Value-based Medtech: How to Succeed in a Challenging Environment

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Start date Oct 14, 2024
End date Oct 16, 2024
Duration 3 Days
Location Milano
Format Class
Language English
Price (+ VAT) €3,500


The enforcement of the new Medical Device and HTA Regulations represents a disruptive change for the industry. On the one hand, companies will be asked to deal with new standards for generating clinical evidence and with the fact that assessments will no longer be the responsibility of each country, but rather centralized at the EU level. On the other, digitalization and the use of new technologies are increasingly advanced, and are unpredictably changing the medtech landscape. To confront these challenges and remain competitive, companies must modernize, radically overhaul their organizational structure and acquire new managerial skills.

The course Value-Based Medtech aims to discuss the drivers of changes and how to successfully respond to new challenges to keep competing in an unstable, unpredictable future. What are the immediate consequences of the new European Regulations? How is the HTA of medical devices evolving in Europe? Does it incorporate environmental impact? What evidence needs to be generated? How, when and by whom should it be evaluated? Will digital technologies (mHealth) be evaluated with the same methods and processes as medical devices? Will the methods of purchasing medical devices change (innovation procurement)? Will reimbursement policies include innovative formulas such as bundled payment? These are some of the questions you will answer by attending the course

Who is it for

This course is for professionals and companies who wish to transform the current context of change into opportunities for growth and development. More specifically, the course is open to health-tech developers and manufacturers, end users, payers, policymakers, patient associations and scientific societies. In order to fully profit from the course, it is advisable to have at least few years of work experience.

Program Counseling

To help you decide whether the contents of the course will meet your expectations and choose the best education options for your profile and objectives, you can contact one of the course’s Program Advisor to discuss the details.
Contact Patrizia 

Structure  & Topis Covered

This 3-day program (24 equivalent hours) consists of 4 modules, during which participants will delve into the following topics:


1. The Context

  • What is the immediate impact on stakeholders of the New EU Regulations on medical devices?
  • Evolution of HTA of medical devices in Europe and new frontiers in impact evaluation (e.g., environmental sustainability)
  • Value-based healthcare and value measurement:
    • The role of patients and patient-reported outcomes
    • The role of real-world data and real-world evidence for comparative assessment analysis

2. Evidence Generation and Evaluation

  • Challenges in evidence generation for medical devices:
    • From pre and post-market to lifecycle generation of clinical and economic evidence
  • Are mHealth and medical devices “one size fits all” in terms of regulation and HTA processes?
    • Challenges in regulation and evaluation of digital health technologies
    • Methods for assessing patient-reported outcomes for digital health technologies
    • Case study on mHealth

3. Anticipating the "Business Case"

  • Opportunities for early dialogue and early HTA
  • New study design: early feasibility studies
  • Accelerated Access Program in Europe: is it feasible? 

4. Frontier Health Policies to Manage Innovation

  • Innovation procurement
  • Bundled payments
  • Value-based pricing
  • EU vs US: a comparison of different contexts


Download the brochure to find out more about the expected learning outcomesthe learning model and the Faculty of the course.

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Why Join Us?

Cosa trovi nel programma

Advantages for Participants

  • Expand your knowledge of the medical device sector by tackling the most urgent topics in the policy agenda
  • Understand in detail the changes connected to the new Medical Device and HTA Regulations to successfully cope with the current and emerging challenges in this sector
  • Get new inputs from an experienced faculty and peers with heterogeneous background and expertise, as well as from key European and US opinion leaders

Advantages fot the Company

  • Enhance your employees’ ability to understand a complex and rapidly evolving industry and find the most appropriate solutions to effectively manage the introduction and dissemination of innovation
  • Offer your employees the opportunity to discuss the hot topics and most impelling challenges of the medical-device sector in a highly interactive and international environment
  • Foster a multidisciplinary debate on future evolution trajectories of the sector in order to anticipate the “business case”


Digital Badges

The digital badges are an innovative and immediate way to share your achievements. They are verifiable and associated with an individual user. They allow you to update your network of contacts by highlighting the different steps reached in your SDA Bocconi journey.


Certificate of Partecipation

The certificate – presented in both print and digital forms – is a useful way to enhance your CV and portfolio of educational experiences. It is granted to participants who have attended at least 80%.



The program lasts 3 days (24 hours total equivalent).


14 - 16 Oct 2024

9 am - 6 pm

    in Presenza


Program Location

On-campus training will take place at:
SDA Bocconi School of Management,
Via Sarfatti 10, 20136 Milan (Italy)


€ 3.500 (+ VAT) fee includes educational materials and working lunches, but not VAT.

Special Payment Terms

For further information and details on discounts, please refer to:

Early Bird

A 10% reduction on the program feeis offered to applications sent in by 14th of August 2024.

Apply ASAP

You can apply for the Program until the day before it is due to start. For organizational reasons, we encourage you to complete your registration process 10 days before the Program begins.

“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.”


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Rosanna Tarricone

“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.”


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Ludovica Borsoi
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