By Dr. Justin Kelleher, PMO Consultant for Cora Systems
This is an era of profound change with technology driving the agenda in previously unthinkable ways for the medical device industry.
The boundaries between different forms of life science and healthcare solutions are becoming more blurred – the landscape is changing in ways unimaginable only a decade ago. Information technology, nanotechnology, cloud connectivity, smartphone access and personalized medicine all seem to be rapidly integrating into one new healthcare landscape.
But, something is missing. Providers are not addressing some familiar topics. The way in which technology is delivered can be as important as what the technology is. Visionary products from wearable health monitoring devices for an aging population and miniaturization of implantable devices are coming into the market. But how will this happen in the near future?
We will take a look at how technology can be put into place more readily with some of the most outstanding project management trends that you need to prepare for in the medtech industry.
1. Continual growth of agile project management practices
About 15 years ago, the software industry was confronted with similar problems to those the medical technology sector is facing today. Nowadays, university students across all disciplines 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 are now delineated into user stories and burn down charts, or “show and tells” are used to report progress.
There is a lot of deliberate misinterpretation by executives of the agile manifesto – that team members stop producing documentation, scrum is an excuse to do whatever you want, it is too loose to pass tougher regulatory controls and the quality of the delivery will be jeopardized.
In a recent interview entitled “Agile Insights,” Frank Balogh of AOL was asked about agile practices.
“In a sense,” Balogh said, “Agile is like jazz. It’s like improv in a way. It’s not sheet music. We tend to now work in a world which asks us to deliver products quicker than maybe traditional models allow us.”
But what does that mean for medical device development? Given the proven success of agile development, an inevitable question for companies in medical and other regulated industries is can we adopt agile approaches in our environment? While medical device regulations do not prescribe a fixed lifecycle model, activities are still presented in a sequential manner, which naturally drives organizations back into waterfall development. However, several medical device manufacturers have adopted agile practices while keeping development in compliance with regulations, but conflicts still arise and decisions have to be taken in favor of agility or formality.
Scrum team members have to master technology and know their regulatory guidelines, e.g., FDA/IEC regulations, security or technical aspects. Of course, there are agile guidelines or standards available. In 2012, the Association for the Advancement of Medical Implementation (AAMI) released the TIR45 that guides medical device development companies on how to use agile under stringent quality regulatory processes. TIR45 is a prime place for novices or hardened agile veterans to gain insight into using an agile framework in the medical device industry. It’s a good reference point and demonstrates clear alignment with the IEC 62304 standard.
It became very clear over the past few years that scrum is not only an agile software development method. Rather it should be seen as a framework that reduces the complexity of product development into short cycles, called sprints. In scrum, you document only what has to be documented, the difference with other methodologies is the efficiency of the documentation. Daily scrum meetings should be viewed as a communication or a collaboration tool where transparency on what activities each team member carried out yesterday and what the team plan should achieve today are discussed and agreed. In many ways, it is 21st-century Athenian democracy – communities of people with differing skill sets working together to build the right solution in a timely fashion. Be careful, however, as Anarchism is democracy taken seriously!
In scrum, clients and users are a part of the product development process from project inception, for example, by taking part in the “show and tell” reviews at the end of each sprint. One accusation that is often being made is that with agile methods there is no planning. This is simply incorrect. In reality, there is constant real-time planning. Each user story is agreed during sprint planning sessions with new insights on requirements taken into immediate consideration. Team members and regulatory activities are mapped into the agile cycle in a time-boxed sequence.
Undoubtedly, we’ll continue to see the growth of agile practices in non-software based projects. Don’t be scared of it – agile is merely a logical way for teams to self-organize and deliver product functionality in pre-agreed, bite-size chunks. It’s that simple or that complex – the challenge lies in the organization’s readiness to accept this simplicity. The principles are straightforward but as we all know, the cultural and behavioral changes are not. One of the most difficult aspects of applying agile is about gaining trust between executives, the PMO (project management office) and project team members. As the saying goes: trust takes years to build, seconds to break and forever to repair. To refer back to Frank Balogh’s visual description of agile being similar to improv jazz – in agile, senior managers get to choose the instruments for the jazz session. They even get to choose the musicians that will play, but once the session begins they need to sit back and enjoy the music. Let’s just hope they like jazz!
