Need specification v1

Need Specification

BIOE141
Ravi Pamnani
8 October 2012

Always Start with the Unmet Need

“I find out what the world
needs. Then, I go ahead and
invent it.”

Thomas Edison
Decent Inventor
World’s Greatest Need-Finder, Screener,
and Specifier

R. Pamnani Need Specification v1.pptx 2

The Journey to a Need Specification
Spend time with the customer. Observe their daily routine,
Need
become an expert in their problems. Observe the problems in
Identification different settings.

Confirm the need assessment. Interview key opinion leaders,
Need Validation review the literature, ask the following question: Why is this a
problem? Will someone pay for a solution to this need?

Prioritize the needs according to risk (technical, clinical,
Need Screening
regulatory, reimbursement), opportunity (market size,
and Prioritization competition, IP), capabilities of team, etc.

How will you know that you have solved the customer’s need?
Define Customer
Ask them for criteria to determine what results they want (not
Criteria how they wan to achieve the results).

Need Statement
Need Background of Clinical Problem and Market
Specification Evidence Supporting the Need
Description of Customer Criteria
Yock, Brinton. Biodesign Course Lecture, 2009.

Anatomy of a Need Specification

Need Statement Description of
Customer Criteria

Evidence
Supporting the Background of Clinical
Need Problem and Market


Need Statement

A way to

(SOLVE PROBLEM)
(FOR PATIENT POPULATION)
(IN GIVEN SETTING)

in order to

(RESULT IN OUTCOME)


Need Statement Example

A way to

monitor the fluid status
of heart failure patients
at home

in order to

prevent hospital admissions


Objective Outcomes
Desired Outcomes As Measured By…
Improved clinical efficacy Treatment success rates in clinical trials
Increased patient safety Rate of adverse events in clinical trials
Reduced cost Total cost of procedure relative to available alternatives

Improved physician/facility Time and resources required to perform procedure
productivity

Improