By Nico Krüger, Perforce Software
Perforce recently surveyed around 200 medical device professionals and the results underlined how challenging it can be to balance innovative product design with compliance and risk management. Many respondents expressed doubt they could pass an FDA audit. However, some are facing those challenges head-on by adopting new development processes and technologies that blend automation with traceability and auditability.
Who Answered The Survey
The 200 medical device professionals surveyed are spread all over the world. They ranged from industry veterans, with 10+ years of experience, to individuals who have only been in the industry for a year or so. About 42 percent of respondents are in engineering, 41 percent are in project management, and 17 percent serve in quality assurance.
They represented a variety of markets and disciplines, including device hardware and software, diagnostics, clinical data and studies, laboratory and test instruments, and drug delivery. Over 50 percent of the respondents were involved in Class II devices, over 30 percent were involved in both Class 1 and Class II, and about 17 percent were involved in Class III (de novo).
Respondents were quizzed on a range of topics, including:
We’ll start with that last point, because it relates directly to what is taking up people’s time. While 40 percent of respondents claimed to use specialized software tools, a surprising 60 percent still work with manual processes, with the majority of those being in the Microsoft camp. Over 60 percent of respondents reported using Microsoft Word to manage requirements and test cases, and over 50 percent reported using Microsoft Excel to manage and track issues.
Of all respondents, 33 percent cited documenting and reviewing work as their most time-consuming task. That was followed by organizing and prioritizing work, communicating with other team members, and researching related items.
Of course, no two scenarios are going to be the same. Without speaking to respondents individually, it’s hard to draw cast-iron correlations between reliance on manual processes and time-hungry tasks. Still, it’s fair to say that tools such as spreadsheets, word processing, and email are great at tasks for which they originally were designed. However, they generally are not ideal for providing collaborator visibility, clear review and revision histories, or easy retrieval of information. That matters, because document-based processes can hamper rapid feedback loops and time-to-market.
The challenge is, of course, that documentation is a fundamental part of the compliance process, so medical device professionals cannot abandon these processes altogether. The answer is to devise strategies that create a bridge between documentation and more automated, digital approaches that aid team collaboration, as well as reliable, fast development.
Medical device companies already are creating these bridges — for example, one of the most typical hybrid approaches is integration of Microsoft Office with an application lifecycle management (ALM) tool. This gives development organizations the best of both worlds: the requirements, tests, and issues that development teams need, coupled with the generation of compliant documentation.
ALM tools provide a central place to track product risks, requirements, tests, and change requests, reducing the time it takes to conduct reviews. It makes it easier to manage changes, and ensures the correct version of a requirement is being worked on. It also lets the user know the status of any item at any given time.
Still, Microsoft Word retains its place in this more dynamic environment. Because relevant data can be shared by the ALM tool back to Word, it is simpler to create documentation for both internal and external use. Having a central solution allows the data to be exported in the correct format with the various sections defined as templates. This cuts the task down to minutes, instead of days.
Compliance And Risk
The survey also asked those involved in reporting to FDA or other compliance agencies about their biggest challenges. Risk analysis was reported as the principal challenge by 25 percent of respondents, followed by objective evidence, traceability, design history files, and audit trails. Of those surveyed, only 46 percent were confident they could pass an FDA audit; 13 percent admitted to being not at all confident they’d pass an audit.
This points back to the reliance on manual processes and underlines the fact that many organizations require better traceability to achieve and prove compliance. The main driving force behind the use of traceability and impact analysis is to help identify and reduce risk.
The survey results found that traceability is, in fact, already used by the majority of respondents — and 85 percent say they use it for more than just compliance; 25 percent use it to manage risk, and 25 percent of respondents also use traceability to manage change (for instance, helping developers understand the impact of a change before it happens, which, in turn, aids risk management). About 20 percent of respondents reported using traceability to support impact analysis, and a similar portion of respondents leveraged traceability for decision-making.
This gives us interesting insight: while traceability is being broadly used by the survey respondents, there are still significant concerns around risk and being able to meet industry compliance. So, what can be done to improve the effectiveness of traceability?
There are various options available to help identify and mitigate risk within the engineering lifecycle. But one increasingly popular tool in medtech is a “traceability matrix.” This usually takes the form of a table, and it tracks the relationship between different documents, requirements, and tests.