To conclude, agile is a way of working that relies heavily on having a good tool for managing workflow. Find a suitable tool and be prepared to invest in customizing it.
2. Remote teams are the new normal
Geographically dispersed teams can offer huge benefits which include efficiency, cost savings and the ability to choose team members with the best skills, regardless of their location.
Recently, while working on a resource plan with a large, US-based life science company, a strange if not somewhat embarrassing situation quickly arose. We discovered an experienced pool of remote resources readily available to work; that the centralized PMO didn’t even know existed. How did we find this resource pool in only a few hours? We simply contacted geographically external line managers and related HR personnel to get their list of available resources. Let’s not be too critical here – it happens to even the most experienced project managers. It should be noted we were using a project management tool that integrated with the corporate HR system so resource allocation could be carried out in real-time within the tool. (Please refer to Section “Project managers are the new change managers”.) Once the resource pool was on-boarded onto the project management tool, they carried out simple skills-based resource allocation.
The next step was to unite this cross-functional team around the process. We agreed that stringent daily meetings (for example, daily scrum meetings) to communicate on user stories and progress clearly and frequently. Building trust and avoiding remote team members feeling isolated was achieved by frequent, fair and appropriate feedback. Recognizing and acknowledging successes was also achieved through the tool. So, looking ahead to the near future, it’s important to invest in a suitable tool for coordinating remote teams.
3. Bringing investors on the project journey
It’s 100 years since Henry Laurence Gantt, the prolific and brilliant Hoover Dam engineer, first introduced the most widely recognizable project management symbol – the Gantt chart. A century later and corporations are still looking for ways to stay ahead in the technology-rich environment – consistently turning to project management to deliver projects faster, cheaper and better than the year before.
In the past decade of economic chaos and instability, the financing of startup medtechs has never been tougher. Investors still don’t see clear paths to invest and oftentimes the exit points for investment are unclear. What does success look like? When is the next investment cycle? What are the early warning signs of failure? What is the minimum set of requirements for a product release? These are still profoundly important questions to agree up front with any investment board.
Having solid project, program and portfolio management practices in place still encourages initial investment and the continued ability to report progress through delivering measurable work packages remain the solid ground for continued reinvestment. Advice for 2017? Don’t forget the basics, agree to the portfolio roadmap upfront, identify programs of work, determine the critical path, describe the development process, include budget-monitoring controls and expenditure profiling in every investment board review and continue to report on all major risks and issues.
One of the observable trends over the past number of years is the increase in the number of chartered accountants that are now CIOs or portfolio managers. Projects are more about the bottom line than ever before. Therefore, think about your project as if it were your money. Would you continue to invest without any visibility on progress? Well then provide the investors with dashboards to build the trust to continue the investing culture.
4. Take project management to the cloud, and then BYOD
Mobile collaboration continues to be critical when choosing project management software. It is becoming a key enterprise influencer for moving project management applications from inside the firewall to third-party hosted cloud solutions. Mobile devices are socializing project status to the entire team, displaying project schedules and tasks for wider understanding and discussion by project teams. Access anytime/anywhere for all project stakeholders using personal laptops, tablets and smartphones connecting with corporate resources is becoming an essential factor in choosing project management software.
In our opinion, it is the role of the project manager to lead the BYOD initiative and to manage the technology, policy, security and other regulatory factors that need to come together in order to support the project team.
Developing data ownership policies may require input from multiple departments, including legal document owners, information security and management teams. Project managers are now responsible for access rights to all project information – therefore a tool that has different access rights can be a deciding factor. Agile practices and more self-directed teams have led to the need for more visual representations of project management information for all team members. Having regulation or guidelines embedded in the project management software keeps team members focused and aware of the standards they must follow.
Enterprise mobility and BYOD influence over project management platforms should be embraced by delivery organizations. No longer can project managers hide in the PMO. No longer can project team members not have an understanding of project scheduling. Providing collaborative access anytime and anywhere is a trend well worth taking into consideration.
