Steve Jobs once wrote: “Design is not just what it looks like and what it feels like. Design is how it works.”
That axiom applies to medical devices, too — although I would suggest flipping the sentiment around. Design is not just what it looks like or how it works — but how it feels.
A design that looks like it belongs in a state-of-the-art operating room creates confidence, and that’s important. A device that works well is vital — it has to be precise and effective while standing up to the rigors of the operating room.
But for surgeons, the “feel” of an instrument is critical, too. In fact, good surgical ergonomics are critical to helping surgeons complete more procedures in a day, ease the backlog in our hospitals, and extend the career longevity of surgeons themselves.
As it stands, occupational injury due to poor ergonomics costs hospitals more than $190 billion annually in liability and lost income, and treatment for these injuries costs more than $100 billion annually. Studies have shown that 30% of surgeons suffering from ergonomic injuries at work felt that it impacted their performance. In the bigger picture, we are already aware of the global shortage of healthcare workers. An injury that sidelines a medical professional is riskier than ever for the health of the system.
MOLLI® — a precise, easy-to-use new technology for breast cancer localization — is a good example of how thoughtful design and physician ergonomics in medical technology support a better physician and patient experience and greater efficiency.
How it Works
A good design starts, of course, by addressing an existing problem. MOLLI began because, when marking a breast cancer lesion for removal (which is known as breast cancer localization), there’s a long-standing challenge that needs to be addressed.
Many hospitals still use wire-guided localization, a method of localizing lesions by inserting wires into the breast to mark the location of the abnormal tissue. The technique hasn’t changed much in 50 years and requires coordination among the patient, radiologist, surgeon, and pathologist. The technique requires the lesion to be identified on the same day as the surgery, which can result in a long day spent waiting at the hospital between the two procedures. This is far from ideal.
Adopting wire-free surgical technology, on the other hand, means patients are not required to spend their preoperative time — which can easily and unpredictably be extended — with the discomfort of the wire placed in their breast. The wire has also been known to become displaced or transected during surgery, which can lead to inaccuracy and additional procedures, or migration.
MOLLI works differently. It implants a tiny tissue marker — about the size of a sesame seed — to mark where the tumor is in the breast for the surgeon. The MOLLI system uses a wand that detects a marker and visualizes its location on a tablet, helping surgeons locate lesions more efficiently with improved accuracy. The localization procedure takes only five minutes. This gives patients autonomy over their scheduling and creates flexibility for health systems to adapt quickly to changing needs.
Localization without wires helps to ease backlogs by decoupling implantation from surgery in a much more patient-centered, efficient approach. This allows for flexibility when it comes to scheduling surgeries, reduces the impact of unforeseen delays in radiology, and increases the number of procedures that can be performed in a day. Simply by decoupling localization from surgery, care teams can optimize their workflows to make care for patients more efficient and timelier. Hospitals can see a 34% increase in the scheduling capacity of radiology departments and a 41% increase in breast-conserving surgery programs — which is important to reduce surgical backlogs.
Radiation-free
Again, thinking about what Steve Jobs said, for a new device to be accepted and adopted, it has to work better — and preferably be easier to adopt — than the other alternatives that are available.
One of the other replacement technologies vying to replace wire-guided localization is radioactive seed technology. However, that technology is not without its challenges.
With a radioactive marker, the time between placement and surgery is seven days. However, with MOLLI, that window is as wide as 30 days. In addition, the implementation cost for radioactive seed localization can be up to nine times higher. Radioactive seed localization can run up to $250 per placement, and annual operating costs have been shown to be over $80,000. Upfront, these costs can be a significant barrier to overcome, especially for smaller cancer centers, and non-radioactive localization technologies eliminate any anxiety patients may have related to radiation exposure from radioactive seed localization methods.
With no wires, and without radioactive technology, hospitals can avoid expensive equipment and extensive safety regulations around radiation and disposal protocols, making MOLLI accessible to smaller regional health centers as well as large urban ones. Being radiation-free also helps reduce anxiety for hospital staff: their anxiety over additional radiation exposure, and anxiety over tracking and accounting for every tiny radioactive seed that routinely gets lost in the operating room.
How it Feels
Finally, how a device feels is no trivial matter. In fact, it’s not just a matter of ergonomics but, ultimately, of equality and inclusion.
In the last 50 years, we’ve learned a lot about surgical ergonomics. Traditionally, medical instruments are created for men’s hands. That means for women — whose hands are typically smaller — surgical devices can become uncomfortable when used over long periods of time. The ergonomics of the MOLLI device were carefully considered to ensure it fits all surgeons’ hands. As well, the tablet can be mounted on an IV pole so surgeons can see a readout at eye level instead of straining to look down at a console on a cart.
This is important: a recent study, “Working Through the Pain: Surgical Culture and Musculoskeletal Injury,” shows that female surgeons are less likely to report their injuries or even show discomfort, lest they be judged as “weak” compared to their male colleagues. In addition, it was found that when female surgeons were assertive regarding having their needs met, they were sometimes labeled as aggressive or having low worth. Understandably, it’s difficult to continue in one’s profession under these conditions. In fact, by 2025, a shortage of approximately 33,0000 surgeons has been predicted in the United States — musculoskeletal injury is only one factor leading to this projected shortage, but it is one that can be prevented.
Medical Design Briefs reports that “best design practice targets the 5th percentile female hand to the 95th percentile male hand to accommodate the physical range of grasp, motion, and flexion. Handheld and hand-intensive design for precision instruments must accommodate a range of 1.75 inches in hand length and 1 inch in hand width.” Every human is unique, and diversity in shape and size is the main challenge when designing handheld products.
The MOLLI Wand® is “so easy, a 3-year-old child can do it,” reports Medical Device + Diagnostic Industry (MD+DI). Surgeons report the learning curve is swift and the tool is elegant in its simplicity and comfort. MOLLI gives surgeons more flexibility to make incisions where they want to reduce visible scars. The MOLLI Wand’s smaller size, tapered tip, and 10-degree curve for tight surgical cavities make it ideally suited, even for oncoplastic procedures that require a higher level of precision.
Ultimately, though, the risk of occupational injury from poor design is not just only an equity issue, it is an issue of the overall viability of the health care sector. Keeping surgeons safe so they can continue to perform is key to keeping costs down and services running.
In other words, “feel” is everything in surgical design.
An Elegant Solution
As a scientist, a woman, and a company leader, I am proud that MOLLI Surgical has created a design that works — not only in a technical sense, but in terms of what it does beyond its immediate use in the operating room.
It’s accurate, effective, increases accessibility, and promotes equity. It also introduces more flexibility in scheduling and offers an ergonomic design so that more patients and more surgeons can embark on their cancer treatment journeys with less anxiety and more ease. I believe it’s well-placed to support hospitals and administrators through difficult backlogs and shortages we are facing now and down the road.
And I have to think that Steve Jobs would approve.