Medical Device Development - Trends, Challenges and Risks

Medical Device Development – Trends, Challenges and Risks

Dina Sifri CEO

Med-Dev Design

Medicine &Technology Riddle

Medicine &Technology Lifecycle

Unmet medical

need

Innovation

Development

Clinical trials /

Validation

Change in medical practice

Medicine &Technology Advancement

Agenda

www.meddev-design.com

Agenda

Medical Trends

Medical Trends Today

• Customer tailored medicine - Personal

Medicine

• Repair, restore, replace organs, tissues, cells

• Global and instant access to medical info

• Homecare health

• Mobile medicine

• Prevention

• Healthcare & Wellness

Medical Health Trends

Medical Trends Shift

Today:

Detect & Treat

Tomorrow: Predict & Prevent

Technological / Science Advantage

Biomedical Science

• Genomics

• Stem Cells

• Vaccines

• Pharmaceutical

• Diagnosis

Computer / Engineering

• Devices: Small, powerful

• Imaging: not just X-Ray

• OR of the future

• Medical Info managing

• Telemedicine

• Mobile technology

• Robotics

• 3D printing of organs

• Nanotechnology

• Brain-computer interface

Sciences Trends

Digital Medicine Robotic Surgery Nanomedicine

Genomics Neuro Connected Health

Global Medical Challenges

Global Medical Challenges

• Chronic diseases

• Baby boom generation

• Live longer

• Life style

• Physicians/patient ratio

• Regulation of Innovation

• Healthcare reforms

• Healthcare costs

• World wide environment

Global Medical Challenges

Cost

Demographics

Access

Variation in clinical practice

Insufficient Use of

information

Fragmented care versus

integrated care

Duplication, defensive medicine &

waste

Protracted Adoption of

Innovation

Thechnological Challenges

Technological Challenges

• Electronics

• Mechanics

• Software

• IT networking

• Cyber security

• Multimodality

• Maintenance

• Usability

Software Strengths

• Operation system

• Powerful computing

• Smartphones

• Embedded

• Graphical cards

• Open source

• Libraries

• Knowledge sharing

Software Strengths

Risks: Medical/ Technological/Regulation

• R&D hurdles/technology

• Time to market

• Competition

• IPs

• Costs/Revenue

• Reimbursement

• Payers: customers

• Risks from payers to providers

• Global crisis

www.meddev-design.com

Medical Devices Lifecycle

Healthcare Delivery Process

Treatment

Rehabilitation

Diagnosis

Prevention

Use of Medical Device

Knowledge Creation

Medical Device - Lifecycle

SWOT

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