The new Medical Device and HTA Regulations in the EU bring significant changes to the industry, requiring companies to adapt to new standards for clinical evidence generation and centralized assessments at the EU level.

These shifts, alongside rapid digitalization and technological advancements, demand that companies modernize, restructure, and acquire new managerial skills to remain competitive.

The “Value-Based Medtech” course aims to address these system and industry changes, providing insights on how to navigate and succeed in this evolving landscape. It covers the consequences of the new EU Regulations on the medtech ecosystem, current and future trajectories of the HTA of medical devices, evidence generation, evaluation processes and methods, ongoing trends in procurement approaches, and innovative reimbursement policies.

To gain a comprehensive understanding of the context and key challenges in the medical device sector, including the impact of ongoing changes in international regulatory science for technological advancement in healthcare, the lifecycle evidence generation and assessment for medical devices, the evolving role and scope of HTA, and innovative health policies such as value-based procurement and pricing.

It Fits You If

You are a professional or part of a company looking to transform the current changes in the medical device sector into growth opportunities. This course is particularly suited for health-tech developers, manufacturers, payers, policymakers, patient associations, and scientific societies.

We recommend having at least a few years of professional experience.

Program Counseling

Olesea Ciumas
Program Advisor

Contact our Program Advisor for more detailed information about the program or to build a customized plan or you or your organization.

Write to: olesea.ciumas@sdabocconi.it

Structure and Contents

3 days

24 equivalent hours

1 pillar

Pillar I

Key challenges of the medical device sector

Lectures

Business Case

Simulations

Testimonials

Download the brochure to find out more about the program and the Faculty of the course..

Download Brochure

Program Agenda

Aula

13 - 15 Oct 2025

9:00 - 18:00

MODULE
in presence

Locations

SDA Bocconi School of Management
Via Sarfatti 10, 20136 Milano

Fee

€ 3.500 + IVA
The fee is exclusive of VAT and includes course materials and working breakfasts.

Special Payment Terms

Bocconi Alumni

Bocconi Alumni are entitled to a 10% reduction on participation fees. To take advantage of the discount, please enter your Alumnus status when registering by indicating“ALUMNI10” in the notes section. Remember that without this indication, the discount will not be applicable.
Women are good for business

The educational dimension is one of the tangible levers that we can provide to men, women, and our organizations to truly make a difference, to have an impact. Providing education means offering a concrete tool for change and social transformation. To foster and contribute to women’s professional development, SDA Bocconi School of Management offers them until 8 March 2026: a 20% discount on the participation fee for all Executive Open Programs and Executive Online Programs.
Multiple enrollments

Companies, institutions and public bodies that enroll at least 3 participants in a single program are granted a 20 percent discount for each registration fee. The concession is not applicable for personal enrollment and must be formalized by the start date of the course.

Early Bird

A 10% reduction on the program fees offered to applications sent in by 13th August 2025.
Custom training programs

In the case of training needs involving several resources of the same company enrolled in more than one program, it is possible to define a customized plan from the specific needs of the organization. In this case, our Program Advisors are available to build with the client organizations ad hoc training plans with special pricing.
Partnerships and channel agreements

SDA Bocconi offers the possibility to initiate collaborations that allow them to expand the portfolio of educational trainings to be offered to their members. In this case, the School is available to evaluate partnerships and channel agreements so as to respond in a timely manner to the specific needs of the organization.

By attending at least 80% of the classes, you will receive a certificate of participation in the program and a digital badge to share with your network on LinkedIn.

Program Direction

“New regulatory frameworks, changing competitive environment and evolving health needs: these are some of the most compelling challenges that stakeholders in the medical-device sector have to face. The course will explore the conditions and tools that can make the difference for succeeding in a rapidly evolving environment, bringing together solid experience in the sector both from the faculty and from international key opinion leaders.”

Go to CV

Rosanna Tarricone

Director

“The medical-device sector is experiencing continuous and rapid development. Keeping pace with advances in this complex ecosystem is essential to fostering innovation and, ultimately, improving patients’ health. The course will tackle the most urgent issues in this ever-changing environment, and will be an opportunity to share points of view and hands-on experience in an international context.”

Go to CV

Ludovica Borsoi

Director

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Take Action

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Value-Based Medtech: How To Succeed In a Challenging Environment

Adapting to New Medical Device and Hta Regulations