What strategies are required to develop products that help patients? Patients are a group of customers, who do not tend to have any purchasing power. Regulatory hurdles, economic pressures and an industry reliant on archaic SOPs are some of the challenges when developing products for patients. In this webinar, Venkat Venkatakrishnan will focus not only on product development methodologies, but also on strategies to navigate legal and regulatory hurdles, geographical challenges and prioritization frameworks.
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Webinar Notes:
- Venkat, with 15 years of healthcare product development experience, discusses strategies for developing healthcare products.
- Understanding diverse healthcare stakeholders—practitioners, patients, caregivers, regulators—is crucial in product development.
- Healthcare product categories include medical devices, pharmaceuticals, digital health, wearables, analytics, and more.
- Differentiating between regulated and non-regulated products is essential; digital health startups are on the rise.
- Laws governing healthcare data necessitate expert review of data use and architecture; GDPR and global laws add complexity.
- Verification and validation in healthcare akin to drug clinical trials—focus on correct usage, harm prevention, and risk management.
- User testing and validation is vital; the unique nature of healthcare products requires tailored approaches.
- Apple, Amazon, Google faced challenges during healthcare product launches; customer trust takes time due to sensitive nature.
- Beyond engineers, staff training is crucial—customer service, HR, legal—addressing HIPAA, FTC, GDPR regulations.
- Challenges in healthcare product development include AI disruption, global-local complexities, maintenance costs.
- AI and ML are revolutionizing personalized medicine; AI’s diagnostic abilities lead to regulatory questions.
- Global launch strategy is critical; consider regulations, languages, customer needs, infrastructure, and legal advice.
- Challenges covered include data laws, verification, validation, user testing, staff training, and regulatory complexities.
- Venkat highlights building trust, legal reviews, regulatory compliance, stakeholder management, and data protection.
- Handle protected health information (PHI) and personally identifiable information (PII) with utmost care.
- Rigorous regulatory landscape underscores the need for proactive legal and regulatory reviews.
- Balancing customer needs, regulations, stakeholders, and legal aspects is key in healthcare product development.
About the speaker
Product Owner and Strategic leader with 13 years’ experience in software development, product development, regulatory compliance and program management. 9+ years managing globally distributed teams with a mix of analysts, product owners, R&D leaders and vendor partners. Generalist by choice, adept at integrating biology, technology, and business. Strong track record of delivering solutions and products that empower users with easy data access, statistical rigor, actionable intelligence & predictive capabilities. Core Competencies ● Data driven product development ● Voice of Customer, Focus group & Survey analysis ● Failure Analysis and Risk Management ● UI/UX and user journey development (Miro, Figma) ● SDLC and AGILE Planning; R, Python, Tableau ● Budget and Resource Management, MS Project ● Statistical Analysis (Six Sigma Green Belt) ● Design thinking and feature road mapping ● Business Development & Account Management ● Regulatory expert (ISO, CE, FDA, MHRA, EU-MDR)