Managing compliance for medical devices with IBM Engineering Lifecycle Management

Today’s regulatory landscape

01

Today’s regulatory landscape

Explore the challenges facing the medical devices industry.

5 min read

Smarter connected products

02

Smarter connected products

Focus on optimizing the development processes.

5 min read

Industry challenges

03

Industry challenges

What are the challenges for complex development for medical devices?

3 min read

Regulations impacting the medical device industry

04

Regulations impacting the medical device industry

Accelerate time to market despite growing regulations.

10 min read

IBM Engineering solutions can help

05

IBM Engineering solutions can help

Transform your development processes with end-to-end lifecycle management.

4 min read

Smarter Requirements Management

06

Smarter Requirements Management

Improve productivity, minimize risk, and reduce costs.

3 min read

Integrated change and configuration management

07

Integrated change and configuration management

A collaborative task environment that enables agility of workflows.

3 min read

Quality management, design and development solutions

08

Quality management, design and development solutions

Model resilient architectures and reach your compliance goals.

4 min read

Reimagine your development process with IBM Engineering

09

Reimagine your development process with IBM Engineering

Reach your compliance goals with best-in-class tools and processes.

2 min read

Managing compliance for medical devices with IBM Engineering Lifecycle Management

01

5 min read

Today’s regulatory landscape

Explore the challenges facing the medical devices industry.

Person with wearable medical device attached to knee looking at data on phone

Today’s medical device industry is faced with rising pressures to combat market uncertainties amidst increasing product complexity and moving-target regulatory mandates. To remain viable and competitive, businesses must balance rapid innovation with compliance guidelines that dictate safety standards. The need to accelerate innovation and embrace technology advancements in biologics, advanced sensors, or increased reliance on software, all while maintaining compliance, requires significant process and development lifecycle transformations. There are shared concerns that the processes dictated by broad and evolving regulatory and governing bodies (such as FDA, GMP, EU MDR, IVDR, etc.) negatively impact time to market and development time.

The United States Food and Drug Administration (FDA) regulates over $2.5 trillion USD in products including, but not limited to:1

  • Pharmaceuticals for human and animal use
  • Biological and related products, including vaccines and therapeutics
  • Electronic medical devices
  • Radiation emitting devices

The FDA monitors the production, import, transport, storage and sale of these products in the United States. Compliance with FDA regulations is a market requirement. Failure to comply can be very costly, including financial penalties, recalls, criminal penalties, and loss of market share.

The latest European Union Medical Device Regulations (MDR) and In Vitro Diagnostic Medical Device Regulations (IVDR) are changing the European market since they impact both new and existing products. The conformity assessment for CE marking has proven more time consuming given stricter regulations.

Solving the quality and speed dilemma unquestionably becomes a very critical factor.

Achieving development lifecycle efficiencies and injecting more agile development practices while maintaining compliance is often reported as a foremost concern. When provided with high-quality development and design control processes, and sufficient tools to support and automate these processes, time to market can actually be decreased, resulting in higher-quality products and services. This article provides an overview of the current challenges facing the medical device industry and explores how IBM Engineering Lifecycle Management can help.

IBM Engineering products for systems and software engineering can assist with reaching compliance goals through integration, collaboration, automation and reporting. The solutions support the creation and management of lifecycle work products necessary to fulfill FDA and EU regulations and guidelines. These solutions provide a core set of best-in-class tools and processes for software and product development teams, facilitating engineering collaboration with an unprecedented level of transparency of project progress, control of artifacts, traceability with audit trails, task management and change control.

IBM Engineering Lifecycle Management (ELM) addresses the FDA-identified lack of design controls as one of the major causes of device recalls by:

  • Maintaining design control specifications in a central, automated repository using customizable document templates
  • Facilitating design control process models, attributes and reports
  • Maintaining up-to-date traceability matrices
  • Executing change impact analysis and capturing design history
  • Managing compliance

 

1 Office of the Commissioner, FDA at a Glance (PDF, 1.3 MB), FDA.GOV, August, 2018

02

5 min read

Smarter connected products

Focus on optimizing the development processes.

