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MedTech Strategy Xchange - San Francisco 2025

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Welcome to hubXchange's MedTech Strategy Xchange San Francisco 2025.

This event brings together senior-level scientists and executives from the pharmaceutical and biotech sectors to tackle key challenges in Regulatory Strategy, Clinical Validation & Trial Design, Product Development & Device Engineering, Supply Chain and Scalable Manufacturing.

Attendees can engage in roundtable discussions, pre-booked 1:1 meetings, presentations, and networking sessions with top industry experts, to foster collaboration and find innovative solutions to accelerate HealthTech.

Take advantage of this unique highly interactive meeting format designed for maximum engagement, collaboration and networking.

San Francisco | Tuesday 23th Sept 2025 | 08:00am - 06:20pm

VIEW AGENDA    REGISTER FOR FREE    OUR PARTNERS    EVENT INFORMATION

Why choose hubXchange?


 

 

FULL AGENDA

Click the topic titles to find out more!

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08:00
  1. Registration
    30 mins
    • Regulatory Strategy
    • Clinical Validation & Trial Design
    • Product Development & Device Engineering
    • Supply Chain
    • Scalable Manufacturing
08:30
  1. Opening Address & Keynote Presentation:
    30 mins
    • Regulatory Strategy
    • Clinical Validation & Trial Design
    • Product Development & Device Engineering
    • Supply Chain
    • Scalable Manufacturing
09:05
  1. Regulatory Strategy
    How early should regulatory teams be involved in product development to influence critical design decisions
    60 mins
    • Regulatory Strategy
  2. Clinical Validation & Trial Design
    Bridging the gap between device innovation and behavioral health clinical trial design
    60 mins
    • Clinical Validation & Trial Design
    Annika Lundström
    Annika Lundström, Chief Executive Officer - ReMinded
  3. Product Development & Device Engineering
    At what stage do you integrate human factors into the product development process?
    60 mins
    • Product Development & Device Engineering
    Liz Eaton
    Liz Eaton, Director New Product Development R&D - Johnson and Johnson
  4. Supply Chain
    How can companies ensure that the engineering design is adaptable to mass production without incurring high rework costs?
    60 mins
    • Supply Chain
  5. Scalable Manufacturing
    How can early-stage design decisions impact the scalability of a medical device?
    60 mins
    • Scalable Manufacturing
10:10
  1. 1-2-1 Meetings / Networking Break
    30 mins
    • Regulatory Strategy
    • Clinical Validation & Trial Design
    • Product Development & Device Engineering
    • Supply Chain
    • Scalable Manufacturing
10:40
  1. 1-2-1 Meetings / Networking Break
    30 mins
    • Regulatory Strategy
    • Clinical Validation & Trial Design
    • Product Development & Device Engineering
    • Supply Chain
    • Scalable Manufacturing
11:10
  1. Morning Refreshments
    10 mins
    • Regulatory Strategy
    • Clinical Validation & Trial Design
    • Product Development & Device Engineering
    • Supply Chain
    • Scalable Manufacturing
11:20
  1. Regulatory Strategy
    What internal strategies or team structures help manage multi-region regulatory submissions efficiently?
    60 mins
    • Regulatory Strategy
  2. Clinical Validation & Trial Design
    What are practical approaches to conducting post-market clinical follow-up (PMCF) when pre-market trials are limited?
    60 mins
    • Clinical Validation & Trial Design
  3. Product Development & Device Engineering
    How do you ensure traceability and documentation remain compliant under accelerated timelines?
    60 mins
    • Product Development & Device Engineering
  4. Supply Chain
    What are the best practices for forecasting demand and managing inventory for high-demand devices?
    60 mins
    • Supply Chain
  5. Scalable Manufacturing
    How can digital twin technology enhance predictive maintenance and reduce downtime in manufacturing lines?
    60 mins
    • Scalable Manufacturing
12:20
  1. Networking Lunch
    60 mins
    • Regulatory Strategy
    • Clinical Validation & Trial Design
    • Product Development & Device Engineering
    • Supply Chain
    • Scalable Manufacturing
13:25
  1. Spotlight Presentation:
    30 mins
    • Regulatory Strategy
    • Clinical Validation & Trial Design
    • Product Development & Device Engineering
    • Supply Chain
    • Scalable Manufacturing
14:00
  1. 1-2-1 Meetings / Networking Break
    30 mins
    • Regulatory Strategy
    • Clinical Validation & Trial Design
    • Product Development & Device Engineering
    • Supply Chain
    • Scalable Manufacturing
14:35
  1. 1-2-1 Meetings / Networking Break
    30 mins
    • Regulatory Strategy
    • Clinical Validation & Trial Design
    • Product Development & Device Engineering
    • Supply Chain
    • Scalable Manufacturing
15:10
  1. Spotlight Presentation:
    30 mins
    • Regulatory Strategy
    • Clinical Validation & Trial Design
    • Product Development & Device Engineering
    • Supply Chain
    • Scalable Manufacturing
15:40
  1. Afternoon Refreshments
    10 mins
    • Regulatory Strategy
    • Clinical Validation & Trial Design
    • Product Development & Device Engineering
    • Supply Chain
    • Scalable Manufacturing
15:50
  1. Product Development & Device Engineering
    Poster Presentation: What role do supply chain constraints play in material or component decisions during early design phases?
    30 mins
    • Product Development & Device Engineering
  2. Regulatory Strategy
    Poster Presentation: What systems do you use to ensure real-time reporting of adverse events and timely corrective actions in compliance with global standards?
    30 mins
    • Regulatory Strategy
  3. Clinical Validation & Trial Design
    Poster Presentation: How early should market access teams be engaged during trial planning?
    30 mins
    • Clinical Validation & Trial Design
  4. Supply Chain
    Poster Presentation: What tools or techniques are best for validating process controls, especially for complex or highly regulated devices?
    30 mins
    • Supply Chain
  5. Scalable Manufacturing
    Poster Presentation: How can manufacturers maintain regulatory compliance when transitioning from small-batch to high-volume production?
    30 mins
    • Scalable Manufacturing
16:20
  1. Regulatory Strategy
    How do you identify and manage potential compliance risks during product lifecycle management, from concept to post-launch?
    60 mins
    • Regulatory Strategy
  2. Clinical Validation & Trial Design
    How do you define appropriate clinical endpoints that balance regulatory, clinical, and market expectations?
    60 mins
    • Clinical Validation & Trial Design
  3. Product Development & Device Engineering
    What are other sterilizations methods that can be used to lieu off in lean
    60 mins
    • Product Development & Device Engineering
    Sanjay Sri
    Sanjay Sri, Principal Quality Engineer - Nevro
  4. Supply Chain
    How do you balance the pressure to reduce costs with the growing need for environmentally responsible practices in device manufacturing?
    60 mins
    • Supply Chain
  5. Scalable Manufacturing
    How do rapid prototyping and iterative testing support scalable development?
    60 mins
    • Scalable Manufacturing
17:20
  1. Drinks-Canape Reception
    60 mins
    • Regulatory Strategy
    • Clinical Validation & Trial Design
    • Product Development & Device Engineering
    • Supply Chain
    • Scalable Manufacturing

EVENT INFORMATION

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DATES

San Francisco
Sept 23, 2025

Tuesday 23rd September 2025

 

DoubleTree by Hilton San Francisco Airport Hotel Photo

VENUE

DoubleTree by Hilton San Francisco Airport Hotel

DoubleTree by Hilton
San Francisco Airport Hotel
835 Airport Blvd, Burlingame
California, 94010-9949

MAP

EVENT PARTNERS

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