5. Customizable project management reports and open APIs (to integrate with CRM and finance systems)
Customizability will be at the center of enterprise project management software now and into the future. The level of granularity and detail in project reports varies greatly depending on whom you are reporting to. Traditionally, project management reporting was carried out following strict “Chinese whisper” protocols. You reported to your boss who reported to their boss and so on up. No down-wind news was good news. Thankfully this type of siloed reporting is almost gone.
Nonetheless, the information the CIO requires on technical progress juxtaposed against the project budgetary data requested by the dreaded CFO function are just different – the data lives in different tools, the layout and format of the requested reports are so varied. We all know the junior project managers that immediately after their weekly project status meeting start preparing next week’s project report. How much time do you spend getting reports together? Obviously, different parts of the organization need different aspects of the project status information. Some managers want the report in slide format; others can only work with spreadsheets. Of course, there is a solution – invest in a project management system that harvests data from different data sources into customizable reports. (Once again, don’t forget the investors, as mentioned earlier in this paper, they want to see the project progress and expenditure profiling – “he who pays the piper calls the tune”.)
As enterprise businesses want to securely integrate their CRM (customer relationship management) software to their PM (project management) systems and vice-versa, the ability to have open API (application programming interface) functionality will become an industry standard as opposed to a “feature.” Project management and CRM platform integration can bridge the gap, for example, between finance and operations by exchanging data between disparate systems. Even if technical teams and finance are archenemies, an open API can provide transparency and hence build trust between the two teams.
6. Project managers are the new change managers
Heraclitus, the Greek philosopher, is quoted as saying, “change is the only constant in life.” One vastly under-rated theme is that for every technology introduction, change is the absolute constant. And technology companies, intentionally or not, sometimes forget to mention this. To continue a trajectory of steady growth, the global medical device industry must adapt to the dynamic changes disrupting the healthcare landscape. Mergers and acquisitions and new non-vertical partnerships are commonplace. Therefore, a question well worth asking is how can project managers get more involved in change initiatives?
Traditionally, the project manager’s task was to drive deliverables and keep focused on product delivery. The change manager was dedicated to making change happen in the organization. Other responsibilities include driving change management projects, risk assessment, tracking, managing and monitoring all change project details, KPIs and team communication. There is an obvious overlap between the two roles and down the tracks. I predict that executives will want more buy-in and support from project managers in respect to all change initiatives. If not, their competitors are!
It makes good sense. Project managers work closely with all team members, they work across disciplines, bridge communication gaps and drive education initiatives. In many respects, they’re the closest to the heartbeat of the organization. Consequently, their focus needs to shift from “what” the project is to deliver to “why” the project has been initiated. They also must change the enterprise’s culture and employee attitudes, which are far easier, said, than done, especially when change is passively resisted or actively rejected.
So, what does this all mean? Project managers should manage the mechanics of change management projects. They must become part of the change story, become the early adopters, their inputs should be requested and their project reports should always include a section on how the change initiative is going. Make it part of yearly objectives, recognize their successes and make them accountable to drive the change not just within their teams, but also across the entire organization.
And, of course, find a project management tool that can handle the change management story – one that has the ability to customize interfaces, capture and track business goals, KPIs, change guidelines and new workflow or process. Source a tool that will foster rich and relevant collaboration in a single workspace.
John F. Kennedy once said, “Change is the law of life. And those who look only to the past or present are certain to miss the future.”
To stay ahead, you need to look ahead. The secret to keeping ahead of your competitors can be found by reacting to some of last year’s project failures and building on your successes. Ask the difficult questions about your project management practices: What did we do really well? What can we do better? What are our competitors doing?
No matter how much technological advances are made, there will always be unknowns when delivering medical device projects. Change is a constant. Agile merely helps manage projects in light of these expected changes and will continue to grow as the biggest underlying approach in the short- to mid-term. Go slowly, be courageous and let it gain momentum.
Start considering how you will adapt your organization for greater agility, mobility, in the cloud project management, BYOD and managing remote teams. Don’t forget your investors. They’re like a family member – you won’t truly miss them until they’re gone. And find a suitable project management tool that meets all your needs. If you really want it to work, you will find a way. If you don’t, you will blame the tool.