Doğan Şekercioğlu
Biotronik
Handheld Medical Device (iLP) | IDEO | 2019
Project Lead / Industrial Design
Generated the final industrial design
Planned and conducted design research
Synthesized research into a coherent design strategy
Contributed and art-directed final deliverables
Managed client activities and communication
Guided junior industrial designers
Additional Credits
Yeongkeun Jeong
Maximilian Löw
Elger Oberwelz
Biotronik asked IDEO to design a new handheld medical device to safely deploy their groundbreaking leadless pacemakers into patients' hearts and define the design strategy for a new handheld product category.
I led the design team, generated the final concept, planned and conducted design research in five cities, managed client activities, art-directed final deliverables, and synthesized the handheld portfolio strategy.
We prototyped five distinct concept directions to test haptic feedback, ergonomic needs, task transitions, and brand attributes. The resulting form factor was beautifully rational, and the portfolio strategy was scaleable without being prescriptive.
Design Research
Traditional pacemaker "cans" are placed just under the skin below the collar bone, and a "lead" extends into the heart for pacing. A "leadless" pacemaker is planted directly into the heart, leaving no visible scar or contour.
The iLP tool must drive a catheter into the heart through a blood vessel, deflect the catheter into the right chamber, and plant the leadless pacemaker into the heart wall.
Looking In
I planned a 3-day immersion workshop with our client in Portland to kick off the project. They brought us up to speed about this complex medical procedure, shared their thoughts and expectations, and helped us prepare for the field.
We synthesized the information real time and visualized the complete journey and its stakeholders. This was a first for our client team.
Field Work
We talked to 18 stakeholders who would potentially interact with this new product. I ran three rounds of research, and during each session, I increased the fidelity and specificity of the inquiry.
Round 1 - User Interviews
During our first round, we talked to both electrophysiologists and sales representatives in San Francisco and Los Angeles. We wanted to understand the brand perception and initial reactions to the emerging iLP implant procedure.
This first phase helped us understand the higher-level physician needs and context.
Electrophysiologists updated the implant journey on the spot, highlighting the potential stressors.
Round 2 - Broad Prototype Testing
In the second round, we tested functional prototypes and got hands-on feedback from end users. I designed the research plan to interview practitioners of different experience levels, from medical fellows to superstar electrophysiologists.
BIOTRONIK team joined us at IDEO to share their technical expertise, and guide us down selecting concept directions for prototyping.
At the end of this phase, we had two clear concept directions for further refinement.
Round 3 - Downselected and Refined Prototype Testing
We joined BIOTRONIK in Orlando and Portland to observe clinical testing for the last round of design research. These in-context sessions finalized our concept selection process. They solidified our insights and helped us to get more nuanced feedback on affordances, ergonomics, and physician expectations from this new technology.
Design Principles
I distilled our research into four principles rooted in our research synthesis and BIOTRONIK's mission. These principles will frame our design decisions during development and enable an aligned hand tool portfolio in the future.
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Balance familiarity with the distinct needs of a new procedure.
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Design for the complete journey, not for individual tasks.
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Draw the physician's focus to where it's needed most.
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Minimize moments of ambiguous mastery.
Prototyping
I encouraged my team to start building from day one with increasing fidelity throughout the project. We meticulously iterated each final design detail with sketches, videos, and physical prototypes.
Sketching and prototyping started from day one, and this rapid iteration led us to the finish line with confidence.
Low-fidelity experience prototypes combined with sound cues helped us to get rapid feedback on complex interactions.
We built more than a hundred prototypes to explore ergonomics, texture, proportions, weight distribution, haptic fidelity and secondary interactions.
I utilized of the shelf parts to quickly prototype haptic qualities (resistance & stepping) of the slider and the dial.
Final Design
The final design was a delicate balance of the physicians' procedural needs, the needs of other stakeholders involved in the procedure, BIOTRONIK's brand vision, and technical capabilities.
Breakdown of the primary implant tool components.
Product Haptics
Since the catheter is inside the body, physicians prefer to track the procedure on live fluoroscopy. To maximize their attention on fluoroscopy, I designed passive and active haptic feedback features to aid in developing muscle memory and highlight key moments.
