Voices

Kelly's Voice

After dabbling in research and industry through internships and graduating from UW-Madison with bachelor’s degrees in biomedical engineering, chemistry and biochemistry, I was hired into an engineering rotational program ready to tackle the needs of modern health care. In my first three years following graduation I was fortunate to be exposed to more industry and healthcare experience than I ever thought possible. I had access to operating rooms, was on manufacturing floors, in innovation and business strategy sessions, and watched in awe as a product that I designed was placed on a baby of only 26 weeks of gestation. I went on to coordinate the innovation efforts of a start-up company that developed blood transfusion safety products and launched a variety of redesigned transfusion safety wristbands into the market. Following various other experiences, I began my own company, which has enabled me to tackle a variety of projects for various industry clients. These projects have focused on clinical knowledge discovery, risk assessment, device benchmarking, claim substantiation, and innovation/ideation.


I have covered a lot of ground in my thirteen years in the medical device industry, but have not had the impact on clinicians and patients that I had always hoped for. While many, many solutions were extensively researched and crafted in the conference room, very few have been implemented on the front lines. All the hours spent defining the state of the art, observing clinical environments, connecting with experts in the academic and clinical space, and lessons learned during patient trials reside in neatly organized, quality controlled, three ring binders – as required by medical device quality systems. Most of this insight will neither be published for the benefit of the clinical community nor become incorporated into new products. Desire to maintain competitive advantage but lack of a strong business case and/or funding keep this information from benefiting healthcare workers and patients. 


Time has so many meanings and interpretations, especially as it relates to human health. There are decade long drug development efforts embarked upon by pharmaceutical companies, two-year return on investment required by the medical device business leaders, days spent waiting for a diagnosis, and split second decisions that can mean life or death for a clinician or patient. In the execution of Health Care, each of these timelines has a role to play and as many industry leaders have said to me, “that’s just business”, but I can’t help but lay awake at night and think about this disconnect. It was not the type of drape, or mask, or blood collection equipment that saved my life during the birth of my son; it was the quick thinking and dedication of the clinical team that did. On the other hand, I know that they could not have executed on those tasks without the drugs, technologies, and devices that were at hand. So, is it patience or impatience, split second decision making or persistence, or is it just all about timing? Whether nurse or engineer, caregiver or patient, each path holds its own lament, frustration and wear; but indeed, timing is everything. 


I believe the time is now to form a formal partnership between clinicians and engineers, one that brings meaningful change to medical technologies, devices and processes from the front lines to the board room. Regardless of the methods and milestones, the goal to improve Health Care is mutual and each participant dependent on the others for success. For those that strive for solutions, to mend the broken, to deliver care, it is inherently difficult to place their own needs in the forefront. However, the patient care experience depends upon the quality and efficiency of these pillars, of nurses and engineers; and perhaps even more so on their partnership. The nurse must have reliable tools and processes that enable delivery of care in the moment. The engineer must have reliable information and requirements to supply the tools and processes that meet the need in time. So, the question is not if or when, but how nurses and engineers can unite to improve job and patient satisfaction.


There is no lack of initiatives or approaches to tackling the task of systems change in health care. While there are many clinicians that currently identify needs, propose solutions, and aim for improvement, the majority have difficult and demanding day jobs that do not leave time for or incent them to transform Health Care. For those who do succeed in proposing new solutions, the path to commercialization and/or implementation is one of high cost, long timelines, and requires specialized knowledge to navigate. So, how do we achieve the needed change in a timeframe that will make a difference? Modernization of health care will not take place in a class or conference room, in a clinical publication or within a FDA guidance document. It will be achieved through the daily activities of caregivers and their patients. But it will not be enacted or maintained unless all parties vested in the delivery of Health Care work in concert to identify, prioritize and implement solutions. 


My hypothesis is that modernization of Health Care delivery will require a structural change to the existing development processes and paradigms. These changes need to empower clinicians to identify and prioritize industry pursuits, and in turn, allow industry to reduce project risk and emphasize their unique business strengths. I hypothesize that this change will require a unique, specialized clinical resource that acts as a liaison between stakeholders to synthesize, translate, prioritize, and implement efficient solutions on the front lines. To achieve success this resource must be given the power and processes to unite hospitals, clinicians, industry, non-profits, regulatory agencies, and patients in achieving meaningful care experiences. I am excited and thankful to share my voice. And, I am excited to be part of making positive change in Health Care.

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