The document summarizes key aspects of applying agile principles and practices to medical device software development in a way that is compliant with regulatory requirements. It discusses how agile values such as individuals and interactions over processes and tools, working software over comprehensive documentation, customer collaboration over contract negotiation, and responding to change over following a plan can be aligned with regulatory needs to develop software that is safe, effective, and meets user needs. The document provides examples of how agile practices such as planning, requirements, and documentation can be adapted for medical device software while maintaining regulatory compliance.
ISO 62304: Defines processes that are required in any given SDLC to ensure that it compiles with the creation or maintenance medical device software
Andy Stopford has over 16 years experience leading teams to deliver pioneering software solutions that enable business goals to be achieved. With experience drawn from the e-commerce, financial, insurance, banking and healthcare sectors he is committed to creating quality software that adheres to best practices and delivers solutions that are robust and help clients achieve business goals.
Andy is a software engineer by trade and is a published book author and keen writer with 200 magazine and journal articles over his career. He has a great depth and breadth of knowledge in a variety of technologies and is passionate about all things software engineering.
Andy leads the HAVAS HEALTH SOFTWARE team of software engineers to develop solutions that focus on the best possible outcome for the end user that ensure the business needs are met.
@andystopford
Death by documentation - Medical Device Development ChallengesAligned AG
“Writing documents and putting them into binders does not sound like rocket science.”
Nevertheless, many of us have experienced how documentation and traceability according to ISO 13485 and FDA QSR 820 turns into a both complex and cumbersome activity. Surprisingly enough, as long as regulatory demands are met, the documentation process itself is seldom scrutinized for efficiency improvements.
This presentation highlights how great savings can be made in this area. We uncover bad documentation practices, their consequences and potential remedies with the intent to make the medical device documentation process more efficient.
The FDA recommends implementing a coding standard during medical device software development. In practice, this means running a static analysis tool to detect any problematic constructs that could lead to problems down the road.
But if you think you can simply download an analyzer and go, you might consider that the FDA requires documented details associated with code quality activities.
What standard are you going to check against? What rules in the analyzer cover the standard? Which rules are you suppressing? The implementation of static analysis is enough to cause headaches, gastrointestinal discomfort, and other side-effects.
This webinar prescribes some static analysis implementation best practices to relieve your FDA compliance symptoms, including:
The benefits of static analysis and what to look for in an analyzer
How to automate static analysis execution
How to integrate static analysis within your software development processes.
How to reduce noise and stop wasting time manually triaging results
When created early in the product development lifecycle, a trace matrix can do more than just help you gain FDA approval for your device. Unfortunately, many companies create the matrix sporadically during a project, mainly right before regulatory submission—too late to capture the benefits a well-maintained matrix can deliver.
During this recorded webinar, guest speaker Steve Rakitin, President of Software Quality Consulting, discussed five of the benefits gained by maintaining a matrix throughout the project. A software engineer with more than 20 years of experience in the medical device industry, Steve explains how a trace matrix can help you:
- Plan and estimate testing and validation needs
- Ensure all requirements are implemented
- Verify that all requirements have been tested
- Manage change throughout product development
- Provide evidence that hazard mitigations are implemented and validated
ISO 62304: Defines processes that are required in any given SDLC to ensure that it compiles with the creation or maintenance medical device software
Andy Stopford has over 16 years experience leading teams to deliver pioneering software solutions that enable business goals to be achieved. With experience drawn from the e-commerce, financial, insurance, banking and healthcare sectors he is committed to creating quality software that adheres to best practices and delivers solutions that are robust and help clients achieve business goals.
Andy is a software engineer by trade and is a published book author and keen writer with 200 magazine and journal articles over his career. He has a great depth and breadth of knowledge in a variety of technologies and is passionate about all things software engineering.
Andy leads the HAVAS HEALTH SOFTWARE team of software engineers to develop solutions that focus on the best possible outcome for the end user that ensure the business needs are met.
@andystopford
Death by documentation - Medical Device Development ChallengesAligned AG
“Writing documents and putting them into binders does not sound like rocket science.”