Not surprisingly, a traceability matrix can require a lot of work to create and maintain, and software tools can make it easier. When a central tool that supports the concept of links and relationships between items is used, it allows the engineering and validation teams to generate the trace matrix on demand, whenever it is needed.
Respondents also were asked about their views on technology trends, including the cloud and the IoT. Most surveyed professionals reported being “confident” or “somewhat confident” in using cloud-based software. Those with reservations about the cloud reported wariness primarily around security and privacy (42 percent), as well as IP protection (20 percent). Security is a multi-faceted challenge. But those organizations with better visibility into the development process will stand a better chance of discovering problems early.
The biggest factor driving many of these teams to use cloud-based technologies for their engineering efforts is cost savings. However medical device teams need to validate the tools they use, per FDA guidelines, and with each update of a tool, the company needs to re-validate it. This adds additional cost and time delay for these teams. So, a good strategy is to use cloud-based solutions that are not upgraded without user consent, making validation a one-time step, rather than an ongoing chore.
More than 50 percent of survey respondents reported that the IoT will impact their businesses in one way or another — be it directly, via a third party, or due to plans to implement the IoT into their businesses in the future. Over 60 percent of respondents reported connecting the medical devices they develop to laptops, tablets, and smartphones; 40 percent reported connecting product-specific wearables (such as sensors). And, over 30 percent of respondents reported connecting Electronic Health Record (EHR) systems.
The same fundamental best practices that already exist in medtech apply to the IoT, just on a larger and more diverse scale. In terms of development processes, that means ensuring that any tool or process choices made today need to be able to scale and adapt — perhaps to support new types of file format, standards, or emerging technologies — in years to come. It is hard to predict the future, so having a robust and flexible foundation is essential.
Again, it is difficult to connect different findings directly. That said, medical device professionals responding to the survey cited greater adoption of Agile product development, as opposed to the Waterfall, hybrid (e.g., Waterfall and Agile), and Spiral methods. Anecdotal evidence suggests that the increasing complexity of product development, plus pressure to get products to market as quickly as possible, is driving Agile adoption.
Of the professionals surveyed, 49 percent use either pure Agile (26 percent) or hybrid Agile (23 percent) product development methodologies, and 97 percent of those respondents say that implementation has been “successful” or “somewhat successful.” Of that group, 49 percent are embracing Agile development processes to speed up product delivery, and 19 percent of those organizations who have embraced Agile reported this was either “successful” or “somewhat successful.”
There also are indications that adopting Agile development is getting more management support than previously. Lack of internal knowledge regarding how to adopt Agile within a regulated environment is the biggest perceived barrier to success, echoing what we hear in other industries. There is widespread need for more focus on internal Agile training (not just how it works, but why it matters), encouraging Agile champions touting the methodology within the company, and communicating successful Agile experiences.
The highly-regulated nature of the medical device industry can make adoption of pure Agile difficult. This is why we are seeing more organizations embrace hybrid Agile processes. Hybrid Agile gives them the flexibility and room for innovation they need, but in a “safe” way.
For the medical device industry to succeed, both hardware and software teams need to work towards a common goal. Software teams often want a more Agile approach. Hardware teams often do not have the same flexibility, due to the nature of manufacturing hardware versus software. The hybrid Agile approach lets both teams work side-by-side within a central solution.
In addition to fostering the right Agile ‘culture,’ software tools that support Agile methodologies may help. However, if there is a hybrid Agile environment, make sure the chosen tool is able to accommodate a mix of methodologies at the same time.
The Future Of Medical Device Development
Finally, we asked our 200 medical device professionals to look at the future and tell us what they think would most contribute to product innovation. Over 30 percent said “streamlined and simplified industry regulation,” and just over 25 percent responded with “unified international standards.”
This brings us back to where we started: medical device development is largely governed by compliance and regulation. These are essential but can hinder creative product development and competition.
That’s why it’s more important today more than ever before to choose the right processes and tools. And it’s just as important to create the right development culture. It’s the only way to achieve that delicate balance between accountability and innovation.
About The Author
Nico Krüger is General Manager (ALM/Hansoft) at Perforce Software. He specializes in technical guidance and product development efficiency for global organizations. With 15 years of software development expertise, Nico helps drive the product strategy of Perforce’s development tools and has extensive experience of working with customers in the medical device community, including familiarization with the key standards involved.