Launching a genetic product

Launching a genetic product is an expensive, complicated, and time consuming effort. There are several layers and steps required to launch and operate a product:

  • Development Time

    5-8 months for product development, integration, and testing. 6-12 months to get CLIA certification for health products.

  • Development Cost

    $400k-$900k development and $300k annual operation cost. $250k for getting CLIA certification including additional operation cost for a mandatory CLIA lab director.

  • Required Resources

    Resource needed includes frontend, backend and IOS developers as well as designer, product or project manager, and devops.

  • Regulatory Requirements

    Healthcare products need integration with physician network. Getting CLIA certification for all states. Having a lab director for annual CLIA audits.

Launching a genetic product with and without ixLayer

These are layers and steps required to launch and operate a genetic product without ixLayer.

Interface layer

  • Content & assets

  • Design UI/UX

  • Frontend development

  • Mobile development

  • Notification services

  • User scenario testing

  • Policy user flow

  • Alpha testing

  • Launch testing

Backend layer

  • Backend source code

  • Database architecture

  • Genetic Labs APIs

  • Physician APIs

  • Genetic counseling API

  • Integration testing

  • Security & Encryption

  • AWS architecture

  • Server load testing

Science & Regulatory

  • Scientific Evaluation

  • Result validation

  • LDT flow

  • Exclusion criteria

  • Interpretation

  • Physician approval

  • Genetic consulting

  • Lab Director sign off

  • CLIA certification

Operation layer

  • Platform updates

  • Userdata access

  • Platform Analytics

  • Integration management

  • Certificate management

  • Source code updates

  • Monitoring & logs

  • Security patching

  • Post launcht improvement

Launching a product with ixLayer

With ixLayer all that is needed from your side is the scientific or clinical claims.

Ix360

ix360 is an End-to-end solution that has everything you need to launch a genetic product. This includes:

Custom product design

ixLayer's product and design team will work together with you to create the interface and the experience that fits your users needs. This includes product brainstorming, identifying value propositions, design that speaks for your brand and a feature-rich product for your genetic application.

Web and Mobile

With ixLayer you can offer a custom web, mobile-web and Native IOS application, integrating with Genetic Labs, Apple payment services, Apple Health & Research-kit, supporting one or multiple genetic products.

Increase your products visibility by making them available on the App store. Collect phenotype data from mobile phones, wearables and connected medical devices to improve your result's quality and validity.

Integrated with the ecosystem

Fully integrated with all needed services to launch a genetic consumer product or genetic health product. These services includes Genetic sequencing platform, physician networks, on demand genetic counselors, CLIA certified interpretation and reporting, and compliance with HIPAA guidelines.

Hands off Operation

Running operation post launch inducing daily DevOps, platform updates, admin userdata access, platform analytics, Integration- and certificate management, source code updates, monitoring & logs, security patching, post launch bug fixes, API versioning, and updates from supported services.

Launch your genetic product today

Details of ix360 end-to-end solution

The following table highlights services for consumer genetic products or health lab developed test (LDT) genetic products:

Consumer

Health

Product concept & ideation

Our product team will guide you through product concept and ideation, value proposition, features, functionalities, and product criterias.

Design & UI

Custom user interface and user experience based on product concept and your recommendations.

Web Application

Front-end dynamic mobile responsive web development based on design.

IOS Application

Native IOS application (Swift) integrated with genetic labs mobile SDK and apple payment services.

App store launch

Launching your App on Apple App store including App submission and Apple approval process.

Apple Healthkit

Integration with Apple Healthkit in order to collect phenotype data from your end user to improve your results quality and validity.

Apple Research-kit

Integration with Apple Researchkit in order to perform research and/or clinical trials on your user base.

Multi product launch

Launching more than one product or genetic test on the same App.

Genetic Labs integration

Integration with genetic labs service- and genomics-API. Including integration testing, and load testing.

LDT integration

Integration with physician Lab Developed Test (LDT) API for obtaining exclusionary-criteria mandatory for health products.

Physician network integration

Integration and data routing to physician-network APIs for Lab Developed Test (LDT) exclusion criteria approval

Genetic Counseling integration

Integration with genetic counseling services & APIs

Security compliance

Passing security compliance mandatory for launching HIPAA compliant health products.

Scientific interpretation validation

Supporting you to validate the interpretation algorithm, mandatory for launching genetic health products.

Product Alpha testing

Launching your product in staging test environment for debugging.

Genetic Labs launch approval

Authentication credential exchange and completion of genetic labs launch approval.

CLIA document screening

Lab director reviewing product claims and workflow to make sure it meets regulatory requirements.

CLIA document management

Lab director evaluating records of patients testing to make sure it is properly maintained and all procedures, and policies are under document control.

CLIA Audit

Routine auditing to demonstrate that our personnel have proper qualifications, quality management program is implemented, and our lab operates with the highest standards of quality, accuracy and consistency.

Product Beta testing

Private launch with a closed internal test group.

Daily operation

Server and system operation, including monitoring and diagnostics. System-related update and maintenance.

Client Admin access

User data access, platform analytics, sales reporting, conversion, and funnel information.

3rd party service updates

Integration management, genetic pipeline updates, service API updates.

Operation Security

Certificate management, source code updates, logging and monitoring, and Security patching.

Post launch improvement

Post launch bug fixes, product and content improvement. End-user price changes.

Apple app store updates

Update IOS app based on new Apple OS releases. Content update on Apple app store

Launch your genetic product today