Welcome to the 2018 State of Medical Device Development.
We’re excited to bring you the results of the 2018 State of Medical Device Development Survey.
Nearly 200 medical device developers responded with insight into how they’re developing today. In this report, you’ll learn about technology development trends and challenges facing the industry. And you’ll get insight into where the medical device industry is going in 2018.
We hope this information will help you manage your development lifecycles and ship quality medical devices faster.
Thank you to everyone who participated in the survey!
Tim Russell
Chief Product Officer, Perforce
Table of Contents
Trends in Medical Device Development
There are three key trends in medical device development today.
- More medical device developers use specialized tools to manage their product lifecycles.
- Agile adoption is on the rise.
- Internet of Things is impacting medical device design.
How Manufacturers Manage the Medical Device Lifecycle
Medical device developers are using specialized tools at a higher rate than in previous years.
In 2016, just 33 percent used specialized tools to handle development artifacts. These artifacts include requirements, risks, test cases, and issues.
This year, 40 percent are using a specialized toolset.
However, 60 percent of those surveyed still use a fairly manual process to manage change, versioning, reviews, and approvals.
Given that most medical device developers have manual processes, it’s not a surprise that a majority rely on Microsoft Office to help manage their lifecycles.
- 63 percent use Microsoft Word to manage requirements.
- 65 percent use Microsoft Excel to manage test cases.
- 53 percent use Microsoft Excel to manage and track issues.
But Microsoft Office isn’t the only tool being used to manage medical device lifecycles. Most survey responders use Microsoft Office in combination with other tools, including Jira and Helix ALM.
It’s also not a surprise that these manual processes lead to time-consuming tasks for development teams. Many people stated that documenting work and reviewing documentation are the most time-consuming tasks they work on.
The three biggest areas are:
- Documenting work and reviewing documentation (33 percent). An example of this is creating a traceability matrix using Microsoft Excel.
- Organizing and prioritizing work (14 percent). An example of this is using a combination of Jira tasks and Microsoft Word requirement documents to manage work.
- Communicating with team members (13 percent). An example of this is using email (e.g., Microsoft Outlook) without direct visibility into project status.
Microsoft Office is likely to remain critical in the medical device industry. However, there’s room for improvement in the way that medical device developers use Microsoft Office.
Methodologies Used for Medical Device Development
Across industries, development teams favor Agile development for faster, high-quality releases. This trend holds true in the medical device industry, too. Agile and hybrid Agile adoptions are on the rise.
However, medical device developers have more regulatory constraints. They need documentation to prove compliance. This slows the adoption of Agile in the medical device industry.
Of those surveyed, 38 percent have changed their development process in the past 12 months. Those who made a switch have gone from primarily using Waterfall to primarily using Agile.
Of those surveyed, 49 percent have tried adopting Agile for medical device development. Of those, most were successful (36 percent) or somewhat successful (61 percent).
Most who failed to adopt Agile struggled with lack of internal knowledge (33 percent). By comparison, in previous years, lack of management support was a bigger problem.
This shift indicates increased support from management in going Agile. The bigger difficulty is in successfully implementing Agile.
The Impact of Other Technology on Medical Devices
Technology is in a state of constant integration. There’s a call for connected devices across industries. And there’s an expectation for devices to wirelessly connect to other systems. Medical devices aren’t immune to this.
The Internet of Things (IoT) has been around for years, and it’s not going anywhere. More devices are capable of connecting with other devices and systems, giving rise to an interconnected ecosystem.
A majority of medical device developers are impacted by IoT. They are either actively working on IoT (22 percent), have another team working on IoT (five percent), or will be including IoT in future plans (31 percent).
Many medical device developers can connect their devices to other systems. These are primarily smartphones, tablets, or laptops or wearables. And most respondents connect to multiple types of systems.
Challenges in Medical Device Development
Compliance regulations change. The auditors come calling. Risks come up — and need to be dealt with.
Despite these challenges, medical device developers are expected to deliver safe, quality products on time.
Here’s how those who took the survey manage these challenges every day.
Proving Compliance and Passing Audits
For the medical device industry, proving compliance is a top priority. Medical device manufacturers can’t go to market without approval from regulatory bodies (e.g., FDA and ISO).
Of those involved in compliance, most struggle with risk analysis (24 percent). This is a bigger area of difficulty for developers, compared to previous years.
Others struggle with delivering objective evidence (17 percent) and demonstrating traceability (13 percent).
