The Life Sciences industry has always been fast-paced and competitive. Changes are influenced by the regulatory landscape, a need for lifesaving products as well as therapies and scientific advancements. Modern technology has enabled manufacturers to make products faster, with agile precision and quality. Maturing life science companies must learn how to use the power of new market disruptors to “keep pace” or perish in an innovative landscape.
Reflecting on 2019, we saw a focus on digitization which will continue to evolve. Furthermore, an increase in collaboration among the industry is resulting in collective efforts for transformation. For example, the FDA’s alignment with ISO 13485 to further harmonize current Quality Management System (QMS) requirements worldwide or the continued progress on issuing ICH Q12 that will be a huge game-changer for post-approval changes in the pharmaceutical space.
As 2019 ends, there are some life sciences trends we predict will continue into the New Year. Here’s what we can expect to see going into 2020 and the technology enablers that will help your organization keep up.
Digital transformation continues to dominate the industry and is essential to remain competitive. Cloud-based solutions drive R&D which helps bring new devices to market faster and ensuring continuous improvement in products and processes.
Using a cloud QMS, the industry benefits from having access data from anywhere in the world while collaborating seamlessly with suppliers and contract manufacturers. A QMS that integrates with suppliers will provide visibility into whether these suppliers are meeting your agreed-upon specifications and conditions. This insight enables organizations to proactively reduce the risk of noncompliance that is caused by poor supplier quality or materials.
Digitizing processes including document management, change control and training will streamline the control of data, demonstration of compliance and knowledge transfer. The catalyst for this is not limited to a culture of quality. In addition, digitizing is influenced by regulations that force us all to reflect on controls and practices. For example, the European Union Medical Device Regulation (EU MDR) and postmarket reporting requirements account for the entire lifecycle of a medical device or drug delivery system. We see this as a hefty influence on the need to digitize processes and data (e.g., clinical evaluation report) that has traditionally been paper-based.
A good Quality Management System (QMS) provider will enable the automation of your key processes while eliminating the need for mundane system administration. Instead, look for the vendor to perform these functions so you can focus on other critical areas of the organization and the change management that will make your implementation success.
2020 will continue to bring us more of this digitization through the online diagnosis and treatment of patients. We’ll also see the rise of virtual healthcare, where medications can be prescribed online and medical devices can be managed through the internet.
Medical Device Cybersecurity
A massive transformation in life sciences technology trends is happening in securing networked medical devices. These devices have transformed the industry, enabling providers to improve healthcare and provide a higher level of patient services than ever before. However, the increasing connection of medical devices has also made them vulnerable to outside threats like hackers and other security breaches.
In response, the FDA has released guidance to help ensure manufacturers create medical devices that are secure, reinforcing good design control. To proactively reduce the chance of a security breach, cybersecurity risks must be considered in the design of medical devices. Furthermore, a plan should be in place to manage risks throughout the entire product lifecycle including reporting cybersecurity concerns.
In today’s networked device landscape, cybersecurity should be a factor of an organization’s risk management process. Risk analysis and risk control strategy should take into consideration the chances and severity of a device that is being breached. As part of product surveillance, any resulting cybersecurity concerns should be reported immediately to the FDA. This can be expedited with an Electronic Medical Device Reporting (EMDR) system that reports any adverse, or potentially adverse event directly to the FDA.
Advancements in Data Management
Technology continues to streamline the way we manage data for efficiency as well as creating a single point of truth. In today’s quality environment, a system should quickly assemble, interpret and present data at the click of a button.
Manual processes increase the risk of human error, whereas automated document management enables access to information faster without sacrificing data integrity. Document control automates the process, maintains all data in a centralized location and allows only those with access to the ability to view and edit documents. In short, document management software effectively manages, organizes and sorts documents and builds traceability into each step of the documentation process.
For various technology solutions to work, they must connect so teams are not forced to operate in silos. System integration will continue to play a key part in the overall success of life science solutions. Integration prevents gaps in quality, produces faster results and reduces the chances of noncompliance.
For example, to keep pace with compliance, a corrective action process should integrate with risk management so a CAPA (Corrective and Preventive Action) can be initiated for a high-risk event. As another example, to ensure timeliness of any required medical device report, postmarket surveillance teams should have ready access to the necessary UDI. Integration with third-party systems and the supply chain extends collaboration, visibility, and compliance that leads to the efficient execution of your QMS.
Real-World Data and Evidence
Real-World Data (RWD) means data relating to the health status of patients as well as the delivery of healthcare. Real-World Evidence (RWE) is the evidence derived from RWD. Both will continue to play a pivotal role in making educated healthcare decisions.
The FDA uses both RWD and RWE to monitor adverse events and form the basis of making regulatory decisions. The 21st Century Cures Act emphasizes RWD- and RWE-based decision-making.
RWD and RWE will only continue to grow within the Life Science industry in 2020. A QMS that is built for compliance will continue to enable life sciences companies to make sense of the predictive data and ensure effective regulatory compliance.
Technological advancements like Artificial Intelligence (AI) have the power to change the way providers diagnose patients, plan treatments, monitor patients and more. It enables the life sciences companies to solve challenges related to drug safety and product development.
AI has accelerated drug development, reducing the time it takes to develop, manufacture and launch new products. It can also help assess trial and error pathways by identifying trends that lead to success. AI technologies within the life sciences manufacturing include robotics, biometrics, personalized digital experience and more.
To better align organizations and create a culture of collaboration with AI, a dedicated change control process will provide visibility, control, and implementation into the manufacturing process. In addition, integrating AI with the workforce will continue to help drive innovation within the Life Sciences industry.
As technology and regulations continue to evolve, those in the life sciences landscape must keep pace to meet the demand for efficient production of safe and innovative products. Technology tools put this power in the hands of the end-user and the benefits get carried down to patients who will continue to reap the benefits of this digital transformation.
To keep up with these market trends, organizations must continue to adapt to the ever-increasing pace of the industry. While technology has indeed accelerated the pace, it’s also given us the tools to keep up. An enterprise QMS will promote and facilitate collaboration between organizations, improving visibility and enabling innovation.