Recent trends are pointing towards a simple conclusion: the most resilient organisations across the Life Sciences are thriving. That’s not to say that fortune no longer favours the ambitious. However, we are seeing time and time again that organisations who have resilience at their core are the ones who are most equipped to BE ambitious, driving growth.

In this article, you will also find our “5 steps to resilience,” giving you actionable advice on how to achieve resilience in your organisation.

The key challenges testing Life Sciences resilience

Over the past few years, it has seemed as though the only thing that we have been able to predict is that things will remain unpredictable. How can any organization be expected to thrive and grow when the next supply chain crisis, hike in the cost of operations, or natural disaster always seems to be around the next corner?

Just as Life Sciences organizations began to feel some stability following Covid-19, a disruptive mixture of new challenges has emerged. Some of the major issues currently affecting the sector include:

Global economic pressures

Energy prices are soaring. The war in Ukraine and China–US tensions are also adding to the strain when it comes to increasing operational costs. And with recession always looming, the natural response to cut costs is often counter-productive for ambitions of growth.

Extreme supply chain fragility

As a mixture of factors combine including high shipping rates, port congestion, product and raw material shortages, and geopolitical tension, getting the supplies you need is more taxing than ever before.

Severe talent shortages

Covid-related burnout and a growing demand for flexible working has seen talent drain from the Life Sciences, where hybrid and remote working can often prove a challenge to accommodate. What’s more, the Life Sciences are losing out to other industries as competition increases for digital and analytical brain power.

Cybersecurity and ethical considerations when using AI machine and language learning tools

We are entering brand new territory with rapid advancements in artificial intelligence tools. While they are proving valuable to many areas of the Life Sciences, they are bringing with them a new set of headaches as organizations struggle to keep up with numerous demands surrounding security, privacy, and the ethical use of these systems.

Constant regulatory change and uncertainty

Life Sciences organizations are constantly forced to react and adapt to a complex and ever-changing network of regulations. Just some of the recent and upcoming changes with significant implications for the regulatory landscape in the Life Sciences include:

• EU pharma reforms: Proposed changes to key European Union pharmaceuticals law will include stronger obligations for the supply of medicines and earlier notifications of shortages. These reforms have been delayed, but it’s only a matter of time before organizations operating in the EU will need tackle these changes.[1]
• FDA drug approval process: Ever-changing requirements laid out by the FDA are constantly placing demands on pharma organisations to strategize in new ways to manage risk. December 2022, for example, saw substantial change to the FDA’s accelerated approval process.[2]
• European Union Medical Device Regulation (EU MDR): Entered into application in May 2021, this affects medical device manufacturers in the EU and any organizations wanting to sell their products in the European marketplace. By 2025, no devices that aren’t certified to these standards will be permitted on the European market. Read more in our recent EU MDR white paper.

And several bodies are actively seeking to incorporate uncertainty into revised standards and guidelines by advocating a risk-based approach, for example:

• An updated ISO 15189: A new version of this key industry standard for medical labs has been published, now placing far greater focus on managing risk. All accredited labs will need to be thinking about their ISO 15189:2022 transition over the next 2-3 years. Read more about the changes on our dedicated ISO 15189 knowledge hub.
• ICH Q9 (R1): The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use have recently made changes to this Quality Risk Management guideline, namely three important new sub-sections on risk-based elements in Quality Management. [3]

Organisational resilience: a holistic approach

Meeting these sorts of challenges can seem daunting, especially when you don’t necessarily know what the next challenge will be. The good news is, building resilience and adopting a risk-based approach means you won’t need to be prepared for every single, ultra-specific risk and challenge you might face.

Adopting a holistic approach that moves away from a narrow focus on risk, controls, and governance will allow you to build a resilient, long-term strategy that looks at the environment as a whole. Combining this approach with robust quality practices will mean you can level out those “bumps in the road.”

Resilience then becomes a competitive advantage in times of disruption.

How does organisational resilience lead to growth?

The resilient approach isn’t about instant wins, but it is an approach about guaranteed, sustained success. The safety net of knowing you can confidently manage whatever comes your way will allow you to pick calculated risks safe in the knowledge that any setbacks can be worked through. By building resilience, you can look forward to:

• Knowing when to react and when to be ready: A risk-based approach builds contingency plans for common risks. But when you adapt this to a truly resilient approach, it becomes less about reacting as issues occur and more about being ready for them in the first place.
• Protected revenue streams in times of crisis: When the worst challenges hit, it’s almost impossible for revenue not to be affected. Having resilient, continuity measures in place to maintain a certain level of output can be the difference between survival and failure.
• Handling mergers and acquisitions with ease: A resilient organisation protects business continuity. A potential disruption is always posed if you carry out a merger or acquisition, but this can be mitigated through resilience.
• Picking up competitor revenue: If the next time your sector is disrupted, your key competitor stumbles but you keep delivering, guess who is going to be first in potential customers’ thoughts when contracts are up for tender?
• A stable organisational reputation: Our recent quality matters report highlighted how the consumer memory is long. A significant black mark on your organisation’s reputation if you fail to deliver on your promises can be felt for decades to come. 46% of respondents to the survey are still aware of the thalidomide scandal many decades after the scandal was a prominent news story, for example.

5 steps to resilience: quality management as a strategic driver for the whole organisation

What does all this mean for your organisation? First and foremost, we strongly advocate moving to a risk management mindset and culture with robust quality processes at its core. Resilience can only be achieved when you can anticipate and pre-empt risk. Robust quality processes alongside adopting a risk-based approach can be the key to unlocking resilience.

So, how can quality management become a strategic driver in your organization? There are five steps towards establishing a quality management system that builds true resilience. You may already find you are one or two steps along the process, but to build true organisational resilience, the fifth step should be the goal.

Looking to implement this approach in your Life Sciences organisation?

Ideagen offer the software solutions you need to achieve these aims. Our software gives you all the tools you need to build resilience. From establishing organisation-wide visibility of all the risks you face on a day-to-day basis, to establishing robust, documented quality control practices to meet regulations and adapt to regulatory change with ease: we have a solution.

Convinced? Book a conversation with our team so we can find the right Quality Management solution to support your organisation’s resilience and growth.

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Further reading
[1] EU plans changes to pharmaceuticals law to avoid medicine shortages | Reuters
[2] FDORA’s Changes to the FDA Accelerated Approval Program // Cooley // Global Law Firm
[3] ICH Guideline Q9(R1) On QRM Part 1 Formality Risk-based Decisions (outsourcedpharma.com)