Nevertheless, many of us have experienced how documentation and traceability according to ISO 13485 and FDA QSR 820 turns into a both complex and cumbersome activity. Surprisingly enough, as long as regulatory demands are met, the documentation process itself is seldom scrutinized for efficiency improvements.
This presentation highlights how great savings can be made in this area. We uncover bad documentation practices, their consequences and potential remedies with the intent to make the medical device documentation process more efficient.
The FDA recommends implementing a coding standard during medical device software development. In practice, this means running a static analysis tool to detect any problematic constructs that could lead to problems down the road.
But if you think you can simply download an analyzer and go, you might consider that the FDA requires documented details associated with code quality activities.
What standard are you going to check against? What rules in the analyzer cover the standard? Which rules are you suppressing? The implementation of static analysis is enough to cause headaches, gastrointestinal discomfort, and other side-effects.
This webinar prescribes some static analysis implementation best practices to relieve your FDA compliance symptoms, including:
The benefits of static analysis and what to look for in an analyzer
How to automate static analysis execution
How to integrate static analysis within your software development processes.
How to reduce noise and stop wasting time manually triaging results
When created early in the product development lifecycle, a trace matrix can do more than just help you gain FDA approval for your device. Unfortunately, many companies create the matrix sporadically during a project, mainly right before regulatory submission—too late to capture the benefits a well-maintained matrix can deliver.
During this recorded webinar, guest speaker Steve Rakitin, President of Software Quality Consulting, discussed five of the benefits gained by maintaining a matrix throughout the project. A software engineer with more than 20 years of experience in the medical device industry, Steve explains how a trace matrix can help you:
- Plan and estimate testing and validation needs
- Ensure all requirements are implemented
- Verify that all requirements have been tested
- Manage change throughout product development
- Provide evidence that hazard mitigations are implemented and validated
Quality, quality concepts
Software Quality Assurance
Software Reviews
Formal Technical Reviews
SQA Group Plan
ISO 9000, 9001
Example
Internal and external attributes
Software validation do's and dont's may 2013John Cachat
Software validation is often times a very misunderstood concept. For FDA regulated industries, there are clear expectations including “the least burdensome approach.” Validation alone does not guarantee software quality—many other aspects of software engineering are required.
Join software expert, John Cachat, as he discusses how to solve several software validation issues, including:
Requirements
Defect Prevention
Time and Effort
Software Life Cycle
Plans
Procedures
Software Validation After a Change
Validation Coverage
Independence of Review
Flexibility and Responsibility
A Research Study on importance of Testing and Quality Assurance in Software D...Sehrish Asif
A Research Study on importance of Testing and Quality Assurance in Software Development Life Cycle (SDLC) Models & Quality Assurance for Product Development using Agile & A Software Quality Framework for Mobile Application Testing
General Principals Of Software Validationstaciemarotta
This guidance outlines general validation principles that the Food and Drug Administration (FDA)
considers to be applicable to the validation of medical device software or the validation of software
used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0,
supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June
9, 1997.
A Guide to the Forthcoming 2012 Revision of the IEEE Software Quality Assuran...dheimann5
The IEEE is in the process of updating and adding significant content to its IEEE-730-2002 standard on Software Quality Assurance (SQA). The new version will coordinate with the four process areas and sixteen SQA tasks in the IEEE-12207-2008 standard “Systems and Software Engineering: Software Life Cycle Processes”, providing detailed elaborations for these areas and tasks.
The presentation provides a brief overview of these areas and tasks, discuss the difference between SQA and testing, and cover the annexes in IEEE 730 that provide industry-specific information as well as the relationships with software process approaches such as CMMI, Agile, SPICE, CSQE, PMBOK, and VSEs.
CSS in React is a talk I gave at the ReactJS San Francisco Bay Area meetup yesterday. It covers viable options for implementing CSS in JavaScript React components and the good and bad parts of various solutions including Radium, react-css-modules, styled components, combined with Sass, Webpack, Babel, and ES6.
It also includes a github repo https://github.com/joeshub/css-in-react where you can run all the examples locally
An overview of the CSS preprocessor LESS.
Including code samples for creating mixins, variables, math, colors, patterns, guards, scope, and namespaces.
