Seeing the extended applications of digital biomarkers, regulatory bodies are establishing a standard developmental pathway for them
In general, biomarkers or biological markers are defined as distinctive physiological features in an individual, which can be detected and quantified in order to gain insights about health and disease. On the other hand, digital biomarkers are defined as digital means that are employed to collect data about these unique biomarkers. These are combination of hardware and software features, like sensors, and wearables, that monitor the biomarkers and provide analytical insights about target indication(s). Similar to their traditional counterparts, digital biomarkers enable medical professionals to assess the health of patient and make relevant treatment related decisions.
Risk prediction biomarkers are of two types; firstly, there are those that based on current physiological conditions, are able to predict the likelihood of disease, and those that enable early diagnosis of clinical conditions prior to the onset of characteristic symptoms. The second category of digital biomarkers are related to specific diseases. Although there is a significant overlap, they can be further segmented into biomarkers that are used for diagnosis and those that enable healthcare professionals to monitor a specific disease during the course of treatment.
Digital biomarkers are believed to hold the potential to explore the previously untapped opportunities, for users, as well as healthcare teams. While users become more aware and capable of managing their health through the use of such solutions, their healthcare providers are enabled to provide more precise and patient-specific insights, in real-time, overcoming physical restraints.
Traversing a digital solution for biomarker from the R&D stage to the market is a long process. The various developmental stages involved in this process have been discussed in detail in the following sections.
- Discovery: Discovery is an initial and crucial step in the overall development process of digital solutions for biomarkers. In this step, novel solutions and its associated target indication(s) have to be identified. Further, it is important to understand the relation between a biomarker and target indication. Additionally, all methods to be used for gathering biomarker / bio-signal data are designed, along with protocols for subsequent experimentations, in this phase.
- Validations and Submissions: The validation phase can be categorized into two broad categories, namely clinical validation and analytical validation. These involve gathering real-world evidence, by carrying out a series of clinical trials for such solutions, in order to check efficacy and precision. Post successful outcomes in clinical trials, all data is submitted to regulatory authorities to gain marketing approval, which is vital in obtaining confidence of the end-users.
- Distribution and Marketing: The pharmaceutical, software, and medical device distribution / marketing system is an established network with well-defined channels through which manufacturers can reach the end-users of their products. Developers engaged in this domain are presently undertaking initiatives to create a well-structured distribution network for selling their offerings via B2B (healthcare providers, payers, employers and pharmaceutical companies) and B2C (patients and caregivers) business models.
