Name: Patterns of Agile Success for Medical Device Development
Start: 2021-09-09T13:00:00Z
End: 2021-09-09T14:01:29.000Z
Location: BrightTALK
Rating: 5

Our regular webinars feature Intland's domain-expert partners, invited professionals from leading digital product development companies, and Intland's own experts. These live sessions (as well as their on-demand recordings) cover a variety of topics related to software-heavy product development in safety- or mission-critical industries. Join our webinars for cutting-edge insights & best practices from industry leaders. Find out how leading innovators are cutting product development time and costs, and how they use Application Lifecycle Management to gain a competitive edge.

Abstract
In this webinar hosted by Ansys, we present the use case of Veoneer, an American-Swedish provider of automotive technology. Veoneer develops innovative complex solutions for ADAS and Autonomous Driving with requirements often subject to change until the SOP. High complexity combined with various technologies developed and integrated across 11 countries worldwide requires a high level of agility. Veoneer’s mission is to “build trust” into products with a unified approach to safety.

To achieve this goal, Veoneer improves the usage and the templates of Ansys medini and Intland’s codebeamer. Aligned internal processes and knowledge sharing from lessons learnt worldwide help Veoneer employees in improving their standard tool ecosystem.

Join our webinar to learn more about
- Performing agile and collaborative safety analysis within a global organization
- Integrating medini analyze within Veoneer’s ecosystem
- Introducing efficient medini data structures and library concepts
- Working with medini throughout multiple systems of hardware and software safety analysis
- Improving global data consistency with seamless integration using medini and codebeamer

Creating Collaboration and Safety Across Globally Distributed Teams

Increasing product sophistication and digital transformation drives the demand for new tools and processes to support development and QA teams’ needs for agile, best-of-breed tools. Product innovation goes beyond efficiency and needs insights, and interoperability to connect the dots with informed decision making. Modernizing dated and legacy tools that no longer serve the transparency and traceability needs is among the first steps that organizations can take to build high quality products faster.

In this webinar experts from OpsHub and Intland Software will talk about the key considerations for modernizing your quality management tools.

Agenda
- Business imperative for quality management modernization
- Tooling strategies: best-of-breed vs integrated toolsets
- Significance of active & historical data
- Pros and cons of tool adoption strategies: rip and replace vs coexist
- Migration approaches: Big bang vs agile migration
- Best practices/strategy for application modernization

Mark Schultz is Vice President of Sales at OpsHub. He has extensive experience in aligning with Customers and Partners to achieve business objectives. Prior to OpsHub, Mark worked at VersionOne (now Digital.ai) for 10 years. During this time, Mark resold OpsHub integration solutions and worked with multiple digital transformation partners to help enterprises scale Agile and DevOps practices. Mark works with Intland from a Business Development and Sales perspective, which includes ensuring customer success.

OpsHub is the leading provider of integration and migration solutions for the ALM, CRM, and DevOps toolchains. OpsHub enables modern software teams to innovate by empowering enterprises to modernize and unify their toolchain and reap actionable insights from disparate tools. OpsHub flagship products for migration, integration and insights help teams to leverage the best tool for a given task, collaborate seamlessly and unlock the full potential of their data.

Key considerations in Quality Tool Modernization

Agile approaches offer many benefits for product development in the regulated domain of healthcare technology. What specific and proven best practices contribute to the success of Agile? What important experiences do healthcare companies report?

This webinar presents case studies and experience reports from the agile development of MedTech products. It shows possible practical solutions to overcome the perceived incompatibility between agile methods and regulatory constraints. Participants will receive orientation and evidence-based guidance to make their agile product development a success.

The webinar’s agenda:
 - What benefits do healthcare companies experience when moving to agile product development?
 - What are the key agile success strategies of organizations in the regulated MedTech domain?
 - How can agile organizations overcome regulatory challenges and manage product success?
 
Our webinar is intended for:
 Project Managers and Team Leaders, Product Quality and Test Engineers, Heads of Testing & QA teams, 
 Embedded Software Developers, Business Analysts, Regulatory Compliance Analysts

Presenter details:
Dr. Andreas Birk is the founder and principal consultant of Software.Process.Management. He helps organizations optimally design and improve their software development processes. His focus areas are software product management, Agile development, and tool-based requirements management.

Patterns of Agile Success in Medical Device Development

Medical device development can benefit much from agile approaches to software and product development. However, regulatory constraints and other characteristics of health tech development necessitate the use of advanced Agile workflows and practices.

This webinar presents and explains specific Agile practices, i.e., methods, workflows, templates etc, that are particularly important for medical device development. Examples are: using a Definition of Done for managing regulatory constraints, establishing traceability between agile work items, and building compliance incrementally.

