Gilbert Regan PhD Student - PowerPoint Presentation

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Gilbert Regan

PhD Student

Traceability Assessment Model and Roadmap for the Medical Device Domain

Presentation Overview

Lero

/ RSRC Overview

Objectives of this work

Research Question/ Need for assessment model and roadmap

PAM and Roadmap development and validation

Idea for improvement

Supported by Science Foundation Ireland, by other state grants, by industry contributions and by external funding (particularly the EU’s research programmes).

Lero

is based in 8 Irish Universities, including DKIT

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Regulated Software Research Centre @DKIT

Mission: Gain an International Profile for Medical Device Software Engineering Research

Increasing Efficiency

Medical Device Software Roadmaps

Targeted Research

IEC 82304

IEC 62304 (IEC 80002-3

)

IEC

80001-2-7

IEC

80001-2-8 & IEC 80001-2-9

MDev

SPICE (ISO 330xx)

Medical Device Software Engineering / Processes

Safety-Critical Embedded Software

Traceability

CoursesTraining ModulesHDip

Education

Basic Research

Applied Research

Standards

4

Presentation Overview

Lero

/ RSRC Overview

Objectives of this work

Research Question/ Need for assessment model and roadmap

PAM and Roadmap development and validation

Idea for improvement

Medical Device Software

Software is a complex element of a medical device; it’s role, functionality and importance continually increases.

Standalone software can now be classed as an active medical device in its own right

(MDD 2007/47/EC).

Developing safety-critical software-based systems in a disciplined and cost-effective way poses major challenges (esp. with the move towards mobile devices, patient-driven applications, wireless devices and cloud-based solutions).

Highly

effective software practices

are required.

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Irish Medical Device Industry

Ireland’s medical technology sector is evolving into one of the leading global clusters for medical devices

– and has been identified by the Irish government as

one of the key drivers of industrial growth for the future

Irish

Medtech

in numbers

250

The number of

Medtech

companies in Ireland. 50% indigenous

€8

bn

The value of annual Irish

Medtech

exports

8.5%Of Ireland’s total merchandise exports

25,000The number of people employed in the industry7

Objectives

To assist existing medical device organisations improve how they implement traceability.

To assist existing medical device organisations assess their suppliers implementation of traceability.

To assist existing medical device organisations who do not currently produce software to begin producing software.

To assist organisations who want to move into the medical device domain.

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Presentation Overview

Lero

/ RSRC Overview

Objectives of this work

Research Question/ Need for assessment model and roadmap

PAM and Roadmap development and validation

Idea for improvement

Research Question

“To what extent can the development of a traceability assessment and implementation framework assist medical device software organisations improve their traceability practices and put them on the path to regulatory compliance?”

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Interview Findings

Interviews were conducted in 2 medical device organisations

Findings

Compliance issues: not meeting all traceability requirements from medical device standards and guidelines

Unaware of non-complianceUnfamiliar with

the

full benefits

of traceability

Unfamiliar

with the best practices for implementing traceability

Traceability is complex and burdensome

Tool issues

These findings, along with the practice of

‘

backfilling a trace matrix at the end of a project’ reinforce the need for traceability assessment and implementation models

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Need for a traceability assessment/ implementation models

Different medical device standards have different traceability

requirements

Process assessment

and improvement models such as

ISO/IEC 15504 SPICE, Automotive SPICE, SPICE 4 SPACE, and the Capability Maturity Model (CMMI) do not include a dedicated traceability assessment process

A Traceability Assessment Model will allow organisations

identify gaps

in their (and their suppliers) traceability and

provide guidance

on areas for improvement and establishment of effective traceability

.

Research has indicated that traceability is often

inadequately implemented

in medical device organisations, particularly SME organisations.

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Presentation Overview

Lero

/ RSRC Overview

Objectives of this work

Research Question/ Need for assessment model and roadmap

PAM and Roadmap development and validation

Idea for improvement

Process Assessment Model (PAM) Development Methodology

Assessment model based on ISO 15504 (SPICE) process assessment model

Traceability PAM

ISO 15504-2

Section 5 Measurement

Traceability PRM

Medical Device Standards and Guidelines

ISO 15504-2

Section 6.2

PRM

ISO/IEC TR 24774

Traceability Best Practices

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Structure of PAM

Each

of the processes contains:

Title

(ii)

Purpose, which contains the objectives

of the process

when performed

in a particular environment;

(

iii)

Outcomes

, which are

a list of

expected positive results

of performing the process (iv) Base practices, whose performance provides an indication of the extent of achievement of the process purpose and process outcomes(v) Work Products

are either used or produced (or both), when performing the process.

Traceability

PAMCM Trace Process

RM Trace Process

SDLC Trace Process

Trace ManagementProcess

Traceability Process Assessment Framework

4 Assessment Areas:

Change

Management

Risk Management

Software Development Lifecycle

Traceability Management – best practices(derived from literature)

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Validation of PAM

Initial validation through expert review and focus group

Risk Analysis

Risk Control

Meas

Hazard

Risk Evaluation

Software Cause

Hazard. Situat.

Software Item

Res. Risk Ass.

Risk Control Ver.

Modification Ver.

Sofware

Mod.

Problem Report

Change

Req

/App

Source

Software Req.

Code Class

Soft. Det. Des.

Software Arch

.

Des.

Sys. Arch. Des.

System Req.

Test Case

Test Case

Test Case

Test Case

Test Case

Test Case

Organisation A

Organisation B

Links made

Links made

Links not made

Links not made

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Roadmap Structure

Initial validation through expert review and focus group

Currently on industry trial

Introduction/Scope

Appendix A

- Difference between IEC 62304 and

ISo

12207

Section 1

- Roadmap Overview

Appendix

B - Traceability links and references to Standards

Section 2

- Traceability Processes, and Base Practices

Appendix C - Exemplar traceability methods and tasks

Section 3 - Implementation Case StudyAppendix D Traceability Best practices in detailSection 4 - Barriers and possible solutions

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Presentation Overview

Lero

/ RSRC Overview

Objectives of this work

Research Question/ Need for assessment model and roadmap

PAM and Roadmap development and validation

Idea for improvement

Future Work- idea for improvement

a system whereby all the necessary

artifacts would be accessible on the web (internet or intranet).

Open Sources for Lifecycle Collaboration (OSLC) is an initiative which aims to define standards for compatibility of Software Lifecycle tools and has become part of the OASIS Open Standards Network. http://open-services.net/

Every OSLC service uses the terminology and generally accepted approaches of the World Wide Web Consortium (W3C). One key approach is ‘Linked data’ being the primary technology leading to the Semantic Web (a common framework that allows data to be shared and reused across application, enterprise and community boundaries).

OSLC has core specifications which sets out the common features that every OSLC service is expected to support. The Core specification is actually the core on which all lifecycle elements must be built. The core defines the resource types, properties and operations to be supported. Examples of resources include defect, task, or any lifecycle

artefact

. The properties

describe these resource types and the relationships between them and all other resources

.

OSLC already includes a Change Management Specification which defines resource types, properties and operations

.

The OSLC Change Management(CM)

Vocabulary:

affectsRequirement

, implementsRequirement, tracksRequirement http://open-services.net/bin/view/Main/CmVocabulary#ChangeRequest19

Thank you

gilbert.regan@dkit.ie

Core funding provided by Science Foundation Ireland