Seapine Software: State of Medical Device Development 2014 · development with new methods and tools. To help manage these challenges, medical device companies have found new ways

2014 State of Medical Device Development | seapine.com 1

State of Medical Device Development

2014

http://www.seapine.com


Executive SummaryThe demand for smarter, safer, more connected medical devices has introduced new complexities to the development process. As medical device manufacturers race to bring innovative new products to market, they must overcome the challenges these complexities create—managing product risk, documenting proof of compliance with industry regulations, and streamlining development with new methods and tools.

To help manage these challenges, medical device companies have found new ways to improve the product development process. These process improvements—and the challenges that drive them—are what we sought to understand with the 2014 State of Medical Device Development Survey.

Managing risk is the first key challenge survey respondents identified. In order to be effective, risk mitigation artifacts must be visible to everyone involved in the development



and testing of the product. Teams have found that storing risk documentation on a shared drive or in a document control system often results in key team members seeing it too late in the process. This causes expensive rework that could have been avoided if the risk artifacts were more visible.

Working with documents is the second key challenge identified by respondents. Teams are losing valuable time as they struggle to manually manage the reports, matrices, and other documentation needed to facilitate development and provide proof of regulatory compliance. This time could be better spent refining the product and getting it to market faster, but outdated tools have most teams hobbled with manual documentation.

It should be no surprise, then, that the final key challenge identified is overcoming barriers to improvement. Despite a clear need to get better development lifecycle management solutions in place, companies are restricted by tight budgets, validation overhead, and bureaucracy.

Key ChallengesThe 2014 State of Medical Device Development Survey identified three overall challenge areas:

1. Managing Risk: Teams struggle to make risk more visible across the development lifecycle.

2. Working with Documents: Teams spend far too much time managing, linking, and reviewing documents.

3. Overcoming Barriers to Improvement: Budget, validation overhead, and bureaucracy prevent companies from making needed improvements.



About the SurveyThe 2014 State of Medical Device Development Survey was conducted from June 1, 2014 through August 31, 2014 and sponsored by Seapine Software. We gathered input from almost 500 individuals working at all levels within the medical device industry. The majority of respondents were working on Class II or Class III devices, with a smaller number also involved in the development of Class I devices.

Altitude: The survey respondents represent all levels within medical device development companies.

What is

your current level within the organization?

Professionals35%

Management29%

Senior Executive36%



How long have you been

working in the life sciences

Industry?

10+ Years61%

5-10 Years18%

Less Than5 Years21%

Experience: Although all levels of experience in the industry were represented, this year’s survey attracted more experienced practitioners.



Role: Respondents were concentrated in the engineering and quality groups, with additional input from the research side.

Other2%

Regulatory &Quality

32% Engineering57%

Research9%

What is

your current role within the organization?



Key Challenge: Managing RiskEnsuring that risk analysis and mitigation work is incorporated into the final device is important to making certain a device is safe to use. This year’s survey shows that more teams are using document control systems (EDCM, QMS, etc.) instead of storing their risk management documents in a shared network. The motivation for this move is often compliance-related (ISO 14971, IEC 62304, etc.) or because the team needs to make risk more visible.

Unfortunately, visibility into risk is still limited in a document control system. To comply with increasingly stringent regulatory requirements, leading companies are implementing next generation techniques and tools to improve risk visibility. These purpose-built solutions enable teams to conduct risk analysis and mitigation within a comprehensive, end-to-end, wholly traceable system, capturing and recording all relevant data throughout development.

How do you

manage risk identification, analysis, and mitigation?

Documents Under

Document Control

43%

Documentson Shared Network47%

Broken Down into Individual Risk Artifacts in a Commercial Software Tool10%



Methods UsedThe top three methods used for mitigating risk in this year’s survey were Failure Mode Effects Analysis (FMEA), risk management files, and Root Cause Analysis (RCA). Nearly 70% of respondents said they also use Corrective and Preventative Action (CAPA) as part of their quality management system. No distinction was made between reactive and proactive methods.

