Integrating IT into the Medical Device Development Process. Presented by: Nancy Paris, MASc, PEng, FEC March 31, 2011

Integrating IT into the Medical Device

Development Process

Presented by: Nancy Paris, MASc, PEng, FEC March 31, 2011

Presentation Outline

• Introduction to our research group

– Mission

– Expertise

– Facilities

– Services

• Development of our Quality System

• Integrating IT into our Medical Device Development Process

• Questions

Speaker Background

• Nancy Paris, MASc (Mechanical Engineering), PEng (Biomed)

• Director, Product and Process Applied Research Team (PART)

• Health Technology Research Group is a sub-group of PART

• My role is:

– Initiate the development of our quality system

– To ensure our quality system has the resources required to be successful

– To create a culture that supports a certified quality management system

– To be aware of trends in medical device development and ensure our quality system can address these trends

– One such trend has been the integration of IT into medical devices

BCIT Technology Centre – Health Technology

The Program's Mission

Since 1990 The BCIT Technology Centre (Health Technology) mission has been to promote growth in the B.C. and Canadian medical

products industries and improve the safety and efficacy of health technologies.

BCIT’s Vision – To be integral to the economic, social and environmental prosperity of British Columbia.

BCIT Technology Centre – Health Technology

Expertise

The Technology Centre has a multi disciplinary team with specialized expertise in engineering (bio-medical, mechanical), trades (machining and electrical),

technologies (plastics, electronics, mechanical, mechatronics and robotics), industrial design, biomechanics, orthotics, prosthetics, gerontology, etc.

BCIT Technology Centre – Health Technology

Facilities

The research group has access to extensive lab facilities fully equipped with electronic prototyping equipment, machine tools, a full range of medical

equipment, test equipment, specialized medical devices, a computerized data acquisition system and a computerized motion analysis system.

BCIT Technology Centre – Health Technology

Services

The Technology Centre provides a wide range of services to its industry clients.

Health technology services run under an ISO 13485 certified quality management system in key components of developing new

marketable health products including: • Design requirements

• Conceptual design

• Detailed design

• Prototype fabrication

• Verification & Validation and

Vibro-tactile Belt

for anaesthesiologists

• Collaboration with UBC

• Used in a clinical research study

BCIT Technology Centre – Health Technology

Development of our Quality System

• In 2000 the HTRG embarked on the development of a quality system that complied with ISO 13485 Medical devices -- Quality

management systems -- Requirements for regulatory purposes (ISO 13485) to better serve our clients.

• If your product is regulated as a medical device then your company will have to develop a medical device quality

BCIT Technology Centre – Health Technology

Development of our Quality System

• An initial system was developed and launched in 2002.

• Initially a small number of targeted SOPs were

developed to address hazard analysis and other specific design requirements (e.g. design reviews).

• The benefit of starting this way is that everyone can be involved in the development of these

procedures to develop buy in from the team.

• Avoid isolation of your quality system team!

BCIT Technology Centre – Health Technology

Development of our Quality System

• In 2005 we further developed the system to be fully compliant with all requirements of ISO 13485 and obtained certification of the system in 2007.

• To complete the quality system requires full commitment from top management and the design team.

Commitment means providing the resources

required to develop the system, train staff, conduct internal auditing and conduct external auditing for the purposes of certification. Cost is much higher.

• The BCIT HTRG is currently the only ISO 13485 certified academic medical device research group in Canada.

BCIT Technology Centre – Health Technology

BCIT Technology Centre – Health Technology

Integration of IT into our Medical Device Development Process

QS PROCEDURE 3.0.2 Developing Software Used in Medical Devices PURPOSE

This procedure defines the steps taken to develop software used in Medical Devices.

SCOPE

This procedure applies to all medical device applied research projects conducted by the organization which have software components.

REFERENCES

IEC 62304: 2006 Medical device software – Software Life Cycle Processes ISO 14971: Application of Risk Management to Medical Devices

IEC TR 80002-1 Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software

BCIT Technology Centre – Health Technology

Integration of IT into our Medical Device Development Process

QS PROCEDURE 3.0.2 Developing Software Used in Medical Devices RESPOSIBILITIES

Project Lead:

Ensures planning and documentation (design specifications) are adequate for software component of the project.

Ensures requirements for medical device software are identified and are met.

Ensures design changes made to the software during each phase are controlled using design change procedure and form after the ding phase of the project. .

Ensures appropriate Hazard Analysis is completed prior to Design Review. Ensures design outputs are adequate for the next phase.

BCIT Technology Centre – Health Technology

Integration of IT into our Medical Device Development Process

DEVICE DESIGN REQUIREMENTS SOFTWARE DESIGN REQUIREMENTS SOFTWARE DEVELOPMENT PLANNING PROJECT PLANNING DEVICE CONCEPT DEVELOPMENT SOFTWARE ARCHITECTURE DESIGN DEVICE DETAILED DESIGN SOFTWARE DETAILED DESIGN DEVICE FABRICATION SOFTWARE IMPLEMEN TATION DEVICE VERIFICATION SOFTWARE VERIFICATION DEVICE DELIVERY SOFTWARE RELEASE QS DEVELOPMENT PROCESS S/W DEVELOPMENT PROCESS END END

Summary

• If your product is regulated as a medical device then your company will have to develop a medical device quality

management system.

• Software development is a component of the medical device development process that must be integrated into your

quality system.

• Senior management commitment is required for successful implementation of your quality system.

• Many resources are available to support a compliant system.

• Questions?