Quality, quality concepts
Software Quality Assurance
Software Reviews
Formal Technical Reviews
SQA Group Plan
ISO 9000, 9001
Example
Internal and external attributes
Software validation do's and dont's may 2013John Cachat
Software validation is often times a very misunderstood concept. For FDA regulated industries, there are clear expectations including “the least burdensome approach.” Validation alone does not guarantee software quality—many other aspects of software engineering are required.
Join software expert, John Cachat, as he discusses how to solve several software validation issues, including:
Requirements
Defect Prevention
Time and Effort
Software Life Cycle
Plans
Procedures
Software Validation After a Change
Validation Coverage
Independence of Review
Flexibility and Responsibility
A Research Study on importance of Testing and Quality Assurance in Software D...Sehrish Asif
A Research Study on importance of Testing and Quality Assurance in Software Development Life Cycle (SDLC) Models & Quality Assurance for Product Development using Agile & A Software Quality Framework for Mobile Application Testing
General Principals Of Software Validationstaciemarotta
This guidance outlines general validation principles that the Food and Drug Administration (FDA)
considers to be applicable to the validation of medical device software or the validation of software
used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0,
supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June
9, 1997.
A Guide to the Forthcoming 2012 Revision of the IEEE Software Quality Assuran...dheimann5
The IEEE is in the process of updating and adding significant content to its IEEE-730-2002 standard on Software Quality Assurance (SQA). The new version will coordinate with the four process areas and sixteen SQA tasks in the IEEE-12207-2008 standard “Systems and Software Engineering: Software Life Cycle Processes”, providing detailed elaborations for these areas and tasks.
The presentation provides a brief overview of these areas and tasks, discuss the difference between SQA and testing, and cover the annexes in IEEE 730 that provide industry-specific information as well as the relationships with software process approaches such as CMMI, Agile, SPICE, CSQE, PMBOK, and VSEs.
CSS in React is a talk I gave at the ReactJS San Francisco Bay Area meetup yesterday. It covers viable options for implementing CSS in JavaScript React components and the good and bad parts of various solutions including Radium, react-css-modules, styled components, combined with Sass, Webpack, Babel, and ES6.
It also includes a github repo https://github.com/joeshub/css-in-react where you can run all the examples locally
An overview of the CSS preprocessor LESS.
Including code samples for creating mixins, variables, math, colors, patterns, guards, scope, and namespaces.
This is my current work and thinking on how to do Scrum within heavily regulated industries like healthcare, government, and finance. For more information join my community at http://scrumandcompliance.com/
Agility With Care: Managing Requirements Change with Agility In A Regulated P...Ken Wong
This presentation looks at some of the potential challenges involved in employing Agile requirements management approaches in a regulated product environment. The key is finding the right blend of agile and plan-driven methods depending upon the development context.
Companies in multiple industries have found that lean and agile methods speed up their product development while simultaneously improving quality and cutting costs. In spite of these proven advantages, these methods have not been widely adopted in the highly regulated medical device industry. Regulations and standards do not prevent the adoption of lean and agile methods but many companies’ quality systems do. Understanding these barriers and how to modify quality system procedures is key to more efficient medical device development and improved compliance.
How can we reconcile the light touch approach of agile development teams to the governance and information security requirements such as Data Privacy and Regulatory Compliance? I discuss how to bring together the apparently conflicting needs of information security and agile, and show by example how agile teams actually approach tough regulatory requirements and good governance.
Presentation by Pathfinder Software to the Agile Project Management Group and Health 2.0 group on how to get the benefits of agile development in an FDA regulated environment, based on Pathfinder's experience developing software for medical devices
SXSW Panel Picker slide show for Agile Development and the FDA
Developing software for the healthcare sector is difficult enough, but doing so under the scrutiny of the FDA can seem impossible. However, if you want to have an impact at the point of patient care the FDA is going to be a factor in your development. We will look at ways to marry the seemingly contradictory philosophies of Agile development, with its high efficiency, low documentation process, with the FDA regulated requirements of complete audibility and seemingly endless piles of paperwork. Through a real-life case study we will looks at modern software development practices through the lens of the FDA.
