By Nico Kruger, Perforce Software
Perforce Software recently conducted its annual survey of medical device professionals, and the results provide insight into how device development has changed in the past 12 months, current views on market challenges and trends, and the potential implications of these findings.
Perhaps the survey findings’ standout message is that device developers continue to struggle to innovate within an increasingly regulated landscape. This challenge is coupled with a desire for more unified, simplified regulation and standards and — of course — a desire for more investment. While little of this news may seem surprising there, the survey results also reveal some encouraging signs.
However, for many, manual processes remain a hindrance to productivity, as is lack of visibility within development projects. Worryingly, even fewer respondents are confident about passing an FDA audit compared to last year. In parallel, 2020’s EU Medical Device Regulation is now on people’s radars.
First, though, it is important to note who responded to the study and what they were asked: 267 medical device professionals worldwide — ranging from industry veterans and top management to development professionals with less than one year of experience — were surveyed in February 2019. The respondents also represented a variety of device types (hardware, software, or both) and classes (I,II, III, IV, De Novo), 58 percent were in the US, 42 percent were spread worldwide.
Survey respondents were asked a variety of questions in the following categories: challenges they encounter in development; tools and methodologies they are using; regulations they are watching; technology trends on their radars; and what they believe will boost innovation.
Low Productivity and Visibility
Time-wasting activities continue to be a frustration. When asked what activity they would like to spend less time on, respondents gave “unnecessary meetings” top billing. This answer was closely followed by documenting work and reading documentation (45 percent) and tracking down project status (41 percent).
Professionals also noted a strong desire for more visibility into design control phase activities (44 percent). Combined, these sets of results point towards the need for more transparency, visibility, and collaboration across teams, plus more context throughout a project’s design phase.
To support that cultural approach, it is important to look at the types of tools and processes people use. For instance, while the use of specialized medical device development tools, such as application lifecycle management (ALM) software, has increased by 25 percent in the past three years, almost 60 percent of respondents still manage work with a combination of Word documents and spreadsheets.
While these traditional office applications have their place, they were never designed to handle the complexity development teams face when managing requirements, test cases, and issues. This is why many modern medical device development teams have started using tools that give them the visibility and cross-functional collaboration they need, while still providing the traceability data that the business needs for documentation and compliance purposes.
Quality and Compliance
Lack of information seems to be contributing to respondents’ reduced confidence that they could pass an FDA audit: 38 percent have such confidence this year, compared to 46 percent in 2018. Of course, compliance is never easy and there are always going to be multiple factors involved. However, the biggest three compliance challenges cited by respondents were documentation, objective evidence, and risk and hazard analysis — followed by traceability, design history files, and audit trails.
Apart from FDA regulations, when asked what was on their regulatory radar for the next year, almost 50 percent of respondents cited the European Medical Device Regulation (MDR). Revisions to ISO 14971, which covers documented narrative of product lifecycle, and ISO 13485, which covers quality systems, both featured highly in medical device professionals’ responses.
Medical device companies have recently started to embrace Agile as a development methodology. However, like other inherently risk-averse markets — particularly those focused on functional safety — the medical device industry has shied away from ‘pure’ Agile. Instead, hybrid Agile is clearly the stand-out trend.
Nearly 40 percent of respondents who changed methods in the past year have chosen the hybrid route. Ranked second and third are Scrum and scaled Agile (such as SaFe), respectively. This is a massive swing from just one year ago, when Stage-Gate — an established Waterfall methodology — still led the pack, with hybrid Agile representing just a very small percentage.
This shows just how fast the industry can change when the impetus is present. Encouragingly, 75 percent of those who changed methodology in the past 12 months were satisfied with the results. Those who were not satisfied with the transition to Agile — in whatever form — said resistance to change (19 percent), inadequate tools (also 19 percent) and lack of internal knowledge (14 percent) were the main culprits.
The 267 medical device professionals also were asked about their knowledge, interest, or involvement in some of the biggest development trends and technologies predicted to shape the industry. Around two-thirds of the organizations who responded already are working, to some degree, on connected device (IoT) projects. That ratio is also similar for organizations’ adoption of artificial intelligence (AI) and machine learning (ML). Wearables, not surprisingly, led the way as the biggest trend on people’s radars for the next year, with 40 percent of respondents citing product-specific wearables and 25 percent mentioning consumer wearables.
A general trend in other safety-critical markets, such as automotive and aerospace, is the use of coding standards to ensure safe, high-quality codes, as well as to support adherence to compliance requirements. However, compared to other markets, awareness and adoption seems low, with 73 percent of respondents either not using a coding standard themselves, or not aware whether the team is applying one. This could be an area for the industry to explore further, particularly as the need to balance time-to-market with safety, security, and compliance is only going to become more pressing.
Respondents also were asked more generally about what they feel would contribute most to product innovation in the medical device industry and the feedback was loud and clear: half of respondents called for either simplified regulation or unified international standards; and around one-third would like more investment — whether that’s through greater R&D spend, more technology tools to help them do their jobs better, or greater funding options.
These final takeaways underline what we all know: while the medical device market continues to make great strides forward, there is still much that its participants want to see improved.
Readers can view the survey on which this report is based here. Additionally, you can view the article based on the 2018 survey here.
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 familiarity with key standards.