Why? Because the concept is based on one of the most deeply rooted beliefs in society: each of us is unique and unrepeatable and our needs are unique to our characteristics.
The explosion of new analysis techniques and the measurement technology of the various conditions and parameters associated with personal health as well as the digitalization and the ability to analyze huge amounts of information is allowing the concept of personalization to go from being a chimera to having the possibility of applying in reality with some guarantee of success.
It is very important to take into consideration from the beginning of the development of a digital nutraceutical and the design of the clinical study that will analyze and will gather the information that will describe the consumption customer journey to think what the personalization strategy is going to be in order to avoid the posibles legal risks associated with how the personalization strategy will be communicated to the consumer of the product and how the personal data will be used in order to apply a personalized recommendation.
It is important to know the limits of the current state-of-the-art of the health measurement technology in order to really understand the health needs of an individual and the proposed solution to those needs.
Currently, we are in the infant state of the technology that will allow us to measure the health/wellness of a particular individual and understand what he/she needs to take or do to feel better or improve its current or future health/wellness.
So any solution that claims that with an analysis or study it can provide you with the program/product or solution that will improve holistically your wellness or health it is not taking into consideration the complexity of the issue or just sending a misleading message to the individual.
The current available techniques that claim that it can provide accurate solutions to a hidden or unmeasured preventive health/welness problem like nutrigenomics, metabolomics, and Xnomics are just analyzing a part of the system so the proposed solutions are not accurate enough and there is were the legal risks associated with an erroneous diagnosis.
In the personalization strategy there are basically 2 approaches:
- Holistic Approach: Determine what the individual lacks and what impact that lack has on his current or future health, and design an ad-hoc product to meet and satisfy that need.
- Approximation limited to a functional target and linked to the effect of a product on that functional target.
Undoubtedly, the first of the approaches is more attractive because it addresses the problem from a general point of view but has a great limitation and is associated with the current impossibility given the state of the art to have sufficient information of all parameters associated with the individual to make a recommendation that is accurate enough.
The limited approach to a previous functional target is not so conceptually attractive but it is the most appropriate and the one that can bring the greatest benefits to the consumer because it limits the space of necessary personal data to those that are associated with the functional target and that can also be measured given the state of the art.
Moreover, the legal risk associated with each of them is very different precisely because this legal risk is associated with the error that can be committed to identifying what elements or molecules the individual lacks and how to supply them. The difference in the error that can be made in the holistic approach to the functional target approach is very different and is the reason why the first approach is the most risky from the legal point of view.
Why? Because it can be considered in most cases as a diagnosis and, therefore, fall into the world of medical devices and medicines.
In the next article, we will talk about Monteloeder approach to personalization that has 4 different levels of approach and that avoids the legal risks associated with the consideration of medical device and the error in the proposal of the solution and diagnosis.
Monteloeder’s digitalization strategy have different levels of personalization:
- Habits related
- Identifying the type of customer and
- Tailor the dosage
Arturo Lizon Nordström, Ph.D
Chief Executive Officer