Agile Development – Why requirements matter by Fariz SaracevicBosnia Agile
The clear benefits of agile development is a better collaboration, incremental delivery, early error detection and the elimination of unnecessary work—have made it the default approach for many teams. Some developers have questioned whether requirements fall into the category of unnecessary work, and can be cut down or even completely eliminated. Meanwhile, teams developing complex products, systems and regulated IT continue to have requirements-driven legacy processes.
So how does requirements management fit in an agile world? This session will take a look at requirements management and how it can bring significant value to agile development in regulated IT and complex product development projects, and sets out the characteristics of an effective requirements management approach in an agile environment.
Agile Adoption and Transformation in a regulated environmentagile42
Presented by Christian Beck at agile42 Connect conference in Berlin, November 2015 – Developing medical device software for an international market is a heavily regulated activity that needs to be compliant with a considerable number of national and international laws and standards. Company culture is therefore heavily biased towards process orientation, predictability and control. On the other hand, the complexity of medical devices in today's information technology landscape in healthcare is only manageable by applying agile development principles and practices. How can a ScrumMaster help his or her teams to navigate successfully through this environment of conflicting messages? I will share with you how we at MeVis managed this challenge by forming self-confident teams and a strong Scrum Master role model along with number of hands-on practices that proved to be most helpful in our context.
Agile Development for FDA Regulated Medical SoftwareOrthogonal
The FDA regulates software for medical devices, and may in future regulate mobile medical software as well. Can you speed up time to market with Agile development in an FDA regulated medical environment?
Pathfinder Software shares their experience developing software using lean ux and agile software development best practices for medical devices and mobile medical software.
Regulated Software Testing - Griffin Jones - TISQA 2014Griffin Jones
Regulated software is consequential software, subject to authoritative outside review. Even experienced software testers can have an Alice-In-Wonderland feeling the first time they test a regulated product. Many aspects of software testing are surprisingly exactly the same as testing unregulated software, while others are surprisingly completely different. Why is that? What parts are surprisingly similar or different? Griffin shares experiences of testing FDA regulated systems, and similar software (e.g., financial systems, aircraft controls, insurance, and online gaming) – drawing examples from the participants of the Workshop on Regulated Software Testing (WREST), and himself. We examine the what, why, and how certain software is regulated - and the duties imposed on companies and individuals. We highlight some of the surprising aspects, such as: test design and execution; tools and automation; accuracy and rigor; traceability and authorization; evidence and record keeping; the halting problem; process standardization and predictability; human variability and adaptability; technology choices; morality and ethics; and business pressures. Leave with more insight into and less surprise about the challenges of testing regulated software.
The medical device industry is facing unprecedented challenges due to emerging technologies and increased regulatory scrutiny.
Current “waterfall” product development methods are ill-suited to dealing with the pace of change and uncertainty that product development organizations are facing. This eBook addresses:
* The shortcomings of waterfall development specifically in regulatory environments.
* How agile development meets the safety, reliability and regulatory needs of the medical device and diagnostics industry.
* How agile development can help ensure delivery of successful software.
Agile software development is a group of software development methods in which requirements and solutions evolve through collaboration between self-organizing, cross-functional teams. It promotes adaptive planning, evolutionary development, early delivery, continuous improvement, and encourages rapid and flexible response to change.
The Agile development model is also a type of Incremental model. Software is developed in incremental, rapid cycles. This results in small incremental releases with each release building on previous functionality. Each release is thoroughly tested to ensure software quality is maintained. It is used for time critical applications.
Estimation of agile functionality in software developmentBashir Nasr Azadani
Estimation of Agile Functionality in Software Development - ISBN: 978-988-98671-8-8
Publication date: Mar 21, 2008 presented at International MultiConference of Engineers and Computer Scientists 2008 Vol I
This is one of many Agile Tutorial slides available at http://www.avidanhetzroni.com/agile-tutorial/
In this slides deck, Avidan Hetzroni explains the basic concepts behind the Manifesto for Agile Software Development (a.k.a Values) and Principles.
Defines software quality and provides detailed activities of SQA along with software change management delivered to post-graduate students of Object Oriented Software Engineering.
Agile is software development technique in which the software is developed in a way that quality of software is good and the time required to development is less and the development takes place by parts, i.e. The software delivered to the user or customer by parts in a short period of time. The agile methodology introduced simple, easy to follow ideas that revolutionized how teams approach software delivery.
Mobile app development is an ever-evolving industry that requires a flexible and adaptive approach. To keep up with the rapidly changing market demands and stay ahead of the competition, development teams need to work efficiently and effectively. One of the best methods for mobile app development is Agile Framework.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
4. The State of Software Development
(~2001)
Isolated developers working independently
Each owning a part of the project
Communicating via data flow diagrams, interface contracts,
UML, CASE tools, and detailed specs
Updating the boss through weekly status reports
Finally coming together for ‘Big bang’ integrations
Followed by endless bug fixes and ‘crunch time’
“Individuals and interactions
over processes and tools”
5. The State of Software Development
(~2001)
Design documentation handed to developers to ‘code’
Complete products requirements generated by business analysts
Software design description produced by a technical architect
Detailed design docs written ‘up-front’
No code written until design docs approved
“Working software
over comprehensive documentation”
6. The State of Software Development
(~2001)
The customer and the software teams were adversaries
Negotiated scope and expensive change orders
The ‘Iron Triangle’
Features, Time/Budget, Quality (Pick Two)
User’s got the software that was designed for them;
Not the software that they wanted
“Customer collaboration
over contract negotiation”
7. The State of Software Development
(~2001)
The Plan was a project-wide GANTT chart that fixed the
schedule for the remainder of the project
Tracking task status by percent complete
Except that tasks rapidly reached 90%
Then slowly crept to 100% (and even that was often a ‘fudge’)
New or changing requirements were met with
resistance, rejection or big budget overruns
“Responding to change
over following a plan”
11. What does typical
Agile Software Development
look like?
Small, interdisciplinary teams of developers, testers, and customer
proxies
Often co-located in an open workspace with highly visible status displays
Code is owned by the whole team and members often work together in
pairs
Test-Driven Development, Automated Builds, Continuous Integration
User stories (features with independent value) are managed in a
prioritized backlog
New stories are welcome at any time
User story priorities are determined by the project stakeholders
Level of effort is estimated by the team in arbitrary units of story points
12. What does typical
Agile Software Development
look like?
The highest priority user stories are batched into iterations (or sprints) of two
to four weeks
Teams collaborate to execute the entire lifecycle within an iteration (“Done
done”)
Design, coding, integration, test, release
Iteration Planning to bring developers and stakeholders together
Accept Completed Stories
Agree on Stories for the Next Iteration
Team Retrospective
Daily stand-up meetings (or scrums) to share plans and resolve blocks
15. Step Back to the Fundamental Goals
Regulatory agencies and Agile proponents both value
high-quality software that meets the end user’s
needs
SAFE and EFFECTIVE
So, how can the practices by aligned?
16. Medical Device Manufacturers
and the FDA
both wanted Guidance on
Appling Agile Practices to Medical Device
Software
AAMI Medical Device Software Committee approved the creation
of an Agile Software Task Group in 2009
Joint Chairs – Bakul Patel (FDA) and Patty Krantz (Medtronic)
Goal: How to best align agile concepts and practices with the
regulatory requirements for medical device software
19. Key Conclusions and Recommendations
from AAMI TIR45:2012
Agile can bring value to medical device software
Agile can be adapted to the unique needs of medical
device software
Apply the values of Agile in a way that enhances a robust
quality management system
Apply the practices of Agile within the context of an
established quality management system
22. Individuals and interactions
over processes and tools
Effective processes and tools will help a good team perform even better, but no amount of processes and
tools will help a poor team perform well.
Documented processes and supportive tools bring discipline to a development process by codifying
procedures and behaviors that have been deemed important.
But, problems can occur if the team does not feel responsibility for the process, resulting in processes that are
misunderstood or ignored, or if the documented processes do not support execution realities, resulting in the “two sets
of books” mentality where the things we say do not match what we actually do.
AGILE imposes a different focus on discipline: the discipline of an interactive team of individuals who are
aligned on shared goals, shared values, and shared principles. Following the principles of “inspect and
adapt” and “visibility,” an AGILE team is obligated to regularly ask itself how the processes and practices
are working and then make improvements.
