Services

Healthy Context, LLC is a strategy, product / service realization and technology consulting firm focused exclusively on Digital Health innovation across the Patient, Provider and Payor value chain. The firm helps define and bring to market mHealth applications, Internet of Things device connectivity, advanced clinical and operational systems for Providers, big data analytics and visualization and interactive communication services that drive new levels of patient, care partner and clinician engagement. Traditional advisory services are also complemented by execution plans with hands-on leadership to help guide organizations to success with new user-centric products, services and technologies in market.

Execution is key and we embrace the latest techniques from Lean Innovation, Agile development and modern DevOps cloud realization. Every product or service needs a champion to successfully drive things to market and we help establish the necessary rigors and can even assume a Product Owner function to help augment your organization's current capabilities. Healthy Context has a diverse skill set traversing the user experience definition, deep technology and architecture decisions, regulatory and privacy / security requirements; all of which are required to uniquely launch impactful and differentiated digital health innovation.  

Healthy Context offers a range of services to medical device providers, healthcare providers, pharmaceutical companies, infrastructure providers, early stage startups and 3rd party research firms. Services are customized to meet the particular needs of each client with short or longer-term assignments including project based and staff augmentation models within a given organization.

Strategy Formulation

  • Customer discovery and value proposition validation
  • Market analysis and competitive offering assessments (products, services and technologies)
  • Existing product portfolio alignment and feature roadmap timing
  • Go-to-market strategies and product positioning
  • Business case analysis and pricing/licensing strategies
  • Strategic plan and risk assessment
  • Business Model Canvas tooling for a new or existing offering or overall business venture leveraging the latest customer discovery and validation methods from Lean Innovation

Planning & Design

  • ​Product requirements and solution architecture definition
  • Mobile medical device realization per the FDA 510k and MDR processes based upon IEC 62304 / 82304
  • FDA / NIST CSF cybersecurity guidance and risk assessments (e.g. IEC 14971)
  • HHS HIPAA privacy, security and HITECH Act breach notification rulings and GDPR​
  • Serving an Innovation Architect to define detailed product / service and technology roadmaps
  • User experience design, human factors engineering and usability testing
  • Infrastructure vendor, device and OS platform realization strategies
  • Enterprise mobility solution definition around verticals
  • Detailed cost modeling and margin analysis
  • Business process re-engineering

Implementation & Launch

  • Serving in the critical 'Product Owner' role during the Agile development process (balance of daily voice of the customer inputs, technology realization and overcoming innovation inhibitors)
  • Supporting the rigors of design controls and quality management systems (e.g. IEC 13485)
  • Vendor analysis, RFP procurement, technology trials and contract negotiations
  • Product and application development planning (traditional and agile models)
  • In-network / enterprise and cloud / SaaS based implementations
  • Network operations and IT integration
  • Product / service packaging, labeling and branding
  • Market development and demand creation
  • Business / partner development, solution oriented selling and channel sales
  • Industry analyst, press and end-user outreach