Haptic Feedback - Active Features
Deflection Dial: The rotation of the dial is signaled by a slight stepping vibration, communicating the catheter deflection at the tip. The embossed zero point helps physicians keep track of the rotation without looking down.
Deployment Slider: The pacemaker is deployed by a slider in three distinct steps. When the pacemaker tines are out of the cup at the end of the catheter, it is communicated to the physician with a subtle mechanical vibration of the slider.
Active haptic feedback is utilized to communicate key moments during the implant procedure when sight is occupied.
Haptic Feedback - Passive Features
I utilized 3D texture, product contour, embossed details, and changes in surface texture to guide the physician's touch from when he takes hold of the tool until he finishes the deployment.
These qualities were primarily haptic affordances and, secondarily, aesthetic features.
Contour of the iLP handle guides the user's touch to perform tasks with confidence.
Product Graphics: Branding
The handle form dictated by the strict usability needs and logo placement does not always align with it. Since the logo is primarily a marketing attribute in medical context, it should be placed in a way which will enable the marketing team to create attractive communication materials.
BIOTRONIK is expected to deliver high quality German engineering and it should celebrate its origin in every market.
Product Graphics: Icons
The functional graphics on the handle are reduced to minimum based on necessity. By involving physicians and observing procedures, we identified what type of visual information is crucial while others may be redundant or out of sight.
When new icons are needed, it is important to remember representing the function they communicate in its purest form for clarity and recognition.
Packaging
The sterile packaging plays an important role in the implant journey. Pulp structural packaging and inner sterile packaging are designed with modularity across catheter tool portfolio in mind.
While pulp packaging ensures structural stability during shipment, storage and transfer, inner sterile package is autoclaved vacuum formed plastic.
The top film layer is designed to strike a balance between existing BIOTRONIK brand elements and new industrial design language.
Structural pulp packaging can be used for other similar catheter tools and it can also be recycled easily after use since there are no printed elements.
Design Principles
1
Balance familiarity with the distinct
needs of a new procedure.
Physicians develop their habits over years of practice. They develop muscle memory and mental models based on their most recent practice and the broad spectrum of procedures they mastered.
Biotronik needs to understand what already works and how best to apply it, but it must also be willing to develop new interactions specific to the procedure to maximize procedural efficiency.
2
Design for the complete journey,
not for individual tasks.
The implant workflow is complex - It involves multiple stakeholders, including scrub technicians. Designing only for the physician causes gaps in the overall user experience, particularly when an extended team of stakeholders participates during the procedure.
It is imperative to remember the entire journey and highlight the moments of handovers, collaborations, and troubleshooting during an operation. These moments are understandably the most stressful and elevate risk when overlooked.
3
Draw the physician’s focus to where
it's needed most.
The implant and explant procedures are tracked and evaluated through fluoroscopy (live x-ray), becoming the physician's only metric for success. Anything that competes for their attention and forces them to avert their gaze is seen as both a nuisance and a potential risk.
Biotronik tools must be designed with appropriate visual, haptic, and auditory feedback to ensure the physician’s attention is enhanced with critical feedback - regardless of the tool’s position in space.
4
Minimize moments of ambiguous mastery.
Humans have evolved to make sense and draw patterns from sensory feedback to help navigate their lives. Physicians are no exception and develop their senses when there is no clear feedback to rely on. However, this sensory feedback can be subjective and hard to translate consistently.
Biotronik’s solutions should strive to minimize or eliminate moments of ambiguity during the critical moments of the user journey. Feeling the heartbeat during the tug test can be a great way to test tine engagement for experienced practitioners, yet it takes a novice numerous attempts to master this.
A spring loaded gauge calibrated for required tissue attachment force minimizes subjective evaluation based on limited x-ray visibility and feel.
The device's contour enables the physician to retract the device while pushing the pacemaker out in mid-air predictably.
Design Language
The final design was a careful distillation of the physicians' usability needs, needs of the stakeholders involved in the procedure, BIOTRONIK's brand vision and available manufacturing capabilities.
A quick exploration of the Biotronik Style Guide on different devices of their portfolio.
Biotronik Style Guide can be applied to physical touchpoints beyond their devices with the support of their budding internal design function.