Fostering Innovation and Compliance in the Life Sciences Industry - 3 key considerations

Life Science companies are often regarded as a laggard in digital transformation topics. Considering how heavily this industry invests in R&D, this is an unexpected situation.

Regulators are often pointed as the guilty party. It's no secret that there has long been a conflict between innovation and regulation, which is frequently portrayed as "good" vs. "evil," with claims that regulations stifle innovation.

This does not have to be the case all of the time. Regulations are concerned with safety and risk reduction in an industry where patients' lives and well-being are at stake, whereas innovation seeks to introduce new ideas and products, which introduce new risks. But it is possible to be both innovative and compliant, and both serve a noble purpose and are required.

Regulation's challenges should be viewed as an opportunity to reconsider business models and be even more inventive in order to provide better tools and processes to enable all parts of the value chain.

Here are some key factors to consider when driving innovation and compliance in the pharmaceutical industry's digital transformation:

1. Regulations and guidelines must be thoroughly understood: Rather than dictating what must be done, these regulations frequently simply ask for proof of controlled processes and appropriate risk management practices. This implies that there may be room for innovation in terms of conformity.

2. Focus on secure interoperability: Regardless of compliance requirements, effective and secure information sharing across departments, stakeholders and systems is critical for driving innovation, efficiency, and agility. It can also help to improve data management and analysis, which can support regulatory compliance. Similarly, having foundational and robust data security and privacy policies and practices that can be reused across the value chain will save time and effort later on.

3. Adopt agility: Use iterative approaches to incrementally test and refine your products.The key is to allow for experimentation and to enable teams to learn and respond quickly. However, be practical. Scrum teams are not required for all processes and teams. Agility does not imply working from PoC to PoC. without delivering value. Use simple but effective measures to qualify ideas and evaluate their merits before granting additional investment or discontinuing it entirely.

To summarize, regulations should not be used to justify a lack of entrepreneurial and innovative spirit. On the contrary, there are ways to encourage more creative and inventive workplace practices while remaining compliant.

It's a "and" not a "or"!