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Launching medical devices and associated software: an integrated approach?
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Leuven.Inc, in co-operation with K.U.Leuven Research & Development and LMTC (Leuven Medical Technology Centre) are happy to invite you to their seminar:  “Launching medical devices and associated software: an integrated approach?”,

This one day program has been specially designed to offer an integrated approach for successfully launching medical devices and associated software.

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
               

Program

 

- 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: How can patent strategies benefit your business: an SME perspective
- Koenraad Van Schuylenbergh (R&D Director, 3WIN )

- 12u00

Questions and answers

- 12u30

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
- Jaak Minten (Clinical Research Director Cardiac Surgery)

Materialise: Integration of regulatory aspects in the medical software process
- Sabine Demey (Director Software Development Materialise & Department Manager CMF)

- 15u10

Coffee/tea break

- 15u45

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.

- Ulla Cahay (Attaché, Dienst Geneeskundige Verzorging, RIZIV)

- 16u30

Case: Key success factors for commercialisation
- Robin Maisonneuve (R&D Director, Johnson & Johnson DePuy France SAS)

- 17u00

Final conclusions

 

Participation fee

 

180 euro (excl. VAT): academic researchers
270 euro (excl. VAT): members Leuven.Inc / LMTC (1)
320 euro (excl. VAT): all others (2)

 

(1): 240 euro per person if more delegates of the same company subscribe

(2): 290 euro per person if more delegates of the same company subscribe

 

Registration

 

Register now by e-mail admin@leuveninc.com or by faxing this registration form to fax 016 40 81 47. After registration you will receive a confirmation and route description. The registration fee is payable after reception of invoice.
Cancellation after subscription is not possible. However, replacement by a colleague is allowed.*

For more information:

 

* Nicole De Smyter, tel: + 32 (0)16 40 11 90