Healthy Context, LLC Information

Healthy Context, LLC (formerly Mobile Integrity Consulting, LLC) has been at the forefront of helping define and launch new digital health innovation for medical device manufacturers, healthcare providers and pharmaceutical companies. We provide strategy, solution definition, technology innovation, UX design, and market development consulting services as well as produce owner leadership on new commercializations leveraging lean/Agile methodologies. We have specific deep expertise in the areas of digital health (patient / clinician mHealth applications, IoT wireless enablement of medical devices, TeleHealth, home / self-care therapies, actionable clinical web dashboards, and EHR integration) and the underlying mobile, cloud services, big data analytics innovation. We customize overall connected health commercialization strategies, detailed product / service requirements, roadmaps and internal company leadership to execute and best navigate the FDA 510(k) / MDR process, risk / hazards, HIPAA and GDPR security / privacy regulations, product development, launch plans, and reimbursement pathway.