Chapter 2: Observation and Needs Identification

1. NEEDS FINDING

2. NEEDS SCREENING
2.1 Disease State Fundamentals 2.3 Stakeholder Analysis

IDEN NTIFY

1.1 Strategic F St t i Focus

1.2 Observation & Problem Identification

1.3 Need Statement Development

2.5 Needs Filtering

2.2 Treatment Options

2.4 Market Analysis

3. CONCEPT GENERATION

4. CONCEPT SELECTION
4.1 Intellectual Property Basics 4.3 Reimbursement Basics 4.5 Prototyping 4.2 Regulatory Basics 4.4 Business Models

INV VENT

3.1 Ideation & Brainstorming

3.2 Concept Screening

4.6 Final Concept Selection

5. DEVELOPMENT STRATEGY & PLANNING

5.1 IP Strategy 5.4 Regulatory Strategy 5.7 Marketing & Stakeholder Strategy

6. INTEGRATION

IMPLEMENT

5.2 R&D Strategy

5.5 Quality & Process Management

5.8 Sales & Distribution Strategy

6.1 Operating Plan & Financial Model

6.3 Funding Sources

5.3 Clinical Strategy 2

5.6 Reimbursement Strategy

5.9 Competitive Advantage & Business Strategy

6.2 Business Plan Development

6.4 Licensing & Alternate Pathways

Process of Observation

Inspiration
Innovators tend to go out and ask doctors what they want rather than observe what they need. When you talk to physicians, as well as others involved, you have got to learn the difference between what they say, what they want, what they will pay for, and what they actually do
Thomas Fogarty, MD g y,

Tom Fogarty MD is among the most prolific and successful medical device inventors Fogarty, MD, inventors. He has been inducted into the National Inventors Hall of Fame, joining the ranks of the Edisons and the Wright brothers

An Overview

Observation

Problem

Outcome

Need Statement
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Process of Observation

Learning Objectives
Differentiate between observations, problems, and needs Understand how to perform, meaningful observations Identify the types of problems that are likely to result in clinical needs

Opportunities for Observation

Opportunities for Observation

Observation and Problem Identification: Fundamentals Clinical observations are a methodology to identify the problems.
Observing a specific clinical situation Identifying a problem inherent in that situation Reshaping ones understanding of the problem into a need Example Observation: A medical resident struggles to intubate a patient in the emergency room, leading to a drop in the patients oxygen level Problem: For an unskilled practitioner, the time required p , q to place an endotrachial breathing tube in an emergency setting can be extensive and can dramatically impact the outcome for the patient

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Going from Observation to Need Statement

An observation statement is a description of a singular event witnessed during a clinical observation

A problem statement describes a recurring situation in which doubt, uncertainty, or difficulty is met in the process of medical care

A need statement defines the change in outcome that is needed to address a given problem i bl

The Biodesign Process for Performing Observations

Basics of Observations: Whom to Observe

Patients Physicians Other healthcare providers (nurses, physician assistants) Family members Administrators Other stakeholders involved in the delivery and/or management of care

Basics of Observations: What to Observe

Problems with the delivery of care Q Question dogma and traditions g Watch for potential problems not just current ones Failures are an important source of information Look-out Look out for competing problems (e.g., accuracy of procedure (e g versus procedure time)

Basics of Observations: What to Observe

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.)? ( t h i l id i l t )? Which constituencies are affected by the problem Patients? With what specific condition(s)? Physicians? In what specialties? The overall healthcare system? In what ways? How many people are included in the affected population? In what ways are they negatively affected (clinical outcomes, safety/risk, inconvenience, recovery, easeof-use, productivity, cost, etc.)? How severe is the effect of the problem? In what setting does the problem occur in physician s office, occur-in physicians office operating room, etc.? During inpatient/outpatient recovery? Anywhere (without notice)?

Ethnographic-Based Research
Identify guiding questions for the observations Identify field sites Get integrated in the field site Supplement observations with follow-up interviews etc. Analyse the data to provide a thesis and an argument Clinical Immersion is the best way to achieve this

Effective Observation Techniques

1. Perform a background research
Understand medical terminology and basic facts related to the clinical situation Understand patient privacy issues and basic medical ethics

2. 2

Become Part of the Team

Shadow the activities of the person or group being observed Get into the mindset of people delivering the care Observe related activities Go with an open mind No attitude of I have already seen this before Observe same procedure multiple times to look for differences

3.

Expect the unexpected

4.

Perform observations in different health care settings

Tremendous variability in how similar problems are handled in various environments

5.

Consider stopping observation process when the same situation is being observed over and over

Ethics in Observation
Be professional Respectful of the approach/limitations of key contact Be sensitive to pri ac related iss es sensiti e privacy issues Remember that it is a privilege for an innovator to gain access to healthcare facility Innovator must gauge when and where to ask questions

Documenting Observations
Capture all observations in an INNOVATION NOTEBOOK Follow these guidelines Choose a bound notebook with numbered pages p g Date and sign each page Have a non-innovator act as a witness p Cross out all blank spaces Record only what is seen Do not filter or classify information p g Capture a large number of observations the more the better Where permitted: take photos or recordings What to document:
Date, time and place of observation Specific facts, numbers, details of what happens at the site Sensory impressions- sights, sounds, textures, smells Specific words, phrases, summaries of conversations, and insider language g p process Timings of various steps of p Questions about people or their behavior to be investigated later

Observation

Understanding the problem

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Uncovering Problems through Observations

To understand problems: While conducting observations, the innovator must keep in mind the multiple perspectives of all those who are involved in the delivery of care

Observation to Problem Statement

Example Observation: A hospital janitor drops several loose contaminated needles as he is depositing them into a plastic garbage bin and is forced to pick bin, them up by hand. Problem: An accidental needle stick could expose the janitor to infectious body fluids (HIV, hepatitis)

Clues for Identifying Problems that may Lead to Clinical Needs

Certain types of events and behaviors can serve as clues that may be of indicative of a significant problem. These clues need to be investigated further as they often lead to identification of important clinical needs.

