About the Guest Lecturer
Dr. Manolo Ernesto Beelke (MD, PhD) is a physician, scientist, and Chief Medical Officer with over 28 years of experience in MedTech and pharma environments. He supports companies throughout the entire product lifecycle – from clinical product definition to successful market launch and adoption.
As the founder of Manolo Beelke & Partners and an external CMO, he helps organizations combine clinical evidence, regulatory requirements, HTA/HE&OR, and commercial objectives into a consistent overall strategy. His particular added value lies in reducing decision and implementation risks through an integrated Medical, Regulatory, and Commercial perspective.
Expertise & Experience
Areas of Expertise
  • Medical Affairs & Clinical Strategy
  • Clinical Evidence & Benefit-Risk Narratives
  • MDR / IVDR & FDA (510(k), PMA)
  • Clinical Evaluation (CEP / CER), PMS & PMCF
  • Risk & Quality Management (ISO 14971)
  • Design Control & Design History File (DHF)
  • HE&OR & Market Access
  • Medical–Sales–Alignment & Compliant Communication
  • Vendor‑, CRO‑ & CDMO‑Oversight
  • Governance, CAPA, Audits & SOP Systems
Roles (Selection)
  • Manolo Beelke & Partners – Owner & Managing Director
  • Verum.de – Chief Medical Officer
  • AND Biotech – Chief Medical Officer
  • AgoneX Biopharmaceuticals – Chief Medical Officer
  • Immunogenetics – Chief Medical Officer
Selected Scope and Deliveries
  • Global Phase I–III medical lead (CNS, rare disease)
  • Pivotal design and trial rescue. Decision rules and governance
  • Claims-to-evidence strategy. CER, PMS/PMCF, authorities
  • Audit-ready operating model. Oversight and vendor governance
  • Clinical supply interface oversight. IMP logistics risk control
  • Access-ready value narrative. Medical, regulatory, HE&OR, commercial aligned
The Elective Course
Title
Medical Affairs for MedTech Sales: Evidence-to-Adoption, Stakeholder Logic, and Compliance-Safe Selling
Brief Description
This elective course demonstrates how Medical Affairs measurably improves sales performance. The focus is on the path from clinical evidence to adoption: Which data convinces which stakeholders, how product features are translated into robust benefit arguments – and what are the regulatory and compliance limits.
Participants learn how Medical and Sales work as a coordinated system: evidence-based, compliant, and customer-relevant. Practical decision-making logics in hospitals, tender processes, objections, and response standards are covered – with the goal of shortening sales cycles, building trust, and minimizing risks.
Reduce risk. Increase credibility. Improve adoption.
What you will learn
After the elective, participants will be able to:
  • Purposefully apply clinical evidence in sales situations
  • Understand decision-making logic of users, chief physicians, procurement, Quality Managment IT & data protection
  • Create a Claims & Evidence Map (Statement – Evidence Level – Limits – Permissible Formulation)
  • Select appropriate evidence formats (studies, RWE, registries, PMS/PMCF)
  • Address typical objections in a structured and compliant manner: "Too little evidence", "No workflow fit", "Risk / Liability", "Too expensive / no budget", "Tender / alternatives available"
  • Develop a Response Playbook for Sales (Do's & Don'ts, escalation to Medical)
  • Establish consistent Medical-Sales governance
Practical added value: Participants will leave the elective with immediately applicable tools to sustainably increase adoption, closing probability, and trust level.
Format & Dates
Format & Duration
Online, 3 hours
Target Audience
  • Sales & Business Development Profiles
  • Key Account Managers (OEM / Pharma / CDMO)
  • Product Managers & Product Owners
  • Project & Program Managers (MedTech / CDMO / OEM)
  • Quality & Regulatory Managers with interface functions
  • MedTech & CDMO Generalists
Didactic Approach
  • Case-based & delivery-oriented
  • Practical examples from MedTech and Pharma programs
  • Development of a Claims/Evidence Map and a Sales Response Playbook
  • Content sales-optimized, but also applicable for RA/QA/PM
  • Clear demarcation from impermissible promotion
Language: German or English | Cost: TBD
This elective is ideal for sales and BD professionals, and anyone who wants to see Medical Affairs as an enabler, not a constraint.
Contact & Registration:
Sales Academy MedTech
Amir Tahric
📞 +41 79 456 72 28
✉️[email protected]