Person sitting at table in kitchen uses medical device on finger

Today’s healthcare field is quickly evolving and increasingly becoming more networked and interconnected. When developing cutting-edge medical devices, teams have an increasing reliance on accurate data, global supplier networks, and complex systems of systems.

To meet innovation goals and bring new products to market faster, companies must focus on optimizing and automating development processes. As today’s healthcare providers, payers, and consumers move toward electronic records management and overall smarter healthcare, the medical devices used to implement our care must not only communicate data to doctors, nurses and clinicians but may also transmit data for more accurate billing and more comprehensive patient data management.

Medical devices are becoming more sophisticated and complex with more real-time data available to clinicians in order to make better diagnoses and care decisions. Many devices record and transmit patient and device data back to physicians and device manufacturers to aid in patient care, and to help influence the development of new products and features in order to repurpose or modernize existing product lines. These devices are becoming more and more customized and offer variances that meet hospital, emergency response and field needs. Data is continually analyzed to make diagnoses early and to predict outcomes.

Healthcare reform will potentially impel tens of millions of citizens who do not currently have healthcare insurance into the healthcare network, driving demand for access to treatments such as drugs, biologics and increasing medical device usage. The push toward electronic medical records and mandates such as the Health Insurance Portability and Accountability Act (HIPAA) and massive changes in electronic data interchange and International Classification of Diseases (ICD) codes will drive the modernization of core applications and systems. The cost of reform and compliance will drive technology investments to modernize legacy systems and develop new business models.

What is the common driver to delivering smarter devices, drugs and biologics, or modern health maintenance networks? Software. Software is the key factor for injecting new features, functions, and providing protocols for networking and building system user interfaces. Software-driven capabilities are driving innovations in modern portal-based payer/provider/consumer networks, complex data management systems, intelligent medical devices, and pioneering drug and biologics research and development. Software is the key to competitive advantage.

Today, the med tech industry is also implementing AI to derive insights from connected products. Medical device companies are exploring how to deliver better and faster diagnostics through machine learning to optimize treatment.

All innovations have validity, provided they comply with regulations and adhere to safety, security and reliability standards.

In 2019, a total of 49 device recalls were issued by FDA for Class III devices alone. The medical device industry has extensive regulatory and compliance demands, which creates challenges in compliance-driven development. IBM Engineering Lifecycle Management can help address these challenges.

03

3 min read

Industry challenges

What are the challenges for complex development for medical devices?

Medical device manufacturers must manage complex system requirements and maintain extreme quality control processes across their portfolios of products. Developers and engineering teams must base their strategies on real data to classify risks, ensure proper mitigation of hazards, and ensure quality through rigorous testing.

Success today depends on the ability to deliver the right features and functions faster, while increasing productivity, reducing costs, and ensuring quality across the development cycle. All of these challenges are compounded by the need to ensure adherence to stringent regulatory mandates.

How are medical device developers staying competitive?

Percentage of sales due to new products or new system releases, return on market investment, strategic planning operating budget per revenue, return on total assets. The introduction of EU MDR, IVDR in 2017.

Number of products per platform, amount of software per platform, cost for each new product or system, cost of modernization. With the EU MDR, a product and platform strategy is required. This may cause some product portfolios to divest since cost of compliance will increase dramatically.

Improving time to market, increasing market share, achieving price premiums and return on investment for development.

Time from development to maturity, new product or system success rate, cost per engineering change, time and cost for conceptual mockups.

Meet mandates for classification and management of risks and hazards (Failure Modes and Effects Analysis [FMEA], Fault Tree Analysis [FTA]).

FDA, number of notices of violations from regulatory agencies, dollar value of potential legal liabilities, patents, corrective and preventive actions (CAPA).

04

10 min read

Regulations impacting the medical device industry

Accelerate time to market despite growing regulations.

