The COVID-19 pandemic forced organizations to find new ways to maintain R&D efforts and increase production capacity while reducing on-site personnel to prevent the spread of the virus. Digital transformation presented a viable and scalable solution to that challenge, enabling many organizations to do more with fewer resources. However, that alone will not be enough for manufacturers in the life sciences to succeed in 2023.

With the emergence of a "triple squeeze" on performance caused by high inflation, a shortage of skilled labor, and a constrained supply chain, manufacturers in the life sciences will need more than automating data collection and performing tasks remotely to remain competitive. Improving efficiency, boosting productivity, and staying ready to pivot to changes are at the top of the priorities list. Fortunately, with new technology and capabilities arising every day, manufacturers in the life sciences have an excellent toolkit to help them achieve those missions and solidify their competitive advantages beyond 2023.

Here are the trends we have seen adopted by leading manufacturers in the life sciences as they seek to increase their resilience, amid labor challenges and everchanging supply chain challenges, and how they might help you successfully navigate the “triple squeeze” on performance.

Investing in interoperability

Many manufacturers are still stuck with isolated data sources within their operations. In situations where legacy equipment cannot connect to the internet, data must be manually recorded, leading to inefficiencies and delays. As a result, manufacturers often devote entire departments to gathering and analyzing data from various systems, such as MES, QMS, and ERPs, to produce reports that may be up to a week old by the time they are completed. This is a major waste of resources and incurs significant delays in processing time, not to mention the opportunity loss due to using outdated data in the analysis. Under pressure to fully utilize their resources and better optimize processes, organizations are taking strides to eliminate data silos with a more unified data ecosystem.

By investing in interoperability, manufacturers can improve their operational efficiency and gain a competitive advantage. Interoperability enables systems to communicate and share information, allowing for better work order tracking, inventory management, and access to bills of materials (BOMs) from a single app. This saves time and increases productivity by eliminating the need to switch between tasks and systems.

Contrary to the popular belief that it takes time and significant system investments to achieve interoperability, manufacturers can utilize an operations platform instead of point solutions to integrate and exchange data easily. Operations platforms like Tulip utilize HTTP APIs, SQL databases, and OPC UA servers for easy data exchange through configurable connectors. By streamlining data management and analysis, manufacturers can spend less time searching for information and more time gaining insights into how their operations are performing and how to improve it to achieve even better efficiency.

Increased cloud adoption

Manufacturers in the life sciences are shifting away from managing traditional on-premise systems that require significant resources to cloud service providers. With unpredictable supply chain issues and a scarcity of trained IT professionals, managing an on-premise system is challenging even for the largest companies. To adapt and make quick, impactful decisions, manufacturers must turn to the cloud, which allows them to gain flexibility, efficiency, and agility.

Cloud computing allows manufacturers to quickly scale up or down their computing resources as needed, giving them flexibility without investing in new hardware or infrastructure. This can be especially beneficial for companies that experience fluctuations in demand for their products, which is one of Deloitte’s predictions for the manufacturing industry in 2023.

With cloud computing, manufacturers in the life sciences with distributed teams or operations in multiple locations can increase efficiency by giving their employees, partners, and customers remote access to their IT systems and data. With the ability to access powerful applications and advanced analytics from any location via the internet, organizations can leverage the power of artificial intelligence and machine learning to gain insights and drive innovation throughout the entire life sciences value chain.

Many cloud vendors offer services that comply with various regulations and standards, such as HIPAA, FDA or ISO. Regular software updates ensure the most modern security protocols are in place to protect against malicious software. If a manufacturer’s systems were damaged in a catastrophic event, cloud vendors can provide disaster recovery insurance and high availability to minimize downtime by storing data across multiple locations.

By using cloud-based services, manufacturers can focus on their core business objectives without worrying about the maintenance and security of their IT infrastructure.

Mass production to mass customization with digital workflows

Additive manufacturing and technological innovations in research and development have made personalized treatments viable and scalable. Customized medical devices and gene therapies can provide the best recovery results, minimize side effects, and lower overall healthcare costs, which has the potential to revolutionize the healthcare industry and significantly improve patient outcomes. However, even successful cell and gene therapy companies and customized medical device manufacturers may need help in keeping up with changing demand, commonly due to a lack of an effective frontline operations platform.

