6th EMWA Symposium
Medical Devices and Technologies - Emerging Opportunities for Medical Communicators
Thursday 3 May 2018
The 6th EMWA symposium day, with focus on medical devices and the recent changes in the European legislations, is targeting regulatory writers and medical communicators alike. It provides the perspectives of different stakeholders, including medical writers, legislators, notified bodies, medical device companies, patient representatives, and reimbursement professionals.
The following topics will be discussed:
- Introduction to medical devices
- Transferable skills: From drugs to medical devices
- The new Medical Device Regulation (MDR) and its implications for medical writers
- MDR and MEDDEV: what notified bodies are looking for in clinical evaluation reports (CERs)
- Patients as users: Apps, technologies, security, and potential failures
- Databases and tools: systematic reviews
- From bench to publication: all you need to know about medical devices based on a case example
- Publication planning during the life cycle of a medical device
- European medical devices reimbursement strategies and associated documents
ContentThe field of medical devices is a broad one: wheelchairs, contact lenses, X-ray machines and implantable cardioverter defibrillators are all medical devices, but they have completely different uses and pose different risks to the patient, the user and the environment. Thus, medical devices are classified based on their risk profile, affecting the processes required for their market release. Medical writers play a key role in this process: they write some of the most important documents required for market approval such as the clinical evaluation report, clinical investigational plan and clinical investigation report. This introductory session gives an overview of the terminology used, the classification system, the regulatory pathways and the role of medical writers in preparing the documents required.
ContentThe idea of writing about medical devices might seem daunting - after all there are so many of them ranging from the simplest wound dressing to the most sophisticated imaging equipment. However, typical ‘pharmaceutical’ documents such as clinical study protocols, clinical overviews and summaries, and summaries of product characteristics have their equivalents for medical devices. Just as ‘pharmaceutical’ writing is governed by guidelines and directives, the same is true for medical devices. Similar skills are needed for pharmaceutical and medical device writing, namely the ability to follow guidelines, use templates, evaluate medical literature and write clearly and objectively. So a writer accustomed to writing about pharmaceuticals may discover that they can just as easily write about medical devices.
ContentIn May 2017, two new regulations were published namely Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, foreseen to enter into application 26 May 2020 and 26 May 2022 respectively. The presentation will start by outlining the key new features of these regulations with a focus on the clinical/performance aspects, which represent one of the major overhauls of the legislative framework for medical devices. This section will be supplemented with an outline of implementation priorities as well as the transitional timelines and measures. An overview of the existing guidance will follow along with plans for its updating in order to bring it in line with the requirements of the new regulations. The core of the presentation will cover sections on the clinical/performance requirements relevant to medical writers along with the latest novelties brought about by the activities of the Clinical Investigation and Evaluation Working Group. This will include information regarding the development of guidance on the Summary of Safety and Clinical Performance, various templates, an addendum to MEDDEV 2.7/1 rev 4 and EUDAMED as the future database for medical devices. The importance of scientifically sound and well written clinical sections of the medical devices technical files and the role of medical writers will be covered at the end.
ContentThe clinical evaluation is an essential part of the technical documentation, which manufacturers are required to use to document their compliance with the general safety and performance requirements. The new medical Device Regulations places greater emphasis on the use of clinical data to demonstrate compliance with the general safety and performance requirements. With the increased scrutiny expected with the new regulations, the guidance document, MEDDEV 2.7.1 (rev 4) was published in July 2016, to prepare manufacturers and notified bodies on key requirements for clinical evaluation. Although compliance with Revision 4 of the MEDDEV does not mean compliance with the new regulations, it brings manufacturers relatively close to compliance. This presentation focuses on the key requirements, and what notified bodies will be looking for when reviewing clinical evaluation reports. And by understanding what the notified will be looking for, clinical evaluation reports may be better written and presented for assessment.
ContentThousands of health apps are available today, often using different approaches for different audiences. They range from fitness/nutrition trackers to apps connected with existing medical devices such as blood monitors and complex medication infusion systems. Using diabetes as an example across chronic disease, this talk will propose a framework to think about apps, potential classification categories, and important differences such as primary use cases, medical content/nature, as well as software development infrastructure. Furthermore (a) the impact of apps on patients, health care professionals, and other healthcare stakeholders (b) the potential role of apps in our health systems and (c) current limitations and progress (including clinical evidence, data ownership and safety) will be discussed.
ContentFinding the right information for Medical Device Clinical Evaluations and Post-Market Surveillance for biomedical searching
Information found in the biomedical literature strengthens every stage of the medical device life cycle, from concept and design through clinical trials to commercial release and reimbursement, as well as post-market surveillance.
Embase provides all the relevant information and essential evidence for creating high-quality systematic reviews that support medical device development and post-market surveillance. In this session, Senior Product Development Manager Embase Dr Ivan Krstic will talk about:
- European Medical Device Clinical Evaluation Report guidelines (MEDDEV 2.7/1)
- The importance of biomedical literature in preparing successful Clinical Evaluations and in remaining compliant with post-market surveillance requirements
- Case Study: How to design effective literature searches for CER to identify:
o Device clinical performance
o Comparison of device with existing device(s)
o Device safety – finding adverse device effects
ContentThis presentation will build on the previous presentations and show the complete life-cycle of a medical device based on the practical example of a novel scaffold technology. It includes possible pitfalls, setbacks, and considerations in data interpretation. The aim is to provide a robust overview of the device development that will facilitate understanding clinical data obtained from medical device studies.
ContentWith the current changes in the medical device industry, with new regulations and move from a traditional customer base of health care professionals to health care administrators, it is more important than ever to have peer-reviewed clinical evidence and to tell a “story” of a medical device throughout its lifecycle.
The session will discuss the variety of studies worthwhile to publish (from pre-clinical animal models to post-approval studies), the regulatory context of publications, how to create an evidence based strategy throughout the lifecycle of the product, possible challenges, and will provide an example of an effective publication strategy.
ContentMarket access is extremely important for the success of innovative technologies. It includes obtaining reimbursement (ability to pay for procedure/device) and funding (willingness to pay). To establish reimbursement and funding, multiple activities might be needed, including application for procedure code and change of the Diagnosis-Related Group (DRG) system, applications for reimbursement review, and health technology assessment. In this presentation, one of the leading European market access experts, Oleg Borisenko, will outline some of the specifics of the market access processes and how medical writers can contribute to these processes. In particular, the following questions will be addressed:
· What are the typical reimbursement barriers for medical devices in Europe?
· What are the typical requirements to overcome reimbursement barriers?
· What can be a role for a medical writer to support reimbursement activities?
· What is the concept of the value dossier?