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Nothing Formal

FMEA

FTA

HAZOP

RCA

FMECA

Safety Assurance Cases

HACCP

PHA

RCCA

Risk Management Files

What types of risk

management methods do

you use?



Tracking RiskSurvey results show two-thirds of teams start tracking risk before device development work is started. This helps teams avoid costly rework by identifying potential risks early in the development process. The danger is that all of that risk information can get lost or forgotten once the actual development work begins, if it’s locked away in a document control system.

When do you start

documenting risk?

Concept Feasibility Development Verification

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

31% 35% 7%27%Phase



Increasing VisibilityTracking risk alongside design and testing assets in an integrated product development solution not only keeps risk visible to the team throughout development, it also improves visibility into risk assessment and mitigation efforts across the entire organization. This heightened visibility helps ensure risk management work done early in the process is not lost or forgotten once development begins.

New regulatory requirements and an increased focus on the cost of care are challenging device manufacturers to improve visibility across the development lifecycle in order to meet aggressive deadlines and prove a device’s safety and efficacy. We asked respondents to identify the “top 3” areas where they need improved visibility.



What are the top

three pieces of information

you wish you had better visibility

into?

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Related Defects

Project Status

Gap Analysis

Risk Controls

User Needs

Change Management

Related Requirements

Trace Structure

Impact Analysis

Top 3 Elements Needed for a Successful ProjectThe “top 3” here are critical for a successful project:

1. Project status keeps the project’s key requirements visible, helping teams meetdeadlines and stay within budget.

2. Effective impact analysis of proposed changes ensures changes do not derail theproject schedule. This is almost impossible to do with a document-centric approach.

3. Risk controls ensure the product is safe to use and are also an important componentof regulatory approval.



Key Challenge: Working with DocumentsGetting new devices to market depends on proving regulatory compliance, and that depends on having the proper documentation. For the third year in a row, documenting work and reviewing that documentation are cited as the top two time-consuming aspects of the product development process.

What are your

most time-consuming

tasks?

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Objective Evidence

Documenting Work

Organizing Work

Communication & Collaboration

Prioritizing Work

Researching Related Items

Data Analysis

Seeking Approvals

Linking Related Items

Updating Multiple Systems

Establishing Risk Controls

Reviewing Documentation



Because of the challenges involved in developing today’s devices, many companies have adopted product development software solutions that automate the creation and maintenance of the necessary traceability documentation. These solutions are often part of a comprehensive, end-to-end system that captures and records all relevant data, from design to development to service and support.

By adopting these purpose-built solutions, companies can increase team productivity and product quality while mitigating risk and proving regulatory compliance. These solutions track the individual artifacts created during the development process, giving teams better visibility and control than a document-centric solution can offer.



Between 2011 and 2013, we saw a large jump in the number of companies adopting these solutions to help them better manage their product development. This year’s results show the adoption of product development software solutions has stagnated a bit.

Use of artifact-centric vs. document-

centric approach

Artifact-Centric Document-Centric

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

2011

2013

2014



The reason for this slowdown isn’t clear, but when we analyzed it demographically, we noticed a higher adoption rate among respondents who are newer to the industry. It could be that professionals with more experience are accustomed to “the way we’ve always done it” and are hesitant to change, or that newer professionals have more knowledge about the latest technologies and methods being practiced with success in other industries.

25

0

50

75

100

Document-Centric

1-5 Years Experience 5-10 Years Experience 10+ Years Experience

Artifact-Centric

The use of document-centric tools is

high among more experienced professionals



A document-centric approach is any approach based on managing large documents in their entirety. Document-centric approaches limit reusability, traceability, visibility, and team-based work. These documents are usually worked on as a single unit, rather than breaking out each artifact into its own document. To avoid a substantial amount of manual merging and potential error, only one person can update the document at a time—lengthening review cycles and requiring traceability to be managed separately. Ultimately, it becomes increasingly difficult to manage, transfer, and reuse key data as portions of documents evolve into other work or artifacts.

