Launching medical devices and associated software: an integrated approach?

Patenting, regulatory aspects and reimbursement

This one day program has been specially designed to offer an integrated approach for successfully launching medical devices and associated software.
This seminar is organised by Leuven.Inc, in co-operation with K.U.Leuven Research & Development and LMTC (Leuven Medical Technolgy Center)

Bringing medical devices/software to the market requires a thorough understanding of the regulatory requirements and process and if you have an innovative technology, reimbursement systems need to be controlled. Furthermore, patent protection is often an absolute must for medical devices as they can give the medical device a period of exclusivity which justifies the costly and R&D intensive development of the device.

The speakers will introduce you to the current status and practitioner insights in patenting, regulatory aspects and reimbursement of medical devices and associated software. Each topic will be illustrated with a company case study.

Who should attend?
- Industrial and academic researchers in biomedical engineering
- Business development, licensing, technology assessment, external collaboration, legal and alliance managers
- Executives and members of the investment community involved in value driven medical devices projects
- All interested professionals who want to improve and broaden their knowledge on patent protection, regulatory aspects and reimbursement

Date and location
Date: Tuesday May 12, 2009
Location: Faculty Club, Zaal Lemaire, Groot Begijnhof 14, 3000 Leuven

- 09u30: Registration and coffee
- 10u00: Welcome and introduction
What do we understand by a medical device and an associated software?
* Jos Vander Sloten (Prof. Biomechanics and Engineering Design, K.U.Leuven)
- 10u15: Medical devices: Intellectual Property Rights
The development of high technology medical devices is very costly and R&D intensive. Often patent protection is an absolute must for medical devices as they can give the medical device a period of exclusivity which justifies the large investment.
* William E. Bird (Partner, Bird Goën & Co)
* Philippe Lahorte (Patent Examiner, European Patent Office)
- 11u30 Case: <B< SME an business: your benefit strategies patent can>
* Koenraad Van Schuylenbergh (R&D Director, 3WIN )
- 12u00: Questions and answers
- 12u30: Sandwich lunch
- 13u30: Medical devices: Regulatory Aspects during product development and patients rights issues
Medical devices are subject to regulatory requirements. Too often we try to commercialise (patented) medical devices/software without taking the impact of the regulatory process into account. It is, however, a crucial element that should be taken into account in a very early stage of development.
A special focus will also be given to the aspect of how we should deal with the rights of a patient within the development of a medical device. When is informed consent needed?
* Philippe Bauwin (former Coordinator Federal Agency for Drugs and health products
AFMPS/FAGG, Medical Devices Dept)
- 14u20:Cases
Medtronic Bakken Research Center: Innovation of and through active implantable medical devices
* Hans van Dulmen (Senior Regulatory Consultant)
Materialise: Integration of regulatory aspects in the medical software process
* Sabine Demey (Director Software Development Materialise & Department Manager CMF)
- 15u10: Coffee/tea break
- 15u35: Medical Devices: Reimbursement issues
The question whether the medical device will benefit from reimbursement by the national health authorities will determine the success of the medical device in the market.
* Eva D'Haese (Dr.Apt, RIZIV)
- 16u20 Case: Key success factors for commercialisation
* Robin Maisonneuve (Project Manager, Johnson & Johnson DePuy France SAS)
- 16u50: Final conclusions
- 17u00 Drink

William E. Bird
, Partner Bird Goën & Co
Philippe Lahorte, Patent Examiner, European Patent Office
Medical devices: Intellectual Property Rights

The generation, protection and exploitation of innovation results is becoming increasingly important to create and maintain a competitive advantage in industry and academia alike. In this context, patents often play a crucial role in the medical technology field. What are the key points and main procedures to observe when engaging in patenting of medical devices? What can be patented? How long will it take to get a patent and what will it cost? USA versus Europe: what are the main differences? This lecture should give participants an increased understanding of both procedural and substantial patenting issues thereby enabling them to optimize their patent drafting, interaction with professional representatives and patent examiners, as well as patent prosecution strategy.

Koenraad Van Schuylenbergh, R&D director 3WIN
How can patent strategies benefit your business

In this talk Koenraad Van Schuylenbergh will share a personal look at IP and patenting from the perspective of a small biotech company. Its limited legal clout and the shear number of patent claims out there are rather daunting for the SME fully absorbed in getting its product to market. Notwithstanding, a carefully crafted patent portfolio remains a vital tool in creating business value for your technology SME.

Philippe Bauwin, former coordinator AFMPS/FAGG, Medical devices department
Medical devices: regulatory aspects / patients rights issues

- european directives and transposition in Belgian legislation
- present situation: software associated with medical devices
- principles, essential requirements, reference documents, development and clinical evaluation, notification of incidents
- new perspectives with the revision of the medical devices : self standing software as a medical device

Hans van Dulmen, Senior Regulatory Consultant, Medtronic Bakken Research Center
Innovation of and through active implantable medical devices

Active implantable medical devices such as pacemakers and defibrillators are most strictly controlled in various regulatory environments. Unexpected failure of these devices may have immediate serious consequences for the patient. Therefore, bringing such devices to the market is only allowed if the manufacturer can demonstrate that essential requirements for safety and performance are met. Because innovation in medical devices is typically a process of many consecutive small steps, a new generation device shows often more similarities than differences compared to its predecessor. This gradual innovation process reduces risk for patients as well as for manufacturers. Evidence of performance may be based on a clinical study performed with the new device or on data from the medical literature. One interesting approach to limit the risks associated with innovation is the use of investigational software that can be downloaded into an already implanted device for the purpose of investigating the clinical performance of new features.

Sabine Demey, Director Software Development, Materialise
Integration of regulatory aspects in the medical software development process

Medical devices, including medical software, are subject to regulatory requirements. Materialise recognizes that it is important to integrate the regulatory requirements in the process. All people involved in the development process should be aware of these requirements and take them into account in their daily operations. Regulatory aspects cannot be handled in a separate process by quality managers from a separate quality department. Important aspects are the integration of risk management from the phase of the first ideas to post-sales, the involvement of the regulatory affairs manager in design reviews to ensure a timely registration of medical devices that does not postpone the marketing of the device, careful documentation of all executed steps in the process.

Eva D'Haese, Dr.Apt RIZIV
Medical devices: reimbursement issues

The legislation concerning the reimbursement of medical devices is on the verge of changing. In May 2009 the first step of a new legislation, the notification of implantable medical devices, will be operational. The new legislation also includes a new application procedure. This procedure will probably come into effect on May 1st 2010. This new procedure will be the focus of the presentation. The current situation will be discussed briefly. The two main differences between the new procedure and the current procedure are that the new procedure must be completed within a certain period of time (285 days) if the request for reimbursement is filled by a company and will take more into account evidence based medicine.

Robin Maisonneuve, Project Manager, Johnson & Johnson DePuy France SAS)
Key success factors for commercialisation

This presentation aims to review the key factors leading to the successful commercialisation of a new medical device. These key factors will be examined by way of a practical study case: The development of an innovative reversed shoulder prosthesis. In accordance with the international regulatory reimbursement requirements, we will review how best to meet the patients' and the medical care professionals' needs with value-adding solutions.

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