The medical device industry is faced with ever-increasing regulation and oversight of the design control process with an increased focus on device recalls and unintended consequences of improper use. In the FDA’s own words, “Since 1984, FDA has identified lack of design controls as one of the major causes of device recalls. The intrinsic quality of devices, including their safety and effectiveness, is established during the design phase.”

In response to device safety concerns, the FDA created the Quality Systems Regulations (QSR CFR 21 part 820) to ensure that products meet requirements and specifications and that current good manufacturing practices are followed in the development of devices.

Some of the key elements of the QSR that are of concern to device development organizations include:

  • Strict design control measures
  • Use of tools to improve the development process
  • Separate definition and traceability of user requirements to design input
  • Separation of validation (user and patient needs are met) from verification procedures and record-keeping (specified requirements are met)
  • Software validation requirements that apply to software components in medical devices, to software that is itself a medical device, and to software used in the production of the device or in implementation of the device manufacturer’s quality system

Most regulatory standards provide a framework, but leave it up to device developers to implement quality development procedures. It is the responsibility of manufacturers to establish requirements for each type or family of devices that will result in products that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements.

Lack of design controls is one of the major reasons for device recalls and audit violations.

In order to lower development risks, costs and reduce time to market, teams must adhere to a development process that defines requirements, identifies risk, manages change and facilitates simulations and tests well in advance of implementation. Expenditures skyrocket when deficiencies are discovered late in the development lifecycle.

Following a design control process that is repeatable, scalable, and automated can provide better project visibility and predictability while lowering overall costs, reducing product development time, and helping to navigate regulatory acceptance into the market.

The EU MDR

The EU MDR requires an enterprise-wide approach with a multi-disciplinary and cross-functional governance program, which affects certain key areas in product development and manufacturing. For instance, manufacturers are required to monitor the safety profile of their products, not only involving safety, security and reliability assessment in product development, but also through the implementation of a post-market surveillance plan. This strengthens the controls around transparency and traceability within the whole supply chain.

Establishing, implementing, documenting and maintaining a Quality Management System (QMS) is another mandate for medical device manufacturers. It is recommended that makers of these devices follow ISO 13485 as an internationally harmonized standard for designing a QMS for medical device development. The regulation (MDR, IVDR), when compared with the older version (MDD, IVDD), requires increased controls over supplier and outsourcing activities and a risk-based approach to QMS activities as well as the implementation of risk management processes throughout the product lifecycle. In addition to having a post-market surveillance plan to monitor the safety profile, strengthened supply chain controls, and QMS overhaul, medical device manufacturers are also required to understand the new clinical evaluation process and clinical evidence requirements. These regulations impact the development of new products as well as current products on the market since the certification process of current products will not be exempt from the new clinical evidence requirements.

Clinical Evaluation Reports (CER) are critical compliance deliverables that record proper clinical evaluations. However, there is still some lack of clarity in the exact requirements of clinical evaluation processes and CER – and their best practices. It‘s crucial for medical device manufacturers to provide traceability between product requirements at the intended use environment, original design, and verification and validation procedures both for analytical and clinical validation.

Automation of the capture, recording and traceability between these items not only cuts the time spent focused on regulatory compliance, but can also speed development time.

Automation helps medical device manufacturers deal with the difficulties introduced via the clinical evaluation requirements. Adherence to a process that identifies requirements before implementation and then controls and manages requirement changes throughout the design process is more efficient and requires fewer design iterations. When the requirements are identified, progress metrics and projection of completion dates are more objective and quantitative. Even when new requirements are identified mid-design or mid-implementation, the impact on the overall schedule is more quantitatively predictable when the requirements are properly captured and dependencies between requirements are maintained. Clients are often skeptical that following such a process can reduce time to market, but a good design control process followed by change and design management allows problems to be identified earlier in the process while they are smaller, simpler, faster, and cheaper to fix.