From Patient Perspective Pain Death Stress

From Provider Perspective Risk Malfunction Uncertainty Dogma

From System Perspective Cost Inefficiency

The Patient Perspective

The Provider Perspective

Other Perspectives

Objective Outcomes
Desired Outcomes Improved clinical efficacy Increased patient safety Reduced cost Improved physician/facility productivity Improved physician ease of use I d h i i f Improved patient convenience As Measured By Treatment success rates in clinical trials Rate of adverse events in clinical trials Total cost of procedure relative to available alternatives Time and resources required to perform procedure Solution f S l ti of complex workarounds and/or l k d d/ the simplification of workflow Frequency and occurrence of required treatment, change in treatment venue (inpatient versus outpatient, physicians office versus home), etc. Length of hospital stay, recovery period, and/or days out of work

Accelerated patient recovery

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Developing a Need Statement

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Learning Objectives
Learn how to translate a problem into a clinical need statement that is accurate appropriate in scope and solution independent accurate, scope, solution-independent Understand the importance of targeting a specific outcome in a need statement Learn th pitfalls associated with d L the itf ll i t d ith developing a poor need statement l i d t t t Recognize the different categories of need statements and how these may relate to solution risks and benefits

Developing a Need statement

Isolate the single need that has the best chance of addressing the problem, driving a desired outcome, and supporting a reasonable market opportunity Capture need in one sentence statement Focus on goal or endpoint, not problem Do not reference current solutions!

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Refining the Needs Statement

Scoping
PrelmininaryNeedStatement

Validation

RefinedNeedStatement

NeedSpecification

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Pitfalls to Avoid
Embedding a solution within the need Statement should address WHAT change in outcome is needed not HOW the problem will be addressed pp p p Inappropriate definition of the scope Too narrow or too broad
Example: A way to prevent or decrease the incidence of infections associated with hip implants in the elderly A way to decrease the incidence of infections associated with joint implants in the elderly

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The Effect of Embedding a Solution Within a Need

Need Statement Scoping

Could this problem exist within a larger patient population? Could this problem exist within a subset of the patient population? Could you be more specific in addressing the need? Could you more broad in addressing the need?

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Need Statement Scoping

Change to indian example A way to revascularize heart muscle without access morbidity.

A way to perform CABG without sternotomy A sternotomy.

A way to close sternotomy quickly and securely.

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The Biodesign Process for Developing a Need Statement

Different Types of Needs: Incremental vs. Blue Sky

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Superseding Needs and Related Solutions

I find out what the world needs. Th I go ahead and d Then h d d try to invent it.- Thomas Edison

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Needs Finding: Case Examples CHCF Workshop p Sept 30, 2010

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Example: The problem of screening for anaemia in pregnant women in rural India.
Observation: During a visit to rural health centre, it was observed that pregnant women rarely come for their mandatory ante-natal/pregnancy checkups. The y p g y p health worker who does home to home visit finds is difficult to difficult to objectively identify the anaemics amongst the pregnant mother. Problem Statement: Anemia is very common condition in pregnancy. It is usually due to nutritional causes. If anaemia is not detected promptly it can result in maternal mortality Presently a blood prick is mortality. required to measure hemoglobin in blood in detect anaemia, but patients have to often travel long distances to the nearest PHCs to their blood test done. done Very often the pregnant women do not turn at often, the health centre for their ANC checkups Need: An objective and easier way to screen for anaemia amongst pregnant women that does not involve a blood test.

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Example: Management of lower limb trauma

Observation: Road traffic accidents(RTA) are very common in India. Every year about 15 million patients suffer from lower limb injuries due to RTAs. These patients are often transported to hospitals/clinics in an inappropriate manner. Problem Statement: Most of injuries due to an accident are aggravated because of inappropriate transport/transfer to patients to the hospital. Also most of these patients have to wait in the hospitals for a long time till they get treated by an orthopedician. It turns out early immobilization of an injured limb can promote healing and prevent further aggravation. Need: A better/reliable way to immobilize the lower limb in trauma patients before they receive definitive care.

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Example: Problem of elderly fall

Observation: It was observed that many elderly people fall when getting up from bed/from a sitting position Problem Statement: Elderly people fall because of a variety of reasons. But the y most common situation is while getting up from a stationary position because they arent able to exert force to lift themselves up and dont always find don t anything accessible to hold onto for support.

Need: A way to prevent elderly falls while getting up from a stationary position that doesnt require them to exert too much force.

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Example: Hand Sanitization

Observation: During a physical exam, the physician examines the oral cavity of a patient with bare hands He then goes hands. to the next patient and examines him without cleaning his hands. Problem Statement: The physicians hands are contaminated after the first examination and he ends up transmitting the infection t another patients if h th i f ti to th ti t he doesnt comply to hand-hygiene protocols.

Need: A way to improve hand-hygiene compliance among healthcare professionals in order to reduce healthcare-associated infections.

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Summary

Observe broadly and deeply Think through each observation and try to understand the underlying problem Need scoping is critical to the development of a need statement Do not embed solutions in your need statement statement. Keep iterating on your need statement till you get it right.

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Practical session/Lab
Visit to a nearby hospital/clinic
Follow the observation guidelines Record Your observations in the innovation book Show your observations identify the associated problem and darft observations, the corresponding need statement by ___ (date).

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