Very seldom do people focus on the process, details, or steps involved in launching precision health tests as a product. Instead, their main focus has always been the biological and scientific aspects involved in precision health.
However, rather than dwelling on the clinical laboratory angle or the algorithm of interpreting the test, this article will limit itself on the process and procedure of launching the complex test as a digital product. The article will delve into the challenges, the necessary resources, the cost, as well as the integration matrix for launching precision health as a product.
It is safe to argue that the process of launching preventive precision health care as a product is solidly founded within the precincts of data.
The evolution of the health care system all over the world has allowed precision health to restructure and reinterpret the scope of medicine. With precision medicine, diseases can now be accurately determined, predicted, averted, and even treated. Therefore, to create an elaborate integration matrix to launch the product, clear guidance on definition and design is necessary.
This is a very critical aspect of product development as it entails giving the user guidelines and defining the user experience. As we all know, the evolution of genetic treatment coupled with specificity and accuracy has enabled the delivery of achievement of treatment options that are highly operative and effective.
Step 1: Defining the Product
Through the process of product definition, the client base can be easily defined. This process necessitates that a clear definition of the business necessities and strategies be laid out. This includes a well-defined product value, the customer base, pricing approach, and attributes of the product.
This is important for the provision of patient-specific treatment, a key pillar of precision health. The provision of new and existential definitions is necessary for the advancement of newer and better versions of targeted drugs. Since the delivery of patient-specific and customized medical care packages is largely reliant on the evidence-based healthcare restructuring the acquisition of health data that is fine-tuned happens to be one of the targeted action plans.
This phase of defining the product is an elaborate process that takes between 1 and 3 weeks. The stage requires some crucial skills and human resources. This personnel is the legal counselor, business development manager, content writer, product manager, and the UI/UX Designer.
Step 2: Guidelines and Content Creation
With personalization and customization of medicine, the need for copious and vibrant molecular data, health data and clinical-generated patient data have fueled the potentiality and assurance that even greater milestones will be achieved in preventing and treating even worse conditions. As such, in the process of launching the product clear educational measures and guidelines needs to be provided to the end-user. In this regard, the legal team, the content writers, and the UI/UX designer are very important personnel and resources of this stage.
Step 3: User Experience and User Interface Designing
In this stage, the UI/UX designer will take from 4 to 6 weeks to:
To unlock the value of the user’s data, genetic data visualization instantly enables the presentation of complex datasets to be brought down to the layman’s level. And rather than encountering complicated terminologies like phenotypes and genotypes, the individual is presented with user-friendly information. This intuitive genetic data visualization allows the user to gain a deep understanding of the data assets at his disposal.
There is a need to engineer a product that will not only be patient-specific but also user-friendly. The following are the steps of the engineering phase:
Step 1: Front-End Development
The following pages should be incorporated into the patient’s portal:
Step 2: Back-End DEVELOPMENT
Needing an estimated 2 to 4 Back-End engineers, security engineer, and the project manager this engineering phase takes between 4 and 6 months to complete. These are some of the features developed in this phase:
Step 3: Cloud Engineering
The first phase of cloud development is the HIPAA cloud phase which should take an estimated 4 to 6 months. The personnel in this phase include the cloud and security engineers and the project manager. The phase must adhere to the Business Associate Agreement (BAA) regulations, as well as the cloud audit for compliance.
The following steps are crucial to setting up a HIPAA cloud:
Breaches: In case of a breach into the system and the patient’s ePHI is compromised, within 60 days the patient should be informed of the breach. Every PHI breach should also be brought to the attention of the Department of Health and Human Services.
In this 21st century, healthcare has evolved to heavily rely on data as an asset of immense value. The value of health data can be traced back to the understanding of the functional characteristics of human beings. The process of launching precision health in which data is of crucial importance call for the need to integrate third party services.
Consultation between CRM service providers and the engineering teams is a necessary ingredient in communication when developing precision health solutions. CRM services are crucial as they allow developers to develop a functional customer relationship. The Project Manager and CRM Salesforce Engineer, are the most important persons in this process and will take approximately 4 to 6 weeks.
