gms | German Medical Science

Classification systems play a critical role in the early stages of medical device development, helping to streamline the process and ensure that all stakeholders are on the same page. However, there is a need for a unified classification system for the description of MedTech prior to their regulation. Different systems and organisations are currently using varying terminologies, leading to difficulties in achieving a unified understanding. This poses a barrier to early identification of these technologies ahead of being placed on the market. Furthermore, a number of different stakeholders participate in the technology’s development pipeline which may use different classifications made to fulfil their own purposes but not widely recognised or used by others. Many classification schemes exist but as the technology evolves through their development pathway their characteristics change and often this leads to some classification codes becoming inaccurate or redundant or unable to represent the evolutionary nature of the technologies.

This workshop aims to engage the audience in an interactive discussion about the current situation and present different proposed pathways to mitigate this problem. The audience will be a full participant and contribute with their expertise in MedTech development pathways, classification system development or other knowledge and expertise relevant to this workshop.

Who should attend:

MedTech manufacturers, Software developers, regulators, healthcare providers, nomenclature developers and academic professionals, standard bodies representatives, public body representatives.

Agenda/Outline of the workshop

Learning Objectives

Introduction of the problem:

1.

The challenge of having different classification systems when there is a need to provide a holistic view of a technology through its entire development, from ideation to market adoption.

2.

List some of the barriers that a lack of a holistic classification system pose:

• Retrieval and identification
• Duplication of effort
• Difficulty identifying technology development pathway
• Regulatory evaluation
• Technology Assessment
• Naming irregularities
• Data integration from various sources
• Interoperability

Presentation of the potential solutions with challenges: ScanMedTech a knowledge graph developed by the Innovation Observatory for the identification of weak signals of MedTech innovation that uses a holistic classification system.

Interactive components: Voting on proposed solutions via Mentimeter.com with prizes for the quickest ‘voter’ – this interaction may be embedded throughout the entire presentation.

Breakout into small groups to work on specific tasks and collecting feedback afterwards from each group. This feedback may be considered as part of the IO solution and approach to solve this problem and could potentially be published.

Invited speaker guest Hans-Peter Dauben from i-HTS.org to contribute with their perspective on this topic.