To make the shift from mass production to mass customization requires manufacturers to deploy flexible systems to manage their operations. Flexibility ensures systems fit around processes rather than the other way around, and a common first step to achieve that is through the digitization of workflows.

Manufacturers who have yet to digitize may have a binder of work instructions that require operators to jump back and forth between many pages depending on the work order. Digitizing these workflows not only can improve efficiency but also connect disparate data sources, reduce errors in workflows, and provide visibility into production processes, making customization feasible.

The new level of agility brought by the digitization of workflows will allow manufacturers to adapt to an unpredictable market and meet the demands of mass customization.

Continuous software updates with accelerated validation workflows

Validation is expected to remain a challenge for life sciences in 2023 as regulations continue to change and expectations for quality continue to rise. Traditionally, validation efforts have been time-consuming and costly for manufacturers in the life sciences, leading to a build-up of technical debt as they struggle to keep their software up to date. That’s why many organizations have shied away from implementing new digital tools despite significant operational efficiency gains.

Moving to digital is no longer optional for 2023. Like other sectors, life sciences needs a significant boost in efficiency to mitigate the negative impact of inflation and supply chain disruptions. For that to happen, they need new validation workflows that can be done in an accelerated timeline without compromising quality or disrupting operations. That new workflow is validation for the intended use.

Software that can be validated for intended use instead of following the traditional step-wise process will be a prominent presence in the life science manufacturing scene in 2023. By using software that is equipped with the latest features to improve productivity and simplify compliance, manufacturers can shorten validation cycles and make rapid upgrades to increase functions and values. This will be a key driver of agility and ensures manufacturers continue to stay ahead of their competitors without breaching necessary regulatory standards.
Example digital history record application

Building trust through increased transparency and accountability

During the COVID-19 pandemic, manufacturers in the life sciences faced challenges in increasing vaccination rates due to a lack of trust from the public in their products, brands, and leadership. Even though vaccines were developed at an unprecedented pace, the lack of trust made it difficult to effectively distribute and administer the vaccines. Complex research and development processes, failed clinical trials, and opaque pricing can all contribute to a lack of trust in the life sciences industry. It is important for manufacturers to address these issues in order to rebuild trust and ensure the success of their products.

Trust is essential in the life sciences industry, and manufacturers must take steps to earn the trust of their customers. One way to do this is to consistently adhere to industry regulations and provide strong scientific evidence backed by data integrity. Paper-based operations no longer suffice with the increasing amount of operational data that needs to be stored, secured, and processed to establish transparency and accountability. Paper-based records are prone to errors, are insecure, difficult to collaborate on, and can easily be damaged, making it difficult to meet these standards. Many manufacturers are transitioning to electronic batch or device history records to overcome these challenges. This form of documentation offers immediate benefits by error-proofing data capture through edge connectivity and enabling review-by-exception workflows to accelerate batch releases. By adopting electronic records, manufacturers can improve compliance, reduce errors, and build customer trust.

Tips for getting started with your digital transformation initiatives

Tulip is a cloud-based, GxP-ready platform designed to help manufacturers become more adaptive. It allows users to easily create applications with IIoT, edge connectivity, and AI/ML analytics capabilities using a no-code app configuration. Tulip's human-centric workflows enable powerful functionality to support frontline operators and improve operational efficiency.

By implementing Tulip, manufacturers can gain resilience against the triple squeeze and even expand their operations while others struggle to keep up. Tulip is an effective solution for manufacturers looking to improve their operations and stay ahead of the competition.

If you’re ready to improve the digitization of your pharmaceutical manufacturing facilities, get in touch for a free consultation with Tulip’s pharmaceutical industry experts.

Improve quality and simplify compliance with Tulip

Learn why pharmaceutical manufacturers are leveraging Tulip to digitize documentation, improve quality, and streamline compliance activities.

Day in the life CTA illustration