The patient journey includes the following steps:
A CRM tool can have the following patient journey state set up in it:
The main features of notification are emails and text messages which entail reminders and follow-ups, platform and engagement notifications. Engineering teams usually integrate their product with Twilio or MailChimp. In this phase, the back-end engineer and the project manager will take a maximum of 2 weeks to create the system and integrate functionalities like:
Platforms like Stripe, Shopify, and Magneto play an important role in the checkout, inventory management, and e-commerce. This phase takes the project manager and back-end engineer between 1 and 2 weeks to integrate. Shopify, which is one of the most elaborate e-commerce platforms can be linked to the system using the following instructions once you have an account, store URL, and Shopify credentials:
Every health testing product has to be integrated with the Lab Information Management System or the Lab API. Precision health testing labs Integration necessitates that Backend Systems and Lab Systems have to communicate to enable the following processes:
This phase of launching seeks the services of a Bioinformatics Engineer, the Project manager, and the Backend Engineer. The whole phase takes between 4 to 8 weeks.
This phase will take the Project Manager and the Backend Engineer an estimated 2 to 3 weeks to integrate with a fulfillment center to offer shipping and tracking services. This process includes:
EHR is a preferable means through which precision health solutions can be launched. This call for the consolidation of the following functionalities which will enable successful integration of Precision Health Testing and the EHR system:
The necessary resources of this phase are the Project Manager, the BAA, and the Healthcare Systems Engineer. This will take them between 8 to 10 weeks.
Two important standards for precision health data exchange include:
This process will take the Project manager and the Backend Engineer and estimated 1 to 2 weeks. In this phase, the engineer will apply the FASTQ, VCF, and JSON formats to have a webhook notification service in the interpretation process.
With the unprecedented and growing concerns regarding the rising cybersecurity incidents and threats, it will be very imprudent if guidelines regarding precision health are not spelled out.
Implemented by the Backend, Frontend, and Security Engineers, this phase involves the integration of very high-level security features. The whole team will take a maximum of 8 weeks to develop:
The California Consumer Privacy Act (CCPA) and the General Data Protection Regulation (GDPR) compliance offers protection measures and general rules involving patients’ health data. These rules are particularly strict for health and genetic data which are categorized as particularly sensitive mostly for EU citizens and California citizens. The integration of these regulatory acts into the system involves cookie consenting, data collection authorization, etc. The process takes 3 to 6 weeks to implement and requires the services of a Project and Regulatory managers as well as the Frontend and Backend Engineers.
The Clinical Laboratory Improvement Amendments (CLIA) are the main regulations that govern precision health tests since they are all Lab Developed Tests. This phase can be accomplished by the medical practitioner who has contact with the patient. It can also be conducted by a board-certified provider network with the assistance of the Health History Questionnaire, Health History Questionnaire Approval/Rejection, and the Results.
The significance of the Health History Questionnaire is the approval of the end-user for the test. Thereafter, The LDT APIs will be used to send the questionnaire responses for approval.
The Health History Questionnaire Approval/Rejection allows the provider to either approve or reject the test on the basis of the received questionnaire responses.
The Results will be availed in the system for the provider to sign off once the tests are completed by the lab and the results are ready.
The end-to-end alpha and beta testing are necessary before the product is launched to the market. This way, any bugs on the product can be detected. Thereafter, a 24hr monitoring on the product is needed. This is done by the DevOps team where they monitor every update, analytics on the platform changes documentation, and much more.
The following are the functionalities of the operation and monitoring team:
ixlayer product and engineering teams have built a comprehensive solution to easily cover all these steps. Ixlayer is an end-to-end platform where biopharma companies, clinical labs, and consumer brands can offer their patients precision health services after every other step has been completed.
ixlayer is a robust platform where precision health care is realized by utilizing health data in a manner that simplifies the clinical health test. Taking into consideration the fact that health data can be broadly categorized as either dynamic or static, ixlayer compounds a blend of the two data types to the patient’s benefit and makes the patient the focal point thereby attaining the desired action plans stemming from the personalized recommendations.
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