We are in the midst of a once-in-a-lifetime evolution in the life sciences market, driven by the demand for healthcare innovations that can be delivered faster, better and safer than ever before. It is critical for life sciences companies to begin upgrading technology infrastructure to support this transformation. I’ve worked with hundreds of organizations in this industry to reimagine how technology can accelerate the process of bringing life-saving products to market while maintaining quality. And I’ve seen firsthand that yesterday’s tools are simply not enough to stay ahead of the emerging diseases and chronic illnesses that continue to claim the lives of loved ones.

Why Now?

Digital disruption has finally made its way to healthcare and life sciences, due in no small part to the pandemic. Before, the industry used technology as another system of record, a digital alternative to paper-based processes. Most companies had enterprise resource planning systems, but infrastructure was siloed, and efficiency was limited by design. Speed was seen as a risk to quality and compliance.

Now, speed is oxygen in the life sciences market. When the pandemic hit, the unprecedented need for novel biotechnology solutions brought new entrants to the field and led to more cross-sector collaboration. The crisis also posed new challenges related to remote work, leading to an even greater need to break down information silos. The resulting market is more competitive but also more interconnected and interdependent than ever before. To keep pace, life sciences companies need to shift away from legacy systems of record and toward systems of engagement.

The Next-Gen Playbook

Tech stack improvements can jumpstart innovation and accelerate speed-to-market. Here’s how: The typical medical device, pharma and biotech company works with at least five supplier partners throughout the product life cycle. Most are manually pulling data streams together from their partners and internal teams. This is not only a waste of resources, but it also means critical business insights are buried in disparate data sets. Companies need a better way to facilitate collaboration, bring data collection online and do it at scale.

Enter the next generation tech stack for the life sciences. By contrast, next-generation tech stacks are integrated and automated. Software solutions are built to talk to each other, creating one central source of truth and supporting process automation. These systems are also designed to integrate changing compliance requirements, so teams can evolve with new regulations rather than live in fear of them. This way, teams can focus on bringing life-saving products to market rather than entering data and chasing down regulatory updates.

So what makes for the ideal next-generation tech stack in the life sciences? I’ve learned that the most agile stacks combine tools for customer relationship management, lab information management, project management and manufacturing automation—and then link it all together with a digital quality management system. This integrated approach provides several benefits: Because quality management is at the center of all these workflows, it supports more efficient collaboration and continuous process improvement at every stage of product development. It also aligns the relationship between quality and speed so that better compliance actually supports faster development and scalability. Visibility is what is required for quality to not slow things down, and trying to maintain visibility across several disparate systems means it takes time and people to bring all the information together for the best possible decision making.

Companies taking this approach are already seeing success: One organization we worked with prepared an entire FDA submission within seven days of implementing an integrated, next-generation tech stack. This implementation was quick and simple and helped them reorganize all their files in a way that enabled a very short turnaround on their 510(k). Having a fully compliant electronic system also means there’s no question about the traceability or integrity of the data they were submitting. They were able to integrate in real time from their quality system to their in-house project management workflow system and reduce their time to generate that submission by 90%. In a disconnected, isolated set of systems, compiling the necessary data points would have been slow and required many checks and rechecks to ensure accuracy. It also would have required the engineers working in the other systems to curate the data for the quality and regulatory teams, thus slowing down the day-to-day across the entire organization.

Today, many emerging medical device companies have one major advantage over larger, more established companies—they are often better able to embrace flexibility and innovation relating to processes and typical standardized best practices. To streamline this technology transformation, however, smart organizations will need to think about supportive critical changes that will need to be made in order to make this technology transformation seamless. For example, leaders in the life sciences that are looking to undertake a change to their tech stack must closely evaluate and consider the following.

1. Clarity: Have you undertaken the honest analysis and conversations that need to be had when it comes to the strengths and weaknesses of your current tech stack?

2. Team: Do you have the right people in place and leadership support in place to make this change a reality, or do you need to hire?

3. Communication: Is there a common understanding of the process necessary to support this change and the role each employee can play in helping make it a positive process?

The evolution of the life sciences market is already well underway. The ability to bring high-quality, life-saving products to market at a global scale—and to do it quickly—is now possible. Next-generation tech that is grounded with full integration and data sharing capabilities can help unlock speed and make it easier to maintain quality. To stay competitive in 2025 and beyond, life sciences leaders would be well-served to reassess their tech stack now and invest in new platforms and APIs in order to break down the silos that continue to hinder collaboration, data sharing and speed.