We are living through an era of profound change. Technology is affecting this change in ways unthinkable only a decade ago and none more so than in the medical device industry. A tour of life sciences conferences over the past year revealed a number of technological advances that are now driving a whole new set of trends in project management in order to deliver the next generation of medical devices.

Agile development entails splitting into cross-functional, self-organizing, self-responsible teams, consisting of scrum masters, product owners, and development teams.

Among the most significant developments were wearable health monitoring devices for an aging population, the advent of miniaturization of implantable devices, and connected health — connecting doctors and patients to transmit real-time data. There was an emphasis of preventive care over clinical treatments, and surgeons praised the benefits of telemedicine, which enabled them to perform remote surgeries as far as thousands of miles away. Information technology specialists reiterated the increasingly critical role of electronic health records, and big data was a big topic everywhere.

The rapid integration of nanotechnology, cloud connectivity, smartphone access, and personalized medicine is also shifting the delivery of healthcare. As OEMs address this changing healthcare landscape, they will benefit from following four key project management trends: implementing an agile product development process, taking advantage of the cloud and employee’s personal devices, customizing reports, and modifying the role of their project managers. This article looks at each of the four trends and explores how to use them to address the changing healthcare landscape.

Trend #1: Agile Product Development

The time has come for the medtech industry to move away from old school project management methods. Successful companies will complete projects in an agile way — splitting into cross-functional, self-organizing, self-responsible teams, consisting of scrum masters, product owners, and development teams. Traditional requirements will now be delineated into user stories and burn-down charts, and “show and tells” will be used to report progress.

Be careful, though. Some executives may misinterpret the agile manifesto and may subscribe to a misguided belief that team members stop producing documentation and that scrum is an excuse to do whatever you want. They may feel that the method is too loose to work within tough regulatory controls and that the quality of the delivered product will be jeopardized.

“In a sense, agile is like jazz,” says Frank Balogh, principal agile/organizational coach for AOL Platforms. “It’s like improv in a way. It’s not sheet music.” Balogh says that we now work in a world that asks us to deliver products more quickly than traditional models allow.

But what does that mean for medical device development? Scrum team members will still have to master the technology and know regulatory guidelines such as FDA regulations and IEC standards. Agile practices and more self-directed teams will enable project management teams to develop more visual representations of project information. Regulations and guidelines will be embedded into project management software, keeping team members focused and aware of applicable regulatory information.

BYOD — bring your own device — is a concept that allows employees to use their own computers, smartphones, or other devices for work purposes, enabling project management applications to move from inside the firewall to third-party hosted cloud solutions.

Guidelines are available to help medical OEMs adapt to agile processes. In 2012, the Association for the Advancement of Medical Implementation (AAMI) released TIR45, which guides medical device development companies on how to use agile under stringent quality regulatory processes. TIR45 is a good reference and also aligns with IEC 62304, “Medical device software — Software life cycle processes.”

Expect to see agile practices expand to non-software-based projects. The challenge in adopting an agile approach lies in the organization’s readiness to accept its simplicity. The principles are straightforward, but cultural and behavioral changes often are not. Agile relies heavily on having a good tool for managing workflow, so OEMS will benefit from investing in one that they can customize.

Trend #2: The Cloud and BYOD

Mobile collaboration will be critical, and companies are moving toward a concept known as BYOD, or bring your own device. BYOD is the practice of allowing or even encouraging employees to use their own computers, smartphones, or other devices for work purposes. It is becoming a key enterprise influencer for moving project management applications from inside the firewall to third-party hosted cloud solutions. Mobile devices will socialize a project’s status to the entire team, displaying project schedules and tasks for wider understanding and discussion by teams. Using personal laptops, tablets, and smartphones to connect with corporate resources will facilitate access anytime anywhere for all project stakeholders. Embracing BYOD will affect the selection of project management software.

The project manager will need to lead the BYOD initiative and manage the technology, policy, security, and regulatory, and other factors that must converge in order to support the project team. Developing data ownership policies may require input from multiple stakeholders, including legal, information security, and management teams. Project managers will be responsible for access rights to all project information — therefore, a tool that has different access rights will be essential.

Enterprise mobility and BYOD influence over project management platforms should be embraced. Project managers can no longer hide in the project management office. Providing collaborative access anytime and anywhere is a trend well worth following.

Trend #3: Customizable Reports

Customizability will be at the center of enterprise project management software. The information that the chief information officer requires on technical progress differs greatly from the data required by finance. The information often resides in different programs, and the format of the reports that are generated vary greatly. As medtech project managers adapt to a changing healthcare landscape, stakeholders will expect customized reports that enable them to respond to changes quickly and easily. Project management systems will need to be able to harvest data from different sources and produce them in single, custom report and in a variety of formats.

This trend will lead medical OEMs to merge their customer relationship management (CRM) software and project management systems. Open application programming interface functionality will become an industry standard as opposed to a feature. Project management and CRM platform integration will bridge the gap between finance and operations by exchanging data between disparate systems, helping to provide transparency and build trust between the two teams.

Trend #4: The New Change Managers

In the new healthcare landscape, project managers will need to be more involved in change initiatives than in the past. Traditionally, the project manager’s task was to drive deliverables and focus on product development. By contrast, the change manager was dedicated to driving change management projects; assessing risk; tracking, managing, and monitoring change project details; reporting key performance indicators (KPIs); and facilitating team communication. In the future, executives will want more buy-in and support from project managers in respect to all change initiatives. The focus will need to shift from defining what the project is to deliver to why the project has been initiated.

Project managers will manage the mechanics of projects. They will be the early adopters, and their project reports will present detailed assessments of change initiatives. In the new era, project managers will be accountable for driving change not just within their teams, but across the entire organization. Project management tools will need to handle the change management story. These tools will have customized interfaces, and they will capture and track business goals, KPIs, change guidelines, and new workflows or processes.


John F. Kennedy said, “Change is the law of life. And those who look only to the past or present are certain to miss the future.” There will always be unknowns when delivering medical device projects, but an agile response helps manage projects successfully, particularly in a rapidly changing healthcare landscape. The key to staying ahead of your competitors is assessing the latest technological advances and developments and aligning your project management practices to respond quickly and intelligently.

Technological advances are dictating a new approach to project management. Four key trends will be at the heart of addressing the changing landscape: implementing an agile approach to product development, taking advantage of the cloud and employee’s personal devices, customizing reports, and modifying the role of project managers.

This article was written by Justin Kelleher, Ph.D., a project management office consultant with Cora Systems, Leitrim, Ireland. For more information, Click Here .