05

4 min read

IBM Engineering solutions can help

Transform your development processes with end-to-end lifecycle management

IBM Engineering Lifecycle Management (ELM) best-in-class tooling helps organizations develop corporate standard processes that provide efficiencies of scale. Developers can know what to expect and easily develop compliant solutions incorporated with design control processes in line with FDA QMS requirements, the EU MDR, and satisfy Good Manufacturing Practice (GMP) guidelines. The IBM Engineering solutions for systems and software engineering support collaborative tasks and linking of the lifecycle work products. Compliance can be simplified with automated capture of design history, lifecycle traceability and quality management processes required to manage compliance.

The ELM suite offers integrated, end-to-end traceability and fault and failure analysis that can improve processes, automate document generation, manage compliance to regulatory standards like IEC 62304, IEC 61508, 21 CFR 820.30, 21 CFR 11, ISO 13485 and ISO 14971.

Demonstrating compliance means control and documentation of the typical development tasks such as requirements gathering, analysis, system design, detailed design, verification and validation, risk analysis, project management and reporting. The IBM Engineering tools offer visibility, control and automation. It’s an open, proven, complete and modular solution comprised of a comprehensive set of tools built around best practices. IBM Engineering solutions offer all the tools that teams need to successfully define requirements, model, build, test, and deploy products.

Without integrations across the systems delivery lifecycle, systems and software teams are left to operate in silos. When silos form, product delivery effectiveness suffers. In order to deliver smarter products that respond to changing market needs, it’s necessary to allow engineering teams to collaborate across globally dispersed teams to efficiently manage all the lifecycle work products.

The IBM ELM tools provide an integrated and collaborative environment for requirements analysis, architecture management, and configuration management for teams of software and systems engineers. The ELM bundle includes:

 

06

3 min read

Smarter Requirements Management

Improve productivity, minimize risk and reduce costs

Requirements management products help define and manage requirements to reduce rework, demonstrate compliance and minimize costs and risks.

Person uses tablet while leaning against brick wall

IBM Engineering tools help address concerns related to product innovation such as improving time to market and achieving ROIs. Through requirements traceability, development teams can trace requirements to (and from) system requirements to test and risk analysis results, facilitating more accurate analysis and demonstration of compliance. In a recent industry study, organizations surveyed incurred a cost of as much as 60 percent on time and budget when they used poor requirements practices.1 When requirements are defined and managed properly, project overruns can be significantly reduced.

IBM Engineering Requirements Management DOORS Next is a market-leading requirements management solution that can help reduce costs, increase efficiency and improve quality by managing requirements collection, control, communication, collaboration and verification. The use of its integrated requirements design environment can help manage the traceability of your compliance and regulatory needs throughout the design and implementation lifecycle.

IBM Engineering DOORS software design control templates built against FDA design control inspectional techniques can jumpstart projects subject to FDA regulations. Engineering DOORS software attributes can be used to properly classify and manage risks and hazards as required by the FDA. Engineering DOORS software maintains requirement and specification records of the design process which can demonstrate how your design and development plans are met by verification and validation plans and how risks can be mitigated.

Using DOORS Next, traceability reports and matrices can be produced in a fraction of the time that it would take to produce them manually. Most importantly, Engineering DOORS software maintains a full audit trail on all changes: what was and what is, user ID and date and time stamps of changes so that the design history file is created automatically as users go about their work of entering data and creating links. Electronic sign off is also available.

1 Michael Krigsman, Study: 68 percent of IT projects fail, ZDNet, January, 2009

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3 min read

Integrated change and configuration management

A collaborative task environment that enables agility of workflows

Person on virtual conference call on computer

Integrated change and configuration control and automated workflows enable real-time, cross-team communication and collaboration for rapid response to change. collaborative, productive, and transparent. IBM Engineering Workflow Management is designed for global and distributed teams, serving as the collaborative engine of the ELM bundle, coordinating engineering tasks and workflows, all governed by a customizable team workflow process. Requirements can be linked to work items, which helps both developers and stakeholders review requirements linked to specific work items. The work items can be requirements change requests, implementation tasks, defects, or other standard or custom work items.

