Profile Details

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★★★★★

☆☆☆☆☆

USD 195 /hr

★★★★★

☆☆☆☆☆

Hire Manas K.

United States

USD 195 /hr

Consult/Interim/FT: Plan, Execute: Strat Mktg, NPI/NPD, Intl Biz - Device, Diag, IVD, POC, Tele, Wearable, Cybersecurity

Profile Summary

20+ years of planning, developing, executing, managing global strategic upstream marketing initiatives including developing roadmaps for portfolios of new products, platforms, and service solutions; and execution of competitively sustainable downstream tactics ... while at small to large multi-national companies. Expert Witness, Related to Legal Cases, and/or Govt Regulatory Areas: $395/hr for IVD/POC/Device regulatory compliance (FDA 510K, HIPAA, ISO, EU, MDR, Japanese, Chinese etc), competitive performance, functionalities of Medical Devices and Diagnostic Equipment and/or Software. Develop Plans, Reports/Dossiers, Presentations ($395/hr) for Corporate Vision, Mission, Strategies, Portfolio Roadmaps, Regulatory Path, Business Plans, Regulatory Submission. Plan, Develop, Lead ($295/hr) Cross-Functional Teams to build, execute and synthesize multi-country multi-segment VOC inputs, manage NPD phase-gate process-driven Upstream Global Strategic Business Plans with Roadmaps for Impactful P&L via Innovative, Integrated Portfolios of Regulated Medical Products and Service Solutions. Screen, Build, Train and Manage ($295/hr) high-performance US & Int'l Marketing, Distribution and Sales Teams to lead country-specific KOL Advisory Panel guided Downstream Initiatives for multi-segment commercial launch plans with incentive based realistic forecasts; "sticky", competitively sustainable, disease based market entry, brand awareness, education, adoption, share growth programs and promotions.... ...above includes any related, relevant tasks including distribution or field studies or assessments or market research, customer surveys I can perform in Brazil or adjacent countries in LATAM including in Mexico and Caribe or USA. Write, Edit, and Review: ($195/hr) C-suite presentations, marketing and sales collaterals including marcom / advertisements, User Guides, CRM / lead generation, pricing; qualitative and quantitative primary and secondary market research plans; Customer Requirements Document (CRD), Product Requirements Document (PRD) including Product Labeling, Marketing Requirements Document (MRD), Business Requirement Document (BRD) including NPV, P&L, ROI; Co-Marketing and Distribution Agreements, Contracts, Proposals; Grant Applications. - HIS, LIS, EMR, ICU, ER, Surgical Medical Devices; Core Lab Diagnostic Analyzers - IVDx, MDx, CDx; and Connected systems including for HIPPA / SOC2 Cybersecurity compliance; - Hospital, Ambulatory, Remote, Telehealth, Remote, Wearable critical care life support medical devices and integrated monitoring systems; - CLIA Waived equipment w/reagents, sensors and integrated, connected, wearable patient screening, diagnostic, remote monitoring and data-management systems for POC, POL, Clinic, Home use. - Multi-segment, multi-country, Professional, Capital, Reusable, Disposable, Private, Public, Govt sectors in US, CND, LATAM, EU, ME, APAC - Prices vary depending on type of project as shared above, are negotiable, can be hourly or project based, with discount potential for long-term or total hours committed, and do not include other costs for travel, hotel, tools, resources, sub-contracts etc. - I shuttle between Sao Paulo, Brazil, and Mountain View, CA, USA for my current freelancing projects - you can leave a voice-mail at my USA and/or Brazil mobile numbers, or send me an a/v link.

Subject Matter Expertise

• ☆ Information Technology
• ☆ Cybersecurity
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Medical Device Design
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ Medical Device Regulatory Consulting
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Lab-on-a-Chip Devices
• ☆ Health Technology Assessment
• ☆ E-Health & Telemedicine
• ☆ Home Health Care
• ☆ Medical Equipment & Supplies
• ☆ Product Compliance
• ☆ Concept Development
• ☆ Product Launch Support
• ☆ Packaging Design
• ☆ Software Development
• ☆ UX Design
• ☆ Presentation Design
• ☆ Graphic Design
• ☆ Regulatory Writing
• ☆ Nonclinical Study Documentation
• ☆ Medical Writing
• ☆ Healthcare Communications
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts
• ☆ Technical & Scientific Writing
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ Instructional Materials
• ☆ Release Notes
• ☆ Experimental Protocols
• ☆ White Papers
• ☆ Spec Sheets
• ☆ Case Studies
• ☆ Textbook Content Writing
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Copywriting
• ☆ Emails & Newsletters
• ☆ Marketing Copy
• ☆ Public Relations Writing
• ☆ Product Descriptions
• ☆ User Guides & Handbooks
• ☆ Proofreading & Editing
• ☆ Creative Writing
• ☆ News Writing
• ☆ Course Content Writing
• ☆ Grant Writing
• ☆ Business Operations
• ☆ Business Strategy
• ☆ International Business
• ☆ Small Business
• ☆ Entrepreneurship
• ☆ Cyber Investigation
• ☆ Branding
• ☆ Marketing Strategy
• ☆ Lead Generation
• ☆ Marketing Analytics
• ☆ Business Intelligence
• ☆ Innovation Management
• ☆ Project Management
• ☆ Management Consulting
• ☆ Advertising

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, General Proofreading & Editing

Research Market Research, User Research, Meta-Research, Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Gray Literature Search, Secondary Data Collection

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Product Evaluation, Product Validation, Product Compliance , Concept Development, Product Launch Support, Packaging Design, Prototyping

Work Experience

Sr. Strategic Commercial Advisor - Freelance

Tala Secure, Inc,, HMD Biomedical

January 2019 - Present

Sr Director Global Strategic Marketing and Business Development

Baebies, Abbott, Bayer, Quidel, Roche, BioTek Instruments

January 1984 - February 2019

Education

Continuing Education Courses, Certificates, Training: FDA 510K, MDR; NPD, CRM, Finance; CDx, MDx, Strategy

Stanford Univ, UC Berkeley, UCSC, Thunderbird

June 2011 - January 2015

MBA

University of California Irvine

June 2007 - December 2009

MS Bioengineering, MSEE

West Virginia University Morgantown, WV

August 1981 - December 1983

Certifications

• n/a

  n/a

  January 2024 - January 2024