By Reece Burns

    The root of all technological and medical advances can be traced back to observation and problem identification, or “finding a need.” Finding a need may not occur in all medical technology advances in a formal sense but for any new ideas or startups, some iteration of need finding will be necessary to present to investors or those impacted by the innovation. Also, using a needs-based approach prevents the pitfall of creating a technically interesting but practically useless device. Designers must first begin by picking an area of focus to guide their efforts. Usually, businesses and healthcare workers are open to having observers who have the goal of improving their day-to-day workflow or processes. As such, having clear goals and a mission as a designer and team maximize efficiency and enable you to make focused observations. A mission statement can help ground a design team and help guide their research back to what was agreed upon as important, or not important. It does not need to be complex but can be as simple or as expansive as desired. Likewise, other aims around the main goals can be helpful to clarify, such as the timeline of the project, the intended customer-base, who they hope to help, and how much the end product should cost. For example, one can search big medical company mission statements to help guide them, keeping in mind that major corporations will likely have a much more involved mission statement than is needed for start ups. 

    Another aspect of creating these goals that must be considered is the market size of the field. Can the current and projected markets support your innovation to provide stability and longevity to your company? Additionally, if the target market is large, there could be well-established companies and practices in the field that may make entry difficult for newcomers. 

    Another consideration when thinking of goals is the geographic target. Is the goal local, national, or global reach? Every country has a different market and different standards and regulations for medical innovation approvals and this may or may not be important to a design team in the beginning.

After the above has been addressed, the needs-finding process is often started with observing facilities and their employees during day-to-day workflow. The overall goal is to identify a problem or struggle, determine who it involved or affected, and determine what the ideal outcome would be. In short: Observe, identify problem(s), identify the population involved, determine the ideal outcome or solution. 

    It can be difficult determining what is and isn’t a problem. Often, it helps to think about the indicators in which a clinical need may be present. Such indicators include times when a patient experiences pain, death, stress, risk, or when providers experience risk, malfunction of a device, uncertainty, cost, or inefficiency. Once multiple observations are made, patterns and repeat instances may begin to appear, at which point more common and more important problems may become more transparent. It may be helpful to put yourself in the perspective of different stakeholders (eg, patients, providers, hospital administrators, etc) when thinking about areas for potential improvement. 

Once you’ve focused on some areas of interest, try to approach observation with a genuine curiosity about the process. Note patterns of practice and ask more questions about them and note inconsistencies in what you see and what you hear, as both are often areas that have opportunities for innovation.  Listen and absorb everything you can about the processes of interest. Try to gain insight about the process before, during, after its direct use so that you can understand difficulties or inefficiencies at any point. Often sitting down with the people observed after the experiences and asking questions and having a conversation about what you saw can help identify problem areas that may not have been appreciated during observation. You’re going to be in this stage for a while. It is advisable to keep a notebook of your observations and journal thoughts to prevent forgetting them. It’s also important to have documentation so that you can contribute to your team meetings accurately and have a record of your participation. 

    Once you’ve identified a problem, it’s important to investigate the values of the company or field you are trying to improve. Values in this sense refer to what the field finds important enough to be worth investment (e.g. keeping a patient out of the hospital, shortening stays, reducing risk of procedures).

A need statement is the next step of the project process, and it can be challenging. A need statement that is too specific may result in failure if you are unable to meet the exact parameters desired and also limits potential solutions. For example, the need for a better way to access the inside of the chest is a broader need statement than the need for a better way to perform sternotomy. The former statement may result in the development of minimally invasive thoracic surgery while the latter statement may result in a better saw. However, too broad of a need statement may make it difficult in producing a solution that addresses the problem(s) effectively and are considered more risky since there may be more complicating factors involved. It is important to remember not to include potential solutions in the need statement. 

Observation may also result in multiple need statements and problems as well. Please see our article on Pugh charts to learn how to take into consideration multiple needs and problems, but ultimately, the most impactful need will be the one companies, employees, physicians, and investors will support. In this article, we hope to have introduced you to the concept of needs statements and how observation can be performed to identify problems that may provide potential opportunities for innovation and improvement. This is the first step in the Biodesign process.