Digital Solutions for the Biomakers market
by Crescendo Global Crescendo Global Leadership hiringSeeing the extended applications of digital
biomarkers, regulatory bodies are establishing a standard developmental pathway
for them
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.
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Created on Mar 9th 2021 23:07. Viewed 207 times.