The primary objective of the workshop is to transform the existing understanding of the attendees to a platform that builds confidence in them to take biotech as an opportunity rather than as the mystic field of a few experts.

The workshop will provide in-depth understanding of the biotech business – not from the aspect of biotech lab sciences.

Attendees will be able to identify the inefficiencies in the field and with their high-tech knowledge they will be able to solve these inefficiencies; thus, a new business opportunity can be created.

Investors will have a better understanding to value a venture; make right decisions on when to get-in and when to get-out. This workshop is equivalent to the Tony Robin’s walking through the fire–(without the fire) – to break the fear.

More specifically –

MEDICAL DEVICE ENTREPRENEURSHIP PROCESS
 

The development of new medical devices is a highly inventive and creative process. A valuable insight is unveiled into the entire Medical Device Startup process from Concept Generation to market penetration. Infused with real-world examples, the workshop will address the FDA regulations, the different classes of medical devices, 510K, the PMA process and strategic issues in device development. This workshop provides an important foundation in medical device development for professionals from all disciplines who are currently working in or are considering a move to the Medical Device industry.

Participant outcomes: At the end of the course, participants will

• Understand what is a Medical Device.

• Get an idea of how the FDA classifies Medical Devices.

• Understand the scientific and technology process involved in inventing a new medical device.

• Identify the different phases and processes for the clinical evaluation of new medical devices.

• Be enlightened as to how the various concepts in engineering and medical science get embedded into the medical devices.

• What are the Classes of Medical Devices.

• Medical Device Concept and Design.

• Regulatory Pathways for Medical Devices and the FDA interface.

• The 510 K and the PMA.

• Marketing Medical Devices successfully.

Workshop format

This course will use PowerPoint slides, flip chart, group discussions and brainstorming as the primary mode of knowledge transfer. Participants are encouraged to share on the job experiences to which relevant Medical Device principles are applicable. Group exercises make the workshop very interactive.