inemi Statement of Work (SOW) Medical TIG Qualification Methods for Portable Medical Products Version 2.2 Date: December 16, 2011 Project Leader: Grady White, NIST Project Co-leader: Jack Zhu, Boston Scientific inemi Staff: Grace O Malley Basic Project Information The project has been identified as the result of input from the medical electronics communities participation in inemi-run workshops and focus groups in 2010 and 2011. It is perceived that there is a lack of cohesion or an absence of a standardized approach to evaluation methods for determining the reliability performance of medical devices. There are many different types of medical electronics systems; however, the major products can be classified into three categories: 1) large infrastructure equipment, 2) portable medical devices, and 3) implantable medical devices. This project will focus on the portable medical devices. Problem Statement The medical electronics industry is developing very quickly. Historically, the industry has been vertically integrated with a narrow supply base. The market has been conservative and slow to introduce new technologies and products. Both the rapid growth of the use of electronics in medical devices and the recent market-driven need to shorten time to market for new products has revealed the lack of a consistent approach in determining the reliability performance of devices, such as is done in the military applications through use of Military Standards (MIL STDs). This results in time-consuming and redundant testing at many stages of the product development and qualification cycle. Development of a standard methodology and qualification procedures would enable the industry to enact changes more quickly and to bring products to the market in a shorter time. Portable medical devices are products such as patient monitoring systems that are used to measure and monitor patients vital signs and other bodily functions, including home diagnostics NOTE: All changes to SOW must be approved by the Technical Committee for version control Page 1 of 6
products such as blood pressure cuffs (including wireless), blood glucose meters, pulse oximeters, and biochemical analysis meters. The peripheral products of the implantable medical systems, such as external chargers and remote controls, also belong to this category. Even though a failure of most types of portable devices will typically not impose immediate risk to patient life, the impact of failure on consumer confidence in self and remote monitoring requires that both the medical device manufacturer and supplier industries understand and optimize the reliability and, concomitantly, qualification requirements. Compared with large infrastructure devices like x-ray systems or small implantable devices, such as pacemakers, portable medical devices have a larger production volume and, thus, a larger user base. For implanted devices, the external supporting electronic devices are critical to routinely maintain or monitor the active implanted components and, thereby, can greatly impact the patient s life quality. This project will develop a reliability qualification method for portable electronic medical devices, including the peripheral products of implantable systems. Scope of Work This project is intended to: o Combine OEM and EMS expertise to identify current best known practices in assessing reliability of portable electronic devices, o Identify those procedures that can be applied in assessing portable medical devices, o Identify any gaps in those procedures, and o Obtain a set of procedures acceptable to the medical electronics industry for assessing reliability of portable medical electronic devices. This schedule will include: o Months 1 2: (Task 1) Identify companies and champions to lead investigations Select and identify task leaders Select and identify task members o Months 3 6: (Task 2) Identify what tools and methodologies already exist Identify extant reliability tools and standards Identify gaps in tools and needed standards o Months 6 13: (Task 3) Identify how to address the identified gaps Identify extant tools that cover all or most of the gaps Identify potential solutions for identified gaps Identify needed additional knowledge (e.g., external expertise, required research, additional statistical tools) NOTE: All changes to SOW must be approved by the Technical Committee for version control Page 2 of 6
o Months 13 15: (Task 4) Conclusion of the project Define appropriate reliability standards protocols Identify remaining needs Agree upon transition of results to appropriate standards organization o Month 16: (Task 5) Final report Final report to inemi Purpose of Project The primary purpose of the project will be to provide a solution in the form of a methodology that can be used to qualify the reliability performance of portable electronic medical devices. There is a greater emphasis on reliability for portable medical electronic devices than there is for comparable devices not used in medical applications and, therefore, a greater need for industryaccepted reliability assessment procedures for these devices. It is anticipated that this project will result in a standard reliability method that can be implemented in those cases for which the failure mechanisms or test methods are known. For those situations in which the failure mechanisms or test methods are not known, it is anticipated that this project will provide part of a more complex solution. The anticipated benefits to participants, to the inemi membership in general, and the industry are: An industry-wide approach to qualifying the reliability performance of portable medical devices will enable the industry to grow faster. A shorten the time to market and also the time to adopt and integrate new technologies into portable electronic medical devices. An industry-wide approach will provide regulatory bodies with standardized criteria for acceptance of new devices or device designs. Industry-wide qualification procedures, supported across the supply chain, will reduce redundant costly testing and increase confidence in the qualification procedures. NOTE: All changes to SOW must be approved by the Technical Committee for version control Page 3 of 6