The webinar’s agenda:
 - What are the challenges of applying Agile in medical device development?
 - Important Agile practices for medical device development explained
 - Successfully establishing new Agile practices in MedTech environments

Our webinar is intended for:
Project Managers and Team Leaders, Product Quality and Test Engineers, Heads of Testing & QA teams, Embedded Software Developers, Business Analysts, Regulatory Compliance Analysts

Presenter details:

Dr. Andreas Birk is the founder and principal consultant of Software.Process.Management. He helps organizations optimally design and improve their software development processes. His focus areas are software product management, Agile development, and tool-based requirements management.

Agile Best Practices for Medical Device Development

In the development of modern technology products, efficient and accurate requirements management is crucial – and so is maintaining lifecycle-wide traceability. But achieving these in a fast-paced environment with a heterogeneous tooling landscape is a challenge, especially if Agile is the method of choice. Teams still struggling with outdated legacy solutions such as MS Word & Excel or IBM Rational DOORS find that these tools are no longer able to provide future-proof support for their needs.

Watch this webinar recording to learn how a specialized digital Application Lifecycle Management platform like codebeamer can help your team achieve transparency, traceability, and efficiency in end-to-end product requirements management. This webinar also covers a demonstration of requirements engineering best practices as implemented in codebeamer. Watch the recording to understand how to achieve maturity in digital requirements management using a cutting-edge ALM tool!

End-to-End Product Requirements Management with codebeamer

The challenges of developing the mobility experiences of tomorrow and those of innovating future-oriented digital health products are not entirely dissimilar. In fact, teams experience very similar challenges presented by the complexity of developing future-proof technology products.

In this Intland Connect 2021 online session, two leading companies operating at the forefront of innovation in two very different fields share their insights on the challenges and solutions of developing the technology products of the future!

CARIAD is an automotive software and technology company that bundles together the software competencies of the Volkswagen Group. The primary goal of the company is to transform the car into a software and IT-driven device. They do this by delivering a unified software platform and tech stack for all of VW’s brands.

Roche is the frontrunner in personalized healthcare, with a combined strength in pharma and diagnostics. The company is the global leader in cancer research and treatment, and a leading provider of in-vitro diagnostics around the world.

Watch this recording for insights on:

The challenges of being both fast and flexible in tech product innovation
The concept and practice of building an adaptable template for domain-specific teams to accelerate product development
Scaling unified innovation best practices across projects

Cross-Industry ALM – Commonalities between Automotive & MedTech

The more innovative your business, the more it is exposed to the effects of digital transformation. One great example is that of ABB Robotics, a global player in robotics and machine automation.

In this Intland Connect 2021 online session, ABB’s Digital Project Manager Anita Nemes-Solymosi shares insights on how Engineering Lifecycle Management helped sharpen the company’s focus on product quality and customer experience. In her talk, she covers how codebeamer X has helped ABB bring project management to the next level.

Watch this recording to understand:

the main roadblocks to digital innovation and a detailed digitalization roadmap applicable to any organization
why ABB Robotics has chosen to implement ELM software
how the company has been able to create a customer-centric quality organization using codebeamer X
the benefits and value they realized by modernizing their processes

Benefits and Value of Digital Tools for Modern Project Management

Rescya is an innovative provider of advanced drug delivery technologies, focusing on user-friendly soft mist inhaler devices. As a company operating at the intersection of pharmaceuticals and medical devices, Resyca is in a unique position with a range of regulatory and innovation challenges. To overcome these, Resyca built their complete Requirements Management, Quality Management System, and Device Document Management System in Intland Software’s codebeamer X.

In this Intland Connect 2021 online session, Resyca’s experts provide insights into how this health tech innovator manages the complete quality and development lifecycle of pharma products within codebeamer X in compliance with ISO 13485.

Watch this recording to understand how Resyca:

Has built a system to manage development and regulatory aspects in health tech innovation
Manages QMS and GxP documentation for both medical device and combination products
Digitally manages the generation of device documentation for regulatory submissions

Development of Drug-Device Combination Products with codebeamer X

Disruptive trends in the digital world present companies with the challenge of ever-increasing complexity in their software-driven products. However, instead of being able to focus on the enablers of tomorrow’s world, they are struggling with yesterday’s disablers: traditional development methods, redundant data, process and system breaks in their PLM and ALM systems.

A crucial success factor is holistic systems lifecycle management. Instead of thinking in silos of “mechanics” and “software”, a new approach is needed to integrate the delivery of all the components of a modern digital product.

Join our webinar with BHC to learn how PLM, ALM, and SysLM approaches may be interwoven for a holistic System Lifecycle Management approach for software-driven products.

