1.2 Needs Exploration

Reflections from an Observation: Optimizing the Experience

Biodesign Fellows discuss ways in which an observer can optimize the experience in the clinical setting in order to gain the most insights.

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The Observation Experience

Members of the Biodesign Fellowship discuss what it’s like to conduct clinical observations.

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Observation Dos and Don’ts

Tom Krummel, Chair of the Department of Surgery at Stanford, shares tips and pointers for conducting effective and respectful clinical observations.

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Getting Started

When performing needs exploration to uncover important clinical problems, use the following steps as a guide.

Perform Background Research

What to Cover

Use what has been learned to choose a strategic focus as the starting point for additional research. Get smart about the disease state, treatment options, stakeholders, and market in enough detail to be knowledgeable and informed during observations and interviews. Understand the environment in which care is delivered and, in turn, where observations will be conducted. Assess the level of conservatism in the location’s policies and be sensitive to concerns related to HIPAA and other relevant regulations. Prepare a list of guiding questions to investigate, be prepared to engage in a meaningful, educated discussion about what is observed. Always keep an open mind.

Where to Look

Primary Research – Individuals within the field can be an excellent source of information, even if they do not grant the innovator access to perform observations. Talk with these people informally about their work in an effort to prepare for observations. Just be careful not to let their perspectives and opinions bias the observation process. It can also be helpful to talk with others who have performed observations in the past regarding their experiences, how they handled themselves onsite, and the lessons that they learned.

Literature Review of Clinical Problem – Review information about the chosen strategic focus area through sources such as:

  • Harrison’s Online – Contains the complete contents of Harrison’s Principles of Internal Medicine.
  • Medical ReferencesGuyton’s Textbook of Medical Physiology or another standard medical textbook will provide valuable, credible, and detailed information.
  • PubMed – PubMedis a database of the U.S. National Library of Medicine that includes more than 16 million citations from MEDLINE and other life science journals back to the 1950s. General reviews will be particularly helpful in understanding pathophysiology (locate Reviews by selecting this type of article under the “Limits” tab from the main page of the site before beginning a search).
  • Up-To-Date – A database of evidence-based clinical information.
  • eMedicine – Clinical knowledge base with more than 10,000 physician authors and editors.

Set Up Observations

What to Cover

Observations can be performed with patients, physicians, other healthcare providers (nurses, physician assistants), third-party payers, facility administrators, procurement staff, and other stakeholders involved in the delivery and/or management of care. Innovators should determine which ones are the most relevant and then tap into their personal networks to gain permission to conduct observations. Refer back to the defined strategic focus to make sure that the chosen contacts and field sites will provide information aligned with the area of interest. If possible, try to find varied settings in which to conduct observations. Many hospitals are part of larger integrated healthcare networks, which may be a mechanism for accessing other clinical settings.

Where to Look

Innovators should look for contacts within the colleges and universities with which they are affiliated, particularly if they have an on-campus medical school. Personal or family physicians can be contacted for leads. Friends, family, and neighbors may be able to make introductions. Business associates with investments in healthcare-related companies and products may also be able to provide contacts. Cold calling, while sometimes frustrating, can be effective, especially when no other contacts have been identified through networking.

Conduct Observations

What to Cover

Work hard to become embedded within the team. Perform rounds with physicians and shadow them “on call” in an effort to better understand the culture of what they do and the environment in which they do it. Pay careful attention to the clues that may signal problems with the delivery of care. View problems through different perspectives to uncover new ways of thinking about the core issues. Also, during the observation process, remember to:

  • Ask questions, but do not be constrained by what individuals say their problems are. Do not hesitate to question dogma.
  • Watch for latent problems. Many times, the greatest issues are those that are not yet recognized.
  • Keep in mind that failures are an important source of information. Investigate what is most likely to go wrong and find out what can be learned from these failures.
  • Be on the look-out for competing problems (e.g., accuracy of procedure versus procedure time) and seek to understand what drives these tensions.

Where to Look

Observers should exercise their best judgment regarding when and how to embed themselves within the team and the approach they take to conducting observation. In addition to watching for clues that can signal problems, observers should be aware of and respond appropriately to verbal and non-verbal signals from the team regarding the observer’s presence. Maintain the utmost professionalism and discretion at all times.

Document Observations

What to Cover

Create an innovation notebook and take detailed and copious notes regarding what is observed. Do not filter or editorialize when recording what has been seen. Record the date, time, and place of all observations; specific facts, numbers, details of what happens at the site; sensory impressions; personal responses to the fact of recording fieldnotes; specific words, phrases, and insider language; summaries of specific conversations; and questions about people or behaviors at the site for future investigation. Based on HIPAA rules, do not record patient identifying information (e.g., medical record number, social security number, etc.).

Where to Look

Refer back to the information provided in the chapter for important guidelines about maintaining an innovation notebook.

Refine Problems/Insights through Interviews

What to Cover

As the idea-flow begins to wane, begin prioritizing and evaluating the problems that have been observed and the key insights associated with them. The critical output from this step is an understanding of the most compelling problems/insights and how the innovator or team prioritizes them. Conduct additional research and observations to test and triangulate this information. The intent of this step is to ensure that the problem/insight is supported by multiple data points. Ask questions such as:

  • Why does the problem occur? What are the possible explanations and causes for the problem?
  • What are the medical implications of the problem (anatomy, physiology, epidemiology, etc.)?
  • Which constituencies are affected by the problem¾Patients? With what specific condition(s)? Providers? What type, and in what specialties? The overall healthcare system? In what ways?
  • In what ways are they negatively affected (clinical outcomes, cost, safety/risk, inconvenience, recovery, ease-of-use, productivity, cost, etc.)?
  • How severe is the effect of the problem?
  • In what setting does the problem occur¾during procedure in physician’s office, operating room, etc.? During inpatient/outpatient recovery? Anywhere (without notice)?

These questions can also be asked of stakeholders in the environment, but be careful to recognize potential biases in their responses. Summarize the most important data gathered. Remember, it is still too soon to begin thinking about solutions. While this can be frustrating to entrepreneurs and innovators, they must resist the tendency to allow “solution biases” to taint their understanding of the problem (for more information, see 1.3 Need Statement Development).

Where to Look

Refer back to the sources listed above to perform additional, focused literature searches. Talk with stakeholders in the environment where observations have been conducted. Schedule additional observations with new or existing contacts. Seek input from advisors, as needed.