Scope creep happens. We can’t stop it, we can only hope to contain it. Let’s talk about that.
Last week I presented the Universal Job Loop (UJL) as a simple framework to represent the building blocks of a complex job. Each UJL includes divergence, synthesis, convergence, and iteration. To explore the topic of scope creep, I will use this framework and an example case of hospital based medical device innovation by a caregiver (such as a nurse).
Throughout the post I’ll be referring to upstream and downstream. For calibration: upstream will be defined as early in the innovation process. All the way upstream is when the nurse first experiences a frustration in the clinic and has a lightbulb flicker to solve it. All the way downstream may be 5 years later when a contract manufacturer is assembling, packaging, sterilizing, and shipping the finished product to the hospital for nurses to use.
In the current environment, we’d love to see this 5-year upstream to downstream journey reduced to 5-months. Faster is better. This post is not about the time, the investment, nor the likelihood of success in completing the journey. This post is specifically about scope creep. Is the frustration that happened upstream resolved by the product that was delivered downstream? Is it even remotely recognizable?
The shape of the UJL framework unintentionally resembles a top view of a canoe. I’m going to capitalize on this coincidence by imagining the UJL floating from upstream to downstream. Each UJL represents a different canoe (not necessarily how far upstream or downstream it is).
The boat with the longest journey is Clinical Immersion. This one may start at the highest point upstream and in best practice continues all the way downstream alongside Manufacturing. The other two boats are Design and Development. At some point along the journey, all 4 UJL vessels may be seen floating side by side, or any one leading another.
This is a dramatic simplification of the significant hurdles along this journey. This imagery is intended to describe a nonlinear process. It’s not a perfect framework. The image itself appears linear in nature. Separate vessels may imply different crew members, when in reality, the same crew might be navigating all of them. An important reminder to the UJL framework is they do not imply job order, just that jobs are getting done.
During Clinical Immersion, the nurse has recruited some engineering students from a local university to observe and interview other nurses and stakeholders involved in the given treatment. This divergent phase exposes the students to dozens of unmet needs that they record. They keep their work in notebooks, emails, and shared Google documents. They collaborate using Post-it notes and whiteboards captured in photographs. In the synthesis phase, the students reframe their notes into defined unmet needs. A good place to do need statement development is in a Google document or virtual whiteboard where the team can cultivate the wording and share for feedback. The convergent phase of clinical immersion is to prioritize the needs. A good tool for need screening is an Excel spreadsheet or Google sheet to assist in ranking the list. This iterative process involves additional observations and interviews to validate the needs. New needs are observed, defined, and prioritized in each round of the process.
The Design job includes brainstorming ideas to address the needs, integrating those ideas into concepts, building prototypes, and then testing those concepts with the stakeholders. Each round of the design process may include different resolutions of and reasons for prototyping. They may be low resolution sketches to high definition 3D prints. They may be intended to learn something about ergonomics, technical feasibility, or assess market value.
We can already see that the Clinical Immersion job and Design job may be best happening together on the water.
In practice, students may have started with Clinical Immersion and then sometime later put the Design boat into the water. They may even have begun some Development along the way. Ultimately though, if the journey is to be successful, there’s likely to be a personnel change.
The students graduate and the nurse pitches the idea for a grant to an innovation group at the hospital. The nurse and the students have validated unmet needs, built prototypes, and developed a proof of concept that lead to a winning grant application. It’s not a lot of money, but it’s enough to engage a professional design group to take over the boats on the water.
The focus is on Design. Both the budget and capability of the firm will be the nuance of how much Clinical Immersion continues to float downstream and how much Development advances. All too often the Clinical Immersion boat is left behind. As the journey progresses, more progress brings more funding, and yet another ownership change from industrial design to product development. By the time we are downstream, is Manufacturing the only boat left in water?
Let’s take a closer look at how scope creep happens along this journey down the river.
The innovation process includes strategy and decision making along the length of the river. Sources of truth and details are lost along the way. We may know that it needs to be portable and have specifications including weigh less than 5 pounds, fit on a rolling cart, and last for 12 hours. But in the thick of development, it turns out these specifications are at odds with each other. Something’s got to give. Should we sacrifice 2 hours of battery life to maintain the size and weight? The original source of the specification is lost. If it was that it must last an entire 12-hour nursing shift, it may be better to compromise on the weight rather than on the time.
Searching for that original source of truth may find its way to a bureaucratic road block. The decision from leadership may be tied to technology that someone stuck their neck out for. Rather than chase down such a road block, an engineering team may take the initiative and do the tackling that needs to get done, potentially making an ill fated choice to sacrifice on time rather than product weight.
Through the divergent, synthesis, and convergent phases of the UJL, different methods and tools are used. Often the transcription of information is left to one person, such as rewriting information captured on Post-it notes in a group session to an Excel spreadsheet for later prioritization. Whether intentional or not, leaving transcription of group work to one person introduces bias that can contribute to scope creep.
It’s a long journey and ownership will often change along the way. At the start of the journey, the idea may be owned by a single person, that original nurse. In this example case, ownership transfers from the nurse to a student group, then back to the nurse, then to an industrial design firm, then to a product development firm, and finally to a contract manufacturing firm.
Each ownership transfer will often coincide with a rewriting of history. This happens to ensure everyone is on the same page. Where did we come from and where are we going? For medical device design, at least one of undertakings is to assemble a formal design history file as part of the medical device quality system regulations. Each time history is rewritten, the interpretation of the past impacts the future.
Imagine a scenario where one single organization manages the entire project from upstream lightbulb to downstream shipment of product. Personnel turnover is likely inevitable and only serves to exacerbate the previous contributing factors to scope creep.
Ideally we want to see that Clinical Immersion UJL taking the entire journey. Sure, the people in the boat may change along the way. However, the consistency of staying connected to the users and alongside the other boats for the full length of the trip will minimize scope creep. It is vital to maintain a line of sight to those original sources of truth we worked so hard to dig up in the first place.
Coordination is key. The worst case scenario is these 4 boats with entirely separate crews and checkpoints along the way, such that only one ship at a time is ever on the water. The Clinical Immersion team takes the boat to a checkpoint and hands off to the Design boat. Design hands off to Development and on down the river to Manufacturing who navigates solo to the destination.
Coordinating the boats on the water enables Design to ask Clinical Immersion to float ahead and gain some intelligence. They may even do a float along with Manufacturing to see how that may impact Design.
Communication of unbiased information is critical to minimize scope creep. Upstream the information can be scattered in notebooks and on whiteboards. Downstream the information is meticulously maintained in Bills of Materials and Detailed Manufacturing Specifications. How did it get there? Compromising the creative upstream process and/or relaxing the downstream pragmatism is not the answer I recommend. Rather, use Genius of the And mentality to maximize both creativity and pragmatism.
Scope Creep. If we can’t stop it, our only hope is to contain it. To do that, the best ammunition we have is consistency, coordination, and unbiased communication.
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