The topics we will discuss:
A short overview of the concepts of PLM, ALM and SysLM
Modern challenges in the development of complex technology products
Synchronisation as a key factor
Speaker Information:
Julian Weyer
Senior PLM Consultant, BHC GmbH

Julian Weyer, Senior Consultant at PROSTEP subsidiary BHC, focuses on end-to-end PLM solutions for the digitalized world. As an expert on variant management, product configuration and systems engineering, he is also co-author of BHC’s whitepaper trilogy “Software-driven products”, addressing of what is needed from capable PLM backbones regarding the engineering of complex mechatronic systems.

Unifying Software/Hardware Lifecycle Management for Software-driven Products

Medical device development with its regulatory requirements is often viewed unsuited for Agile methods. However, such perceived challenges can be overcome, unlocking Agile’s potential to bring important benefits to the development of medical devices.

This presentation introduces specific Agile practices that are particularly important for medical device development. Examples are: Definition of Done, traceability between agile work items, and building compliance incrementally.

The presentation explains how these practices can be introduced in your development environment, and how they can be supported effectively through state-of-the-art tool infrastructures. The recommendations are substantiated by experience reports from leading healthcare organizations.

What to expect:
Importance and challenges of Agile in MedTech
Approaches and best practices for Agile in MedTech
Solution elements of advanced tool support
The webinar’s agenda:
Challenges of Agile in MedTech
Best Practices for Agile in MedTech
Definition of Done
Building up Compliance Incrementally
Requirements Traceability
Hybrid Development
Experience & Recommendations
Our webinar is intended for:
Project Managers and Team Leaders, Product Quality and Test Engineers, Heads of Testing & QA teams, Embedded Software Developers, Business Analysts, Regulatory Compliance Analysts

Presenter:
Dr. Andreas Birk is the founder and principal consultant of Software.Process.Management. He helps organizations optimally design and improve their software development processes. His focus areas are software product management, Agile development, and tool-based requirements management.

Agile in MedTech: Essential Best Practices, and How to Support Them

1st rerun, with a new QA session.
Medical device development with its regulatory requirements is often viewed unsuited for Agile methods. There does seem to be a natural tension between commonplace Agile practices and regulatory compliance requirements in MedTech. However, these challenges can be overcome, unlocking Agile’s potential to bring important benefits to the development of medical devices.

This webinar highlights key characteristics of medical device development that must be considered to guide the successful implementation of Agile. During this session, we’ll present important strategies that support MedTech organizations on their journeys to Agile, helping them make the most of Agile’s enormous potential!

The webinar’s agenda:
Does Agile contradict regulated product development?
Advantages of Agile for medical device development
Challenges of Agile adoption in MedTech environments
Agile success strategies for medical device development
Our webinar is intended for:
Project Managers and Team Leaders, Product Quality and Test Engineers, Heads of Testing & QA teams, Embedded Software Developers, Business Analysts, Regulatory Compliance Analysts

Presenter
Dr. Andreas Birk is the founder and principal consultant of Software.Process.Management. He helps organizations optimally design and improve their software development processes. His focus areas are software product management, Agile development, and tool-based requirements management.

Approaches to Agile in Medical Device Development

Software is on the rise. It is the number one topic in the development of new functions within the Automotive industry. The development of software is a constant challenge for OEMs and Tier 1 suppliers. What seems trivial at first glance turns out to be a much greater challenge than many people expect. Falling productivity, increasing communication, declining quality, constantly rising development costs and project delays are omnipresent. Learning from successful companies and industry thought leaders can highly assist in managing complex challenges.

Join McKinsey’s Senior expert, Georg Doll to learn more about the growing challenges of complexity currently experienced by developers of digital mobility technology. Find out how successful organizations have tackled these challenges with a holistic approach. 

The webinar’s agenda:
-Future trends of automotive industry, the reasons why software is on the rise
-The implications of growing software trends, deepdive into complexity and challenges
-How to manage complexity: what are the key success factors that differentiate successful companies?

When Things Get Complex: Challenges, Complex Systems, and Where to Focus

In the complex development of automotive technology, ensuring functional safety compliance is an ongoing effort. Veoneer, this provider of automotive technology, implemented a digital system with custom configurations to accelerate compliance with ASPICE and ISO 26262.
Learn more about the challenges Veoneer faced with their DOORS-based toolset, and how integrated tooling enabled them to automate processes to cut development time and costs. Join Veoneer’s expert Larry Spino as he shares insights on unifying & optimizing the automotive development toolchain!
 
The webinar’s agenda:
-Introduction to Veooner & the company’s use case
-Issues caused by tool incompatibility: Veoneer's experiences
-Solution: Veoneer’s toolset for traceability & compliance

Veoneer: Best Practices for Traceability and ASPICE Compliance

International analysts Kisaco Research have recently released their latest Leadership Chart report on Engineering Application Lifecycle Management Solutions for 2020-21. Comparing ALM vendors, the report ranks Intland Software as a Leader when compared to IBM, Polarion, Inflectra, and Jama Software.