An artifact-centric approach focuses on working with individual project assets or artifacts. These artifacts can be sent out for review to only the people responsible for each piece, with a commercial tool centralizing their changes. There’s no need to merge changes because user A will see user B’s change in real time and can adjust their updates and feedback accordingly. Artifact-centric approaches allow for much better data, risk, gap, and impact analyses, and reviewed artifacts can still be compiled into a final document. With commercial software tools assisting in artifact management, users can focus on tasks instead of constantly maintaining documents. An artifact-centric approach can also easily support various development methodologies—spiral, iterative, parallel, Agile, and other alternatives to Waterfall methods.

DOCUMENT-CENTRIC VS. ARTIFACT-CENTRIC



Managing RequirementsWhen a product development effort reaches design control, the need increases to move from working in Excel and Word to a more specialized solution. This year’s survey results show teams continuing to move into specialized commercial tools to manage the creation, review, and implementation of product requirements during design control.

When you factor in the complexity of today’s products and the number of teams required to bring a product to market, it’s not surprising that more are choosing to move away from documents and into commercial tools built specifically to manage the product development lifecycle.

How do you manage

requirements?

Commercial Tool20%

Documents Under

Document Control

32%

Documents on Shared Network40%

Other8%



How do you

verify approved or changed

requirements?

Verifying ChangeIn 2011, only 32% of respondents were using electronic signatures in their approval and audit processes. Last year, that number grew to 40%, and this year e-signature usage equals the use of manual signatures to verify requirements changes.

We expect this trend to continue as more regulatory teams embrace electronic signatures and adopt tools to support this functionality.

Electronic Signatures Manual Signatures

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

2011

2013

2014 50% 50%

40% 60%

32% 68%



Managing Quality and TestingAlthough document control is still more common for managing risk and design artifacts, respondents have broadly adopted commercial tools for managing testing. The industry appears near the tipping point, where commercial solutions will soon become the most common method for managing the testing effort.

How do you manage your

testing efforts?SomewhatElectronic (Word or Excel documents managed in directories)26%

Manual (Printed documents)20%

CompletelyElectronic (Software

designed to manage test

cases)25%

Electronic (Static

documents in a document or

quality control system)

21%

Do Not Manage Test Cases

8%



As with requirement changes, more teams are taking advantage of technology to electronically sign test cases and results. We expect this trend to continue as tool adoption increases.

How do you verify completed

test cases?

Electronic Signatures Manual Signatures

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

2013

2014 39% 61%

35% 65%



Improving TraceabilityTraceability not only connects the entire product development process, but also is key to gaining regulatory approval for medical devices. Teams using a document-centric approach spend an inordinate amount of time digging through documents to ensure accurate traceability from design through code and testing. Teams are slowly finding ways to reduce the time spent on traceability, but almost half still waste a day’s effort or more each time they need to update the trace matrix.

How long does

it take to update the traceability

matrix?25

0

50

75

100

2011 2013 2014

Minutes Hours Days Weeks Don’t Know



This isn’t too surprising when you consider the number of artifacts and work items involved—especially when all of these different assets are buried in documents scattered across the company.

What development artifacts are

included in your traceability

matrix?

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

MarketingReqs

ProductReqs

RiskArtifacts

Test Cases

Test Runs

Defects

SystemSpecs

DevelopmentTasks

Feature Requests

User Stories

Code

UserReqs



Adding to the problem is the fact that more teams are creating the trace matrix early, so it will be more complete and accurate. These teams are likely balancing that benefit with the reality that creating the trace matrix early also means much more time spent updating it.

At what

point in the project is the traceability

matrix created?

