Creating new opportunities and exposing hidden risks in ... Creating new opportunities and exposing

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  • Case Study: Instrumental Design

    Creating new opportunities and

    exposing hidden risks in the healthcare

    ecosystem

    By Bryan Boyer & Justin W. Cook

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    Basic facts

    Key points

    If you only have time to read one page...

    The advocacy gap Can steel be too strong?

    'As regular as a chip shop' A Space of Possibility Redefining the user Looking Closely Narrowing in on a solution New Opportunities At New Scales A Pathway to Strategic Improvement

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    Credits & contacts

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    Client

    DePuy

    Core Design Team

    Helen Hamlyn Centre

    Stakeholders

    DePuy, RCA, surgi- cal staff, patients, hospitals, insurance providers, National Health Service

    Sector

    Health care

    Start date

    September 2006

    Status

    Ongoing

    Project cost

    1,000s 10,000s 100,000s 1,000,000s

    Helen Hamlyn Centre

    Rama Gheerawo, Deputy Director

    Maja Kecman, Designer

    Lisa Stroux, Designer

    Karina Torlei, Support, Future of Surgery Forum

    InnovationRCA

    John Bound, Co- Director

    DePuy

    John Naybour, Director, Strategic Marketing

    Consultants

    Martin Bontoft, User Research & Design Strategy

    Gareth Jones

    75,629

    Total knee replace- ments in the UK Source: National Joint Registry 2008

    £30,000

    Price of old surgical steel instrument kit Source: RCA Helen Hamlyn Centre

    £195

    Target price of new plastic instrument kit Source: RCA Helen Hamlyn Centre

    Basics Key individuals

    By the numbers

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    1. The Helen Hamlyn team started from the facts. Using a variety of observational techniques they discovered that the current tools used for knee replacement surgery left plenty of opportunities for improvement.

    2. The surgeons themselves were one of the groups who would have to be convinced about the possibility of new design solutions.

    3. Material exploration led to the possibility of using plastic instead of surgical steel. This improved usability and accuracy while reducing the possibility of sterilization errors but met with resistance because of perceptions.

    4. By focusing on the vast majority of typical surgeries the team were able to significantly simplify the instruments.

    5. Expanding from a focused brief to look

    at surgical instruments, the team also developed concepts for the storage and sterilization of instruments.

    Innovations carry risk, but so too does the status quo. Diligent ethnography identifies innovation opportunities.

    Expert users are sometimes blinded to the necessity of innovation by virtue of their highly developed coping skills.

    Mindset change is part and parcel to technical innovation.

    Use cases help identify high-value design opportunities.

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    Overview

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    As a giant in the field of orthopedic implants and related products DePuy, a subsidiary of Johnson & Johnson, had enjoyed a long period of success but was still anxious to enhance their ability to innovate and continue challenging the status quo. Using the specific problem of total knee replacements as a test case, DePuy asked the Helen Hamlyn Centre (HHC) at the Royal College of Art in London to help them rethink the tools used in surgery, and through this collaboration provide a model that would allow DePuy to more rapidly develop products better suited to the chal- lenges faced by surgeons and their patients.

    For good reason, innovation within health care must pass mus- ter of rigorous review boards, making it one of the most challeng- ing contexts to innovate within. The risk inherent to this approach is its implicit assumption that the status quo has been consciously chosen, when many of the conditions we take for granted have come to be out of coincidence or contingency rather than explicit design and decision-making.

    Innovation efforts are not evenly distributed. The heteroge- neous landscape of innovation within the health care sector has yielded a situation where some decisions are guided by very deep

    Modern health care systems are as vast and com- plex as they are essential to the existence of a healthy society. Eliminating risk in this context is not only a moral imperative but also a prudent business deci- sion and a precondition for establishing general trust in the system. Developments in medical treat- ment, devices, and procedures are subject to high levels of scrutiny so as to avoid reckless risk-taking at the expense of someone’s quality of life, or their life itself. Yet this calculus does not account for an important factor—the status quo. By slowing down the innovation cycle we also extend the life of exist- ing solutions which themselves carry risks.

    Case narrative

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    accumulations of knowledge and supported by intensive research and development, while other choices are made in an informa- tional context which has barely changed in decades or even centu- ries – whether this is the result of problems going unseen or a lack of clear funding support for the problem area.

    One challenge to innovation in health care is the extreme degree of skill and expertise of the physicians, nurses and hospital staff who form the core of the system. Paradoxically, these are the individuals who know the functional requirements of their tools and procedures best, yet typically have the least amount of time to apply that knowledge towards improving tools and techniques. In effect, a practitioner adept at improvisation can cause a negative net impact to the health care innovation ecosystem by prohibiting the specific inadequacies of the tools and practices they improvise around to bubble up to parties who are able to develop and dissem- inate systemic solutions. Improvisation allows the best surgeons to develop coping mechanisms that allow them to produce successful outcomes even when their instruments fail them, but why accept this additional risk if it can be mitigated?

    The Advocacy Gap

    The surgical theatre is one of the most demanding environ- ments on earth. High-stakes and time-sensitive, surgery is a stressful endeavor, the brunt of which is borne by the surgeons themselves who are ultimately responsible for the success or failure of an operation. We expect the medical equipment used in these situations to be highly tuned to their specific use. The question is, “from whose perspective?” When observing knee surgeries in mul- tiple contexts the HHC found that some of the best surgeons have adapted to their tools so fluidly that they’ve developed a blindness that prevents them from seeing the deficiencies of the instruments.

    Surgeons have extremely demanding needs but are also highly competent individuals able to adapt quickly to evolving situations by developing on the spot coping mechanisms. The intense focus

    “We are very conservative… If we try to use a new- fangled thing and it goes wrong… it ruins someone’s life. Progress has been evolutionary rather than step change.” Professor David Barrett, Consultant orthopedic surgeon, Southampton University Hospital

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    of the operating theatre doesn’t leave much room for meta-con- versations about the efficacy of tools. As soon as surgery is over the focus quickly moves to other patients and other operations. In effect, this means that the instruments have very brief windows of use during which time the primary users are intensely focused on not allowing failures of any kind, for any reason. These instru- ments, which should be the focus of significant attention, receive relatively little.

    Compared to the remaining lifetime that a patient will live with their artificial knee, the surgery is over in a flash. The patient experiences the new knee all day, every day. Embedded within the human body, the implants have natural advocates in the patients who receive them, who can and will complain about pain or dis- comfort and make sure that their voice is heard. With the implants naturally receiving so much more attention than the instruments, it’s no surprise that the implant innovation cycle is approximately one third that of the instruments used to install them1. Without a comfortable implant surgery would be pointless, but nevertheless the surgical procedure itself is a significant risk and any opportu- nity to reduce that risk is important.

    Can Steel Be Too Strong?

    The importance of instrumentation can be observed in the respect garnered by the term “surgical steel,” an honorific reserved for the highest grade of equipment. The power of surgical steel’s “brand” has spilled over to other industries such as appliances and automobiles where stainless steel enjoys a similar level of respect and commands an added premium. As a recognized indicator of sterility, durability, and strength, surgical steel has become a veri- table precondition for medical instruments.

    Yet it might be possible for something to be too durable. The long lifespan of stainless steel surgical instruments decreases their

    1—Naybour, John. Interview by authors. March 2009.

    “I am covered in blood and fat and it has no grippy handle... it flies out of my hand every now and then. It’s appallingly bad design.”

    Professor David Barrett, d