Join our Experts Talk webinar, a discussion between Laszlo Piroska (Head of Department, Robert Bosch Engineering and Business Solutions Private Limited, India) and the author of the report, Chief Analyst Michael Azoff. In this session we will be discussing the report’s ALM evaluation criteria, the future of Application Lifecycle Management, and how leveraging cloud-enabled solutions in high-risk product development can help companies control their Total Cost of ALM Ownership and accelerate ROI.

The webinar's agenda:
-The role of ALM in enabling risk management in regulated product development
-Analyst view: evolution of the ALM market
-Kisaco KLC report ALM evaluation criteria

How ALM in High-risk Industries Makes the Difference Between Success and Failure

Unifying the numerous complex stages of product development is a vital challenge for innovators of medical technology. An integrated approach to MedTech product delivery is the key to navigating traceability, risk management, and quality control in a way that supports regulatory compliance and high product quality.

Watch this on-demand Experts Talk webinar with Szabolcs Agai, Intland’s Functional Safety Expert and Quality Consultant. Learn more about the best practices of implementing a fully integrated delivery process from product specification through engineering, software design, and quality documentation all the way to successful compliance audits.

Watch this practical-minded on-demand webinar to learn more about using Intland’s tools and Medical Software Engineering Template to unify and streamline your medical device delivery lifecycle in a traceable manner.

Agenda:

In this on-demand webinar, we cover the topics of:

-Adopting an integrated and traceability-focused approach to medtech product development
-Tracing requirements and other artifacts through each stage of product delivery
-Best practices of tying in quality engineering with product development every step of the way
-Navigating quality management as per ISO 13485 and relevant standards

Integrated MedTech Development from Requirements to Quality Documentation

Intland’s new Avionics DO-178C Template helps aviation product innovators get up and running with their development projects faster and easier than ever before. With built-in domain knowledge, predefined work items & processes, and best practices, the Template supports compliance with DO-178C out of the box.

Join this webinar to explore our new DO-178C Template and understand how it could help your organization accelerate DO-178C compliance.

The session will cover topics including:

- Gapless traceability: a core pillar of DO-178C
- Responding to challenges as new entrants to the industry: Lifecycle and SW Planning Process checklists
- Minimize risks: custom workflows that boost DO-178C Compliance
- Maximize effectiveness: built-in and automated configuration management activities

Our webinar is intended for:

Heads of Design Organizations in Aviation Development, Aviation Systems Development Professionals, Aviation System Engineers, Aviation Product Development Managers, Business Analysts

Avionics Template: Expedite DO-178C Compliance with codebeamer X

Aviation has come a long way since the Wright Brothers. New challenges and opportunities like UAVs, green aviation, autonomous aviation, urban air mobility, and space tourism require more and more digital expertise. New entrants joining the competition are further increasing market pressure.

For a company to be successful in aviation product development, a perfect understanding of regulations, careful avoidance of common pitfalls, and high effectiveness are crucial. DO-178C is the key to developing modern avionics software. In this webinar, independent Aviation Regulation & Process Consultant Lukas Macisak will share insights on building aviation software with DO-178C in mind.

The session will cover topics including:
- What is the purpose and core pillars of DO-178C?
- What are the biggest challenges for newcomers?
- How to avoid common mistakes, minimize risks, and maximize effectiveness?

Avionics Software Development: Introduction to DO-178C

Watch this on-demand recording of Intland Software’s Roundtable Discussion featuring experts representing innovative medical device companies. Titled Agile in Medical Technology, this discussion covers the challenges and benefits of applying Agile practices in the development of cutting-edge medical technology.

Agile in Medical Technology: a Roundtable Discussion

Agile approaches offer many benefits for product development in the regulated domain of healthcare technology. What specific and proven best practices contribute to the success of Agile? What important experiences do healthcare companies report?

This webinar presents case studies and experience reports from the agile development of MedTech products. It shows possible practical solutions to overcome the perceived incompatibility between agile methods and regulatory constraints. Participants will receive orientation and evidence-based guidance to make their agile product development a success.

Agenda:
-What benefits do healthcare companies experience when moving to agile product development?
-What are the key agile success strategies of organizations in the regulated MedTech domain?
-How can agile organizations overcome regulatory challenges and manage product success?

Patterns of Agile Success for Medical Device Development

Medical Devices

Life Sciences

Health IT

Health Tech

Application Lifecycle Management

Agile

Agile Operations

Application Development

Application Management

Enterprise Applications

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Patterns of Agile Success for Medical Device Development

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