FDA regulations require the identification of major development tasks, deliverables for each task, and individual or organizational responsibilities (staff and resources) for completing each task. IBM Engineering Workflow Management integrates stakeholders, project leads, and systems engineers to facilitate compliance to FDA requirements for a quality design control process. It offers the collaborative task environment and automated change control process required by medical device developers and life sciences teams to manage FDA quality regulations and adhere to design control change management guidelines. Project dashboards improve project tracking through transparency and reporting of team status and project health. Dashboards present live project and plan information in tabular or graphical form, further facilitating control over the development process while also providing flexibility and agility in team workflows. The team build component features a standardized and controlled build process to build awareness, control, and traceability for everyone involved. Teams can also enjoy improved configuration management to control product content as required by the FDA.

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4 min read

Quality management, design and development solutions

Model resilient architectures and reach your compliance goals

Woman with robotic arm and hand holding baby

Design and development solutions

Design and development tools help model, design, and build resilient architectures for today’s most innovative products, software and systems of systems. IBM Engineering Systems Design Rhapsody offers capabilities for modeling system and software requirements, as well as developing and delivering the software components. It provides an easy-to-use yet rigorous environment for the creation, management and execution of both SysML and UML models.

IBM Engineering Systems Design Rhapsody is a visual development environment for systems engineers and software developers creating real-time or embedded systems and software. This proven tool helps diverse teams collaborate to understand and elaborate requirements, and abstract complexity visually using industry-standard languages. Medical device engineers can work in a collaborative development environment with simulation for early requirements, architecture and behavioral validation, fostering a better understanding of complex requirements and trade-off analysis of complex systems.

The intent of the FDA quality system requirements is that the product’s conceptual description be elaborated, expanded, and transformed into a complete set of design input requirements which are written to an engineering level of detail. FDA regulations require procedures for the formal review and documentation of the evolution of the design and identification of concerns and potential design issues. IBM Engineering Rhapsody helps capture design evolution, and its powerful simulation abilities support design reviews while helping in the early identification and capture of potential design issues.

Quality management solutions

Quality management solutions help teams advance productivity and quality across the entire lifecycle. IBM Engineering Test Management provides a collaborative environment for test planning, construction, and execution, supporting continuous testing as well as test management of system validation and acceptance testing. FDA regulations are very much focused on verification and validation (V&V) requiring a defined and controlled process is followed. V&V planning, reviews, methods and results all must be documented and linked to changes or corrective actions that result from testing. IBM Engineering Test Management links test artifacts across the lifecycle so that requirements, change requests, development tasks and development artifacts may all be traced. Teams can also facilitate effective workflow control, tracking and traceability features for test and verification. The dashboards allow testers to review the systems quality metrics and project status, which may include tasks assigned in Workflow Management, requirements defined in DOORS Next or software integration builds ready to be tested.

09

2 min read

Reimagine your development process with IBM Engineering

Reach your compliance goals with best-in-class tools and processes.

The IBM Engineering tools for systems and software engineering can assist with reaching compliance goals through integration, collaboration, automation and reporting. These solutions support the creation and management of lifecycle work products necessary to fulfill FDA or EU regulations as well as safety and quality standards like IEC 62304, ISO 13485, ISO 14971. The ELM suite of products provides a core set of best-in-class tools and processes for systems and software engineering teams, facilitating engineering collaboration with an unprecedented high level of transparency of project progress, control of artifacts, traceability with audit trails, task management and change control.

Operating theater for surgery

The IBM ELM products help address the FDA identified lack of design controls as one of the major causes of device recalls by:

  • Maintaining design control specifications in a central, automated repository
  • Providing design control specifications using customizable document templates
  • Facilitating the design control process models, attributes and reports
  • Maintaining up-to-date traceability matrices
  • Executing change impact analysis and capturing design history
  • Managing compliance

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