How integrated scientific assessment frameworks help build confidence in product safety[i] and performance through real-world evidence and continuous evaluation.
While tobacco harm reduction products and medical devices serve fundamentally different purposes and operate within their own distinct regulatory frameworks, both face the common scientific challenge of how best to assess product performance throughout their lifecycles using multiple complementary sources of evidence.
This challenge reflects a wider shift towards lifecycle-based assessment models, with regulators including the U.S. Food and Drug Administration (FDA) recognising the value of continuous evidence generation and real-world data, as well as robust quality control through the entire design and manufacturing process.
Laboratory testing and clinical evaluation remain fundamental to demonstrating product safety, quality, and technical performance under controlled conditions. These studies provide manufacturers and regulators with important data on device functionality, tolerability and intended use before products enter wider clinical settings.
Building a broader evidence base
However, as products become increasingly sophisticated and regulators place greater emphasis on lifecycle evidence generation, there is growing interest in more integrated, holistic, and standardised approaches to evidence generation. These approaches combine a wide range of different forms of scientific data, including laboratory science, clinical evaluation, behavioural insights, computational modelling, and post-market surveillance. Together, they help build a broader understanding of product safety and performance over time.
This type of lifecycle-based assessment by responsible manufacturers can help identify where additional evidence may be required as technologies evolve and new patterns of use emerge, supporting more continuous approaches to scientific assessment that extend far beyond initial product approval.
The six-stage framework explained
One practical example of this approach can be seen within tobacco harm reduction research, where smokeless nicotine products are assessed relative to cigarettes across multiple complementary stages designed to build a broader understanding of safety, quality, usability and long-term performance.
Strong product design and innovation principles set the stall before any wider testing begins. This idea of ‘safety by design’ is key in regulated product sectors, establishing expectations and guardrails for key elements including quality, performance, and risk management. These processes help ensure ensuing testing through Scientific Assessment Frameworks is able to benchmark against clearly defined expectations, objectives, and quality standards.
Imperial Brands’ own Scientific Assessment Framework (SAF) consists of six stages: product characterisation, biological science, clinical science, perception & behavioural science, computational science, and post-market surveillance. Running alongside each of these stages are a series of product safety assessment processes, to help ensure product quality and safeguard consumers.
Product characterisation forms the first stage of assessment before wider testing begins. This includes evaluating product quality, technical performance, design specifications and risk management processes to help ensure products meet appropriate manufacturing and safety standards.
Biological science then provides further insight into product interactions under controlled conditions. Laboratory studies are used to assess safety, functionality and performance before products progress into wider clinical evaluation.
If laboratory studies show no significant concerns, clinical science examines how products perform in intended-use scenarios. These studies may assess short-term safety, tolerability, performance and user acceptance under more realistic conditions.
Perception & behavioural science helps provide insight into how products are used in real-world environments. This can include assessing consumer perceptions, usability, satisfaction, adherence and patterns of long-term interaction, particularly for technologies that rely on consistent engagement to support intended outcomes.
Computational science supports multiple stages of assessment through data modelling and predictive analysis. This can help identify trends, simulate long-term outcomes and contribute to broader understanding of how technologies may perform across different user populations and environments.
Increasingly, computational science is also helping scientists ‘bridge’ data between products, extrapolating data from established datasets and evidence bases, using sophisticated modelling to help predict outcomes, and reducing reliance on new studies to generate entirely new datasets for every product iteration.
Finally, post-market surveillance supports continued monitoring once products are in real-world use. Ongoing evidence generation can help manufacturers and regulators assess long-term performance, product quality, and any remaining evidence gaps as technologies continue to evolve.
Lessons from integrated assessment frameworks
While developed to support tobacco harm reduction research, the SAF discussed above reflects broader principles that are relevant across sectors where monitoring and evaluating long-term product safety and performance, user behaviour and real-world evidence are important considerations.
While approaches may differ across sectors, integrated scientific assessment frameworks illustrate how multiple forms of evidence can be combined to support more holistic, impactful approaches to product development, evaluation, and monitoring to better inform manufacturers, reassure regulators, and benefit end users.
Beyond generating evidence at a single point in time, integrated scientific assessment frameworks also encourage ongoing responsibility for understanding how products perform throughout their lifecycle. This emphasis on continuous evidence generation and evaluation reflects a broader commitment to scientific stewardship and continuous improvement.
As approaches to medical technology assessment continue to evolve, integrated scientific assessment frameworks used in other industries may offer useful insights into how laboratory science, behavioural assessment, post-market surveillance and real-world evidence can be combined to support long-term product evaluation.
To find out more about their Scientific Assessment Framework, visit the Imperial Brands Science website or follow them on LinkedIn.
[i] Please note that in the context of this article, use of the word ‘safety’ refers specifically to product quality, and isn’t intended to imply that Imperial Brands’ smokeless products are risk-free (i.e. ‘safe’) from the perspective of absolute harm.
