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Building a next-generation tech stack for life sciences




Robert Fenton is the founder and CEO of Quario, a cloud-based quality management system (eQMS) for life science teams.


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

why now?

Digital disruption, in no small part due to the pandemic, has extended to healthcare and life sciences. Previously, the industry used technology as another system of record. It’s a digital alternative to paper-based processes. Most companies had enterprise resource planning systems, but their infrastructure was siled and efficiency limited by design. Speed ​​was seen as a risk to quality and compliance.

Speed ​​is oxygen in the life sciences market today. When the pandemic hit, the unprecedented need for new biotech solutions drew new entrants into the field and led to more cross-sectoral collaborations. The crisis has also brought new challenges related to remote work, further increasing the need to break down information silos. As a result, markets will not only become more competitive, but more interconnected and interdependent than ever before. To keep pace, life sciences companies must move away from traditional systems of record and toward systems of engagement.

next generation playbook

Improving your tech stack can fuel innovation and speed time to market. Method is as follows. General medical device, pharmaceutical and biotech companies work with at least five supplier partners across the product lifecycle. Most companies manually collect data streams from partners or internal teams. Not only is this a waste of resources, but it also means that important business insights are buried in disparate data sets. Businesses need better ways to facilitate collaboration, bring data collection online, and do it at scale.

Enter the next generation technology stack for life sciences. In contrast, next-generation tech stacks are integrated and automated. Software solutions are built to interact with each other, creating one central source of trust and supporting process automation. These systems are also designed to integrate with changing compliance requirements, allowing teams to evolve without fear of new regulations. This way, your team can focus on bringing life-saving products to market instead of entering data and tracking regulatory updates.

So what is the ideal next-generation technology stack in life sciences? The most agile stack combines tools for customer relationship management, lab information management, project management, and manufacturing automation, all with digital Learned to link with management systems. This integrated approach has several advantages. Quality management is at the heart of all these workflows, supporting more efficient collaboration and continuous process improvement at every stage of product development. And by balancing the relationship between quality and speed, better compliance actually supports faster development and scalability. Visibility is what you need in order not to compromise quality. Trying to maintain visibility across several disparate systems takes time and manpower to bring all the information together to make the best possible decisions.

Companies that have adopted 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 easy, and helped me reorganize all the files in a way that allowed for a very short turnaround for 510(k). Having a fully compliant electronic system also means there is no doubt about the traceability and integrity of the data they submit. They were able to integrate real-time from their quality system into their internal project management workflow system, reducing the time to generate their deliverables by 90%. With a series of decoupled, isolated systems, compiling the necessary data points took a long time and required many checks and rechecks to ensure correctness. Also, engineers working in other systems had to curate data for quality and regulatory teams, slowing down the day-to-day operations of the entire organization.

Today, many start-up medical device companies have one big advantage over the larger, established companies. They are often better able to embrace flexibility and innovation associated with processes and standardized, standardized best practices. However, in order to streamline this technology transformation, smart organizations should think about the key changes needed to make this technology transformation seamless. For example, life sciences leaders looking to change their tech stack should carefully assess and consider:

1. Clarity: Do you need an honest analysis and conversation about the strengths and weaknesses of your current tech stack?

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

3. Communication: Is there a shared understanding of the processes needed to support this change and the role each employee can play in making 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 quickly on a global scale is now possible. Next-generation technology, based on full integration and data sharing capabilities, helps you unlock speed and make quality easier to maintain. To remain competitive in 2022 and beyond, life sciences leaders must now re-evaluate their tech stacks and deploy new platforms and APIs to break down the silos that continue to impede collaboration, data sharing, and speed. should invest in

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