During Concept/Feasibility Start of Design Start of Verification Right Before

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

19% 43% 13%25%Phase



Key Challenge: Overcoming Barriers to ImprovementMaintaining an effective development process—one that fosters innovation while at the same time ensuring full regulatory compliance—requires a delicate balance of culture, methodology, and technology.

When asked to identify the top three hurdles they faced in trying to improve their development processes, respondents chose budget, validation overhead, and bureaucracy.

What are

the top three issues that prevent you from improving

your product development processes?

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Interpreting Regulatory Guidelines

Budget

ConsensusDecision

Bureaucracy

Lack of Good Existing Processes

Lack of Tools

Integrating Existing Tech Investments

No SupportFrom IT

ValidationOverhead



BudgetBudget is once again the top issue that organizations perceive to be preventing them from improving their product development processes. This should come as no surprise, given the economic issues that continue to challenge the industry. Teams struggle under increasing pressure to reduce costs and get products to market faster, yet they may get pushback from upper management when they request new tools that will help them meet these demands. Fewer companies embrace the “spend money to make money” philosophy, leaving their teams handicapped with outdated development tools.Validation OverheadIt’s interesting to note that the cost and time spent validating new and upgraded systems jumped to second on the list in this year’s results. Only 27% reported it as a top barrier to preventing improvement last year. This year, nearly half say it is keeping them from improving their product development processes. BureaucracyManagers were the only respondents for whom bureaucracy remained the second biggest barrier to improvement, but it was still high on the list for non-management respondents. It’s clear that companies need to simplify the complicated rules and processes that stand in the way of improvements their development processes.



Agile’s Place in Medical Device DevelopmentIn January 2013, FDA officially acknowledged Agile by adding AAMI TIR45:2012, Guidance on the Use of Agile Practices in the Development of Medical Device Software to its list of recognized standards. To gauge Agile’s popularity in the industry, we asked respondents if they were using Agile or some hybrid methodology that incorporates Agile concepts.

Almost half of the respondents said they are either successfully using Agile or hybrid methods or are planning to adopt them within the next 12 months. Another third of respondents are working to understand how or if Agile practices can help their development efforts.

Are you using Agile

or some hybrid methodology?

Don’t Believe Agile Fits With Regulatory Requirements 22%

Working to Understand How Agile Fits with Regulatory Requirements30%

Electronic (Static

documents management in

a document or quality control

system)21%

Planning To Adopt Agile Or

Hybrid Practices In The Next 12 Months

28%

Successfully Using Agile

Or Hybrid Practices

20%


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Among Seapine’s medical device customers, we most often see a hybrid approach. The software teams tend to incorporate some Agile practices into their processes to iterate fast and respond to change, while retaining all of the traceability and documentation required to get a product through regulatory approvals. In many cases it’s a more process-heavy version of Agile than is typical in other industries.

The Path Forward: Collaboration, Visibility, TraceabilityNew regulatory requirements and an increased focus on the cost of care are challenging device manufacturers to improve visibility into the entire development lifecycle in order to meet aggressive deadlines and prove a device’s safety and efficacy.

Regulatory compliance is key to driving new products to market, and the keys to compliance are managing risk and providing the documentation to back it up. Because of the challenges involved in regulatory documentation, generating the required traceability documents should be an automated process. Companies should look to a purpose-built software solution that incorporates this functionality—preferably one that conforms to their business needs and processes.



The solution needs to be more than a document control system, however. It should be part of an integrated system that increases visibility of all development artifacts, particularly those related to risk. The right software solutions can help support better methods and practices, improve team collaboration, and remove much of the administrative burden associated with regulatory compliance.


About Seapine SoftwareWith over 8,500 customers worldwide, Seapine Software, Inc., is the leading provider of quality-centric product development solutions. Headquartered in Cincinnati, Ohio, with offices in Europe, Asia-Pacific, and Africa, Seapine’s development solutions help organizations ensure the consistent release of high quality products, while providing traceability, metrics and reporting, and compliance.

Learn more at seapine.com.

www.seapine.com