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1 State of Medical Device Development State of Medical Device Development seapine.com 1

2 Executive Summary The 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 2014 State of Medical Device Development seapine.com 2

3 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 This time could be better spent refining the product and getting it to market faster, but outdated tools have most teams hobbled with manual documentation. Key Challenges The 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. 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 State of Medical Device Development seapine.com 3

4 About the Survey The 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? Professionals 35% Senior Executive 36% Management 29% 2014 State of Medical Device Development seapine.com 4

5 Experience: Although all levels of experience in the industry were represented, this year s survey attracted more experienced practitioners. Less Than 5 Years 21% How long have you been working in the life sciences Industry? 10+ Years 61% 5-10 Years 18% 2014 State of Medical Device Development seapine.com 5

6 Role: Respondents were concentrated in the engineering and quality groups, with additional input from the research side. Other 2% Research 9% What is your current role within the organization? Regulatory & Quality 32% Engineering 57% 2014 State of Medical Device Development seapine.com 6

7 Key Challenge: Managing Risk Ensuring 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. Documents Under Document Control 43% How do you manage risk identification, analysis, and mitigation? Broken Down into Individual Risk Artifacts in a Commercial Software Tool 10% Documents on Shared Network 47% 2014 State of Medical Device Development seapine.com 7

8 Methods Used The 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. FMEA Risk Management Files RCA What types of risk management methods do you use? FTA PHA FMECA Nothing Formal HACCP RCCA HAZOP Safety Assurance Cases 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2014 State of Medical Device Development seapine.com 8

9 Tracking Risk Survey 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? Phase 31% 35% 27% 7% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Concept Feasibility Development Verification 2014 State of Medical Device Development seapine.com 9

10 Increasing Visibility Tracking 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 State of Medical Device Development seapine.com 10

11 Top 3 Elements Needed for a Successful Project The top 3 here are critical for a successful project: 1. Project status keeps the project s key requirements visible, helping teams meet deadlines and stay within budget. 2. Effective impact analysis of proposed changes ensures changes do not derail the project 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 component of regulatory approval. Project Status What are the top three pieces of information you wish you had better visibility into? Impact Analysis Risk Controls Gap Analysis Related Requirements User Needs Related Defects Change Management Trace Structure 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2014 State of Medical Device Development seapine.com 11

12 Key Challenge: Working with Documents Getting 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 timeconsuming aspects of the product development process. Documenting Work Reviewing Documentation Communication & Collaboration What are your most timeconsuming tasks? Organizing Work Data Analysis Prioritizing Work Objective Evidence Researching Related Items Seeking Approvals Linking Related Items Updating Multiple Systems Establishing Risk Controls 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2014 State of Medical Device Development seapine.com 12

13 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 State of Medical Device Development seapine.com 13

14 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 artifactcentric vs. documentcentric approach % 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Artifact-Centric Document-Centric 2014 State of Medical Device Development seapine.com 14

15 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. 100 The use of documentcentric tools is high among more experienced professionals Years Experience 5-10 Years Experience 10+ Years Experience Document-Centric Artifact-Centric 2014 State of Medical Device Development seapine.com 15

16 DOCUMENT-CENTRIC VS. ARTIFACT-CENTRIC 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 State of Medical Device Development seapine.com 16

17 Managing Requirements When 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. Other 8% How do you manage requirements? Commercial Tool 20% Documents on Shared Network 40% Documents Under Document Control 32% 2014 State of Medical Device Development seapine.com 17

18 Verifying Change In 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. How do you verify approved or changed requirements? % 50% % 60% % 68% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Electronic Signatures Manual Signatures 2014 State of Medical Device Development seapine.com 18

19 Managing Quality and Testing Although 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? Completely Electronic (Software designed to manage test cases) 25% Do Not Manage Test Cases 8% Manual (Printed documents) 20% Electronic (Static documents in a document or quality control system) Somewhat Electronic (Word or Excel documents managed in directories) 26% 21% 2014 State of Medical Device Development seapine.com 19

20 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? % 61% % 65% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Electronic Signatures Manual Signatures 2014 State of Medical Device Development seapine.com 20

21 Improving Traceability Traceability not only connects the entire product development process, but also is key to gaining regulatory approval for medical devices. Teams using a documentcentric 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. 100 How long does it take to update the traceability matrix? Minutes Hours Days Weeks Don t Know State of Medical Device Development seapine.com 21

22 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. Product Reqs User Reqs Test Cases Risk Artifacts System Specs Test Runs What development artifacts are included in your traceability matrix? Marketing Reqs Defects Development Tasks Feature Requests User Stories Code 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2014 State of Medical Device Development seapine.com 22

23 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? Phase 19% 43% 25% 13% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% During Concept/Feasibility Start of Design Start of Verification Right Before 2014 State of Medical Device Development seapine.com 23

24 Key Challenge: Overcoming Barriers to Improvement Maintaining 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. Budget What are the top three issues that prevent you from improving your product development processes? Validation Overhead Bureaucracy Consensus Decision Integrating Existing Tech Investments Lack of Good Existing Processes Interpreting Regulatory Guidelines Lack of Tools No Support From IT 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2014 State of Medical Device Development seapine.com 24

25 Budget Budget 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 Overhead It 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. Bureaucracy Managers 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 State of Medical Device Development seapine.com 25

26 Agile s Place in Medical Device Development In 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? Planning To Adopt Agile Or Hybrid Practices In The Next 12 Months 28% Successfully Using Agile Or Hybrid Practices 20% Working to Understand How Agile Fits with Regulatory Requirements 30% Don t Believe Agile Fits With Regulatory Requirements 22% Electroni (Stati document management in a document o quality contro system 21% 2014 State of Medical Device Development seapine.com 26

27 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, Traceability New 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 State of Medical Device Development seapine.com 27

28 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 State of Medical Device Development seapine.com 28

29 About Seapine Software With 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.

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