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

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

2 Presentation Outline Speaker background Introduction to our research group Mission Expertise Facilities Services Development of our Quality System Integrating IT into our Medical Device Development Process Questions

3 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

4 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.

5 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.

6 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.

7 Services The Technology Centre provides a wide range of services to its industry clients. Health technology services run under an ISO 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 Design for manufacture

8 Vibro-tactile Belt Haptic feedback system for anaesthesiologists Collaboration with UBC Used in a clinical research study

9 Development of our Quality System In 2000 the HTRG embarked on the development of a quality system that complied with ISO 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 management system!

10 Development of our Quality System An initial system was developed and launched in 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! The cost is low.

11 Development of our Quality System In 2005 we further developed the system to be fully compliant with all requirements of ISO and obtained certification of the system in 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 certified academic medical device research group in Canada.

13 Integration of IT into our Medical Device Development Process

14 Integration of IT into our Medical Device Development Process QS PROCEDURE 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 Medical device software Part 1: Guidance on the application of ISO to medical device software

15 Integration of IT into our Medical Device Development Process QS PROCEDURE 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. Ensures the final output conforms to the initial design and architecture requirements.

16 Integration of IT into our Medical Device Development Process Development Process Comparison QS DEVELOPMENT PROCESS S/W DEVELOPMENT PROCESS PROJECT PLANNING SOFTWARE DEVELOPMENT PLANNING DEVICE DESIGN REQUIREMENTS SOFTWARE DESIGN REQUIREMENTS 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 END END

17 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? Website:

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