Project Is / Is Not Analysis This Project IS: Focusing on portable medical devices, including standalone devices and peripheral devices for implantable systems. Identification of existing industry reliability tools and standards Identification of gaps in existing industry tools for medical devices Identification or development of well-defined, industry-accepted lifetime/reliability assessment procedures for portable medical devices This Project IS NOT: A determination of failure processes or time dependence To define accelerated test parameters for components or devices To identify failure processes or conduct extensive reliability test A test method development activity Business Impact Standardized qualification processes reduce the overall qualification cost because qualification time will be reduced and additionally OEMs will no longer need to spend money and resources to define the qualification processes every time a new portable device is developed. Instead they will be able to utilize existing processes that are pre-defined for various devices. Outcome of Project It is envisioned that the outcome of this Project will include a final report that contains a review of the industry status for qualification of portable electronic medical devices, a description of the assessment procedures, and a listing of current industry approaches with detailed discussion of identified gaps and gap mitigation procedures. It is hoped that the final results of the project will be moved into an identified standards body that will codify the procedures. Sharing Project Results: The project participants will determine what information will be shared outside of the team. Previous Related Work A review will be conducted as part of Task 2 of the project. Prospective Participants Medical Electronic Implant Companies: e.g., St. Jude Medical, Biotronik, Boston Scientific, Medtronic, Med-el, Cochlear, Sorin Portable Electronic Medical Device Manufacturers: e.g., Baxter, GE Medical, Siemens, Philips Healthcare, Sony EMS: Benchmark, Celestica; Plexus, Sanmina-SCI, Flextronics Suppliers: Endicott Interconnect Technologies Inc. Others: NIST, CALCE NOTE: All changes to SOW must be approved by the Technical Committee for version control Page 4 of 6
Project Plan Schedule Q1 Q2 Q3 Q4 Q5 Q6 Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Phase 1 Task 1 x x Identify companies and champions to lead investigations Task 2 x x x x Identify what tools and methodologies already exist Task 3 x x x x x x x x Identify how to address the identified gaps Task 4 x x x Conclusion of the project Task 5 x Final report Detailed Information Months 1 2: Task 1 - Identify companies and champions to lead investigations o Select and identify task leaders o Select and identify task members Months 3 6: Task 2 - Identify what tools and methodologies already exist o Identify extant reliability tools and standards o Identify gaps in tools and needed standards Months 6 13: Task 3 - Identify how to address the identified gaps o Identify extant tools that cover all or most of the gaps o Identify potential solutions for identified gaps o Identify needed additional knowledge (e.g., external expertise, required research, additional statistical tools) NOTE: All changes to SOW must be approved by the Technical Committee for version control Page 5 of 6
Months 13 15: Task 4 - Conclusion of the project o Define appropriate reliability standards protocols o Identify remaining needs o Agree upon transition of results to appropriate standards organization Month 16: (Task 5) - Final report Final report to inemi Project Monitoring Plans Ensure open lines of communication among participants. Review all project requirements with participants before the project begins. Project participants will meet bi-weekly to review various aspects of the project and make plans for next phases of the project. Meeting minutes provided through e-mail. Follow-up with individuals on an as-needed basis. Provide any project specific monitoring or communications plans, e.g., multiple project meetings to cover multiple regions (EMEA, Asia, Americas). Workshops and face-to-face meetings as determined by the project team. Progress reports will be provided upon request for presentation at regularly scheduled inemi meetings (e.g. a short series of PowerPoint slides showing the work in progress at member council meetings). Track and document approximate man-months per quarter per team member (this will require the active members of the team to provide estimates). Track and document approximate number of people on the project per quarter (this can be tracked through inemi's WebEx account). General and Administrative Guidelines General and Administrative Guidelines for this project and all other inemi Projects are documented at http://thor.inemi.org/webdownload/join/gen_guidelines.pdf. NOTE: All changes to SOW must be approved by the Technical Committee for version control Page 6 of 6