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Perhaps you’ve found yourself in this situation. Your product development team is well on its way into a project, and everything is going according to plan. Then, the competition comes out with a new product. Management says that the current project scope will no longer cut it; you’ll have to incorporate additional product features—the company doesn’t have a choice. Suddenly, your team is under immense pressure and, regardless of your best efforts, you miss your deadline.
Maybe this scenario also sounds familiar. Your team is instructed to develop a product for specific countries and for a specific segment. After some time, you’re told that the product will now also be sold in additional locations and will cover other segments, all with different testing and registration requirements. Going through a product redesign as well as a second testing and approval process for the additional regions/segments could potentially take more time and resources, stressing your team and ultimately delaying product release.
“Scope creep happens all the time,” said Shaher Ahmad, Founder of 4S Med-Device Consulting. Ahmad is an independent consultant with more than 25 years of medical device R&D and product development experience at OsteoMed, Stryker, Zimmer and others. “It’s a challenge that is common and one that the majority struggle with.”
Ahmad said that product development teams often stumble when edicts to change project direction and deliverables are dictated without more people or time to get it done. Sometimes, even if more resources are provided, it doesn’t help make up the time it takes a third party to test a product; those are usually set and hard to change.
At the same time, change is often seen as a natural part of product development. It is to be expected, and teams must adjust and deliver.
“It’s extremely frustrating for people and you end up with a team that’s not engaged, and the results will suffer,” Ahmad said. “When communication becomes edicts of ‘just get it done,’ you lose people—if not physically, then mentally.”
Ahmad recommends that companies and teams take a systematic approach to adapting to inevitable changes without having to improvise on the spot. He said that, while this process may seem like common sense, it’s not used consistently everywhere. It’s critical to establish an understanding among teams in regard to how to prepare for scope creep so that everyone is on board with the change to minimize the impact.
Establish and document requirements
Before anything else, establish, document and approve requirements. All stakeholders, from leadership to middle management to marketing to the design team, should have a chance to review the requirements so that everyone is on the same page. It’s important that stakeholders not only approve the requirements, but also truly understand what they mean and make sure they are achievable.
“The project requirements need to be well understood, agreed upon and easily accessible to everyone,” Ahmad said. “This is truly the foundation of what you do.”
Set up a change control process
It’s important to address changes in a systematic fashion to avoid projects going too far off track. Ahmad recommends that all project stakeholders discuss and consider changes to see if everyone is on board and truly understands the ramifications of the change.
“Make sure the scope is extremely clear and well understood by the stakeholders,” he said. “For example, is it essential to make that device housing black-anodized aluminum after you’ve been working for the past six months on getting that nice matte-finish stainless steel and already set up the manufacturing process to do so? Does everyone realize what it’s going to take in terms of time and resources to change it? Everyone should understand the full ramifications of the change and decide if it’s truly necessary.”
Create a clear project schedule
After communicating, reviewing and approving requirements, create a schedule that is in line with the expected deliverables—no more and no less.
“This sounds like a no-brainer, but having a clear, well-thought-out schedule that all stakeholders endorse is extremely important,” Ahmad said. “If everyone agreed on the requirements, challenged the proposed schedule and signed up to the level of resources allocated to the project, then they should appreciate the ramifications of coming back with a significant change.”
Plan for contingencies, but don’t go overboard
Having zero contingency allowance is unrealistic, Ahmad said. It’s necessary to plan based on real and well-thought-out project risks.
A project manager may have 10 milestones to deliver and decide to allow a two-week contingency for each. That’s 20 weeks of added project time that can easily be consumed if not managed well. “That’s going overboard, in my opinion,” he said.
Instead, he suggests adding contingency at the end, again based on risks and examples from prior projects. For instance, if your project schedule comes to 24 months and you have a technology risk that will require three to six months to address, then it is appropriate to negotiate that possible added time as a contingency allowance.
“The project manager may say, ‘Here is what we are doing to manage risk and meet or exceed the 24-month schedule. But if the following risks do materialize, then you are looking at another six months, worst case. Anything beyond that you can hold me accountable for,’ ” Ahmad said.
Make and keep commitments as a team
The project team must not only be part of developing and agreeing to all requirements; they must also embrace the change control process. It’s counterproductive for one member to sign off on changes without consulting the rest of the team.
Ahmad has seen this happen when a project manager or a department head promises management something during a boardroom review, or someone from the R&D team has lunch with the marketing team member and agrees to include a new product feature they’ve been experimenting with that isn’t really ready yet.
“Making commitments without the team is dangerous,” he said. “Usually people come back with egg on their faces and trust is broken.”
Following these steps will help minimize the impact of scope creep and ensure that projects are well managed with all stakeholders aligned.
“Change is going to happen,” Ahmad said. “Markets, customer needs and preferences, competitive environment and regulations change. How you handle these changes is really up to the project team and the leadership. It basically boils down to open communication and being honest.”
Kathie Zipp is an ORTHOWORLD Contributor. Shaher Ahmad is Founder of 4S Med-Device Consulting.
