As big data grows and competition rises, stricter regulatory guidance looms
Today’s medical device industry is being transformed by the generation and analysis of vast amounts of data. However, the traditional approaches to data collection and analyses in clinical trials don’t necessarily apply.
Along with this massive volume of siloed, disparate data comes unique challenges — from unstructured datasets and data ownership and privacy issues to storing global post-market surveillance data and adhering to evolving regulatory definitions and requirements.
These challenges demand the adoption of an integrated data platform at the beginning of a medical device development program. By doing so, it can help alleviate some of the current data challenges by enabling innovation, guiding regulatory pathways, and maximizing commercialization opportunities.
By engaging with an experienced partner, medical device manufacturers can leverage the opportunities of an integrated data approach and enhance their medical device program.
Integrated data can aid in product innovation
Integrating data from disparate datasets can provide novel insights and increase product innovation. For instance, digital biomarkers (consumer-generated data from device sensors) can support evidence-based outcomes and provide novel insights into real-world use when integrated with clinical trial data.
Sensors have been incorporated into more than 1,600 clinical trials (clinicaltrials.gov) as of August 2018, and this trend is projected to rise. Built into wearables and implanted devices to remotely collect data, sensors can support safety and efficacy data, in addition to serving as a resource for manufacturers to determine how to differentiate medical devices from that of their competitors.
Integrated data can also bring innovation to clinical data monitoring, providing information about device performance, malfunctions, and patient alarm systems. For example, with smart dressings for wound care, an effective integrated data strategy could provide novel insights about the healing process, thus informing additional product innovation.
Yet, integrating data isn’t easy. There are often many challenges. For instance, most datasets are largely unstructured, meaning they must be manually converted prior to aggregation, integration, and analysis. Other pain points include difficulties merging datasets, where more often than not, there is loss of valuable data, in addition to privacy and confidentiality issues.
These frustrations can be alleviated through regulated content management — an integrated end-to-end system that delivers the required process and ensures traceability, availability, high integrity, and confidentiality.
Integrated data can help drive and clarify regulations that foster innovation
The rapid innovation and growing complexity of medical devices is causing the need for regulatory agencies to evolve, adapt, and continually implement new guidances and models to strengthen device quality and patient safety.
Interestingly, integrated data can actually help to drive better regulations. For example, recent regulatory models from the FDA include NEST (National Evaluation System for Health Technology), which aims to uncover novel approaches to harness the power of integrated data, and the Care for Quality initiative, which seeks to address the gap between compliance and quality in the medical device lifecycle.
Also, the new European Union Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation are implementing additional requirements, moving toward stricter standards on safety. This could provide an opportunity for manufacturers to collaborate with regulatory authorities to continually refine new processes and guidances.
As regulations evolve, it can be difficult for manufacturers to stay abreast of the latest changes. In addition, the updated definition of device equivalence means that manufacturers will have to generate more clinical data for products, while facing the burden of acquiring post-market surveillance data.
Building a quality data program early on and having the ability to analyze data intermittently is key to reducing risk in clinical trials. Furthermore, this shows regulatory agencies that the study is testing quality proactively rather than as an afterthought.
Integrated data can maximize commercialization opportunities
Integrated data can foster commercialization of medical devices by supporting value-based claims and minimizing commoditization, improving post-market surveillance and global market access, and driving new models for product adoption and reimbursement. However, some roadblocks still remain. These include the following:
- Different regulatory agencies have different reporting standards
- Huge volumes of data from post-market surveillance can overwhelm data centers
- Going beyond traditional in-clinic data, such as medical images, X-rays, and scans requires a strategy to store and manage these new types of data
Using an integrated platform allows data to be readily accessible across different systems, which can reduce the resources required and can enable more seamless data configuration for different country reporting requirements.
Overall, the era of big data brings new and transformative opportunities to facilitate product innovation, to enhance regulatory pathways, and to maximize commercialization. Effectively integrating siloed and disparate datasets requires upfront planning and investment. Transitioning to a cloud-based unified platform can foster increased access to data, reduce costs, and enhance acquisition, integration, analysis, and reporting efficiencies.
Working with an experienced partner with a dedicated team of data scientists can help to develop the appropriate infrastructure, so manufacturers can better focus their efforts on bringing life-changing medical devices to market.
For more details on the current data challenges facing medical device manufacturers and how a unified platform enables faster market entry for new devices, download our white paper, “The Rise of Integrated Data in Medical Devices.“
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