But problems can occur if the team does not accept responsibility for its processes and practices, if the team is not
sufficiently trained on fundamental concepts for software development processes and the requirements of a quality
management system, or if schedule pressures discourage the team from committing the necessary time to the inspect-
and-adapt principle.
Apply the discipline of a clear and sufficient documented process to establish the rigor necessary for
medical device software. Apply the discipline of agile to adapt a rigorous process to the team’s context and
focus on continuous improvement.
Both perspectives place value on a development team that takes ownership of the software it creates and the
processes and practices used to create it
23. Working software
over comprehensive documentation
Working software is the ultimate deliverable, the best indicator of progress and the best
indicator that the needs of the customer are being satisfied.
Regulations and standards require certain kinds of documentation to demonstrate that a
robust process has been followed to develop a safe and effective product: that is a given
Effective documentation can help a software team produce a safe and effective product
Agile concepts should be applied to ensure that valuable documentation
is produced and wasteful documentation is eliminated
“If it isn’t documented, it didn’t happen.” is a useful notion to highlight the importance of
producing an audit trail, but over-emphasizing it can lead to a checklist mentality where
documentation is produced simply to satisfy some real or imagined requirement while
providing no value
Development team should consider what is valuable to them and what is valuable to
regulators. The most valuable documentation will satisfy both
24. Customer collaboration
over contract negotiation
Although contracts are useful, they cannot by themselves ensure that a
development team will produce a product that satisfies the customer
Understanding user needs and the intended use of the software product, and
ensuring that the software is designed and validated for that use, is a vital
element of creating a safe and effective product.
An emphasis on customer collaboration means that the software’s definition will
evolve over time
For most development projects, the full definition cannot be known upfront and
the most responsible course of action is to capture the definition, requirements,
and specifications that are known in advance and then to fully elaborate them
over the whole lifecycle of the project.
It is important for the project’s development plan to explain how the definition of
the software will emerge and how artifacts will be created to demonstrate how
that definition emerges in a controlled way.
25. Responding to change
over following a plan
Change is inevitable in new product development and should be embraced as
a good and useful thing
Clear and sufficient plans help establish reasonable expectations, set the
project up for success, and provide a means of control, but no amount of
detail in a plan can predict and control the dynamic nature of new product
development
Agile puts tremendous emphasis on planning, with varying levels of planning
happening every day during a project
Plans must not be seen as rigid mandates for how work must be done, but
instead should be used as effective guidance that can be adapted as work
proceeds
It is important to define the planning activities that occur and the artifacts
that are generated in order to be able to demonstrate them to a regulator
(2 minutes) Present the Agile Manifesto(5 minutes) Backdrop to the manifesto (waterfall, etc.)
(3 minutes) Initial reaction from medical device community
(5 minutes) Core description of what agile software development means
(5 minutes) Evolution of AAMI TIR45:2012, incl. FDA involvement and recognition as a consensus standard
(10 minutes) Walk through TIR recommendations, how to apply them, real life anecdotes
Second class status to ‘process’, ‘documentation’, ‘contracts’, and ‘plans’?
On the face of it, this can’t be relevant to medical device development with an emphasis on design controls and 62304?
What were the bad practices that led to the manifesto
What were the bad practices that led to the manifesto
What were the bad practices that led to the manifesto
What were the bad practices that led to the manifesto
There are many more features of agile development teams, but this should cover the high points for this audience.
There are many more features of agile development teams, but this should cover the high points for this audience.
The development process depicted in the example is a traditional waterfall model. The design proceeds in a logical sequence of phases or stages. Basically, requirements are developed, and a device is designed to meet those requirements. The design is then evaluated, transferred to production, and the device is manufactured. In practice, feedback paths would be required between each phase of the process and previous phases, representing the iterative nature of product development. However, this detail has been omitted from the figure to make the influence of the design controls on the design process more distinct.
Puts TIR45 on the same standing as 14971, 60601-1, 62304, and 62366
It’s no longer a question of ‘Will the FDA accept this?’
The FDA now advocates in favor of agile development practices to develop safer products that meet user needs.