These struggles aren’t a surprise. Most medical device developers are using manual processes and Microsoft Office to manage requirements, tests, and issues. This can lead to time constraints and inaccuracies when it comes to proving compliance.
Getting requirements from Microsoft Word, test cases from Microsoft Excel, and bugs from Jira creates extra work — and adds to the challenge of proving compliance.
Medical device developers who struggle to prove compliance also lack confidence in their ability to pass FDA audits.
Of those surveyed:
- Only 46 percent were confident that they could pass an FDA audit.
- 41 percent were somewhat confident.
- 13 percent were not at all confident.
This is likely due to their difficulties in proving compliance in the first place.
To be successful in the medical device industry, developers need total confidence in their ability to pass audits.
Managing Risk
Risk analysis was the biggest area of difficulty in proving compliance. Managing risk is a big challenge across medical device development, as well.
Risk and Traceability
The vast majority — 85 percent — of those surveyed find traceability valuable for more than just compliance. This is up significantly compared to previous years. In 2015, just 61 percent used traceability for more than compliance.
In this year’s survey, 25 percent find value in using traceability to manage risk. After all, it’s easier to identify and mitigate risk using traceability. And 24 percent use traceability to manage change. That’s because traceability helps developers understand the impact of change before it happens. That, in turn, helps manage risk.
Other key areas where developers use traceability include decision-making (20 percent) and impact analysis (18 percent).
Risk and Visibility
Medical device developers need more visibility to manage risk and deliver quality products.
Medical device developers want visibility into:
- Clinical or other research data (18 percent)
- User needs (13 percent)
- Project status (9 percent)
Getting visibility would help them meet market needs and stay on track. A centralized, integrated toolset would make it easier to get this visibility.
Risk and the Cloud
Cloud-based software has grown in prominence over the past decade. Medical device developers have gained confidence in using cloud-based software. It can help distributed development teams collaborate and develop more efficiently.
Today, 79 percent of those surveyed are confident or somewhat confident.
Those who lack confidence in cloud-based software are primarily concerned with security or privacy (42 percent). Data breaches and hacks occur frequently, and medical device developers aren’t immune to cybersecurity risk.
Other developers are concerned with IP protection (20 percent) and performance (16 percent).
The Future of Medical Device Development
The future of medical device development is in innovating, keeping up with trends, and overcoming challenges.
To remain competitive, medical device developers will need to innovate — which will prove difficult. Of those surveyed, 57 percent cited simpler and centralized regulatory standards as the biggest opportunity to innovate in the medical device industry.
Unfortunately, this is not likely to change. Industry regulations are likely to remain complex. Regulatory bodies (including the FDA and ISO) are unlikely to unify their regulations.
Achieving regulatory compliance will remain critical to the success of medical device developers.
There are some feasible opportunities for medical device developers to innovate today.
Sixteen percent want better development technology and tools. Adding a centralized application lifecycle management tool, such as Helix ALM, will help developers improve productivity and product quality.
Efficiently managing the development lifecycle will become more important — especially as medical device developers strive to adopt Agile.
Fifteen percent want more funding options. Unlocking additional funding could help medical device developers in their quest for better technology and tools. Medical device makers might find some relief in legislation passed in early 2018. This delayed the Affordable Care Act’s medical device tax for another two years.
There’s room for improvement in the medical device industry. However, as medical device developers embrace better tools, they’ll be able to prove compliance, manage risk, and innovate more.
Who We Surveyed
We surveyed nearly 200 medical device professionals in March 2018.
Who Participated
Everyone from industry veterans (10+ years) in the upper tiers of management to professionals with less than a year of experience working in development participated.
What They Develop
Most of those who participated produce medical devices. Others create products like laboratory instruments and pharmaceutical drugs. An array of medical device classes were represented in the survey.
Resources
If you’re looking to improve medical device development, start with the following resources.
Proving Compliance
Case Study: How to Achieve Medical Device Compliance: Fractyl’s Story
Case Study: IMT Leverages Helix ALM to Centralize Requirements and Reduce Risk
White Paper: The Impact of 21 CFR Part 11 on Product Development
White Paper: Agile in FDA Regulated Environments
Managing Risk
White Paper: Exposing Risk Throughout Your Product Development Lifecycle
White Paper: How to Simplify Risk Management With Automated Traceability
Webinar: How to Manage Risk Using Traceability
Adopting Agile
White Paper: Agile in FDA Regulated Environments
See How Helix ALM Will Help
Helix ALM helps medical device developers manage their projects, prove compliance, and adopt Agile every day. Sign up for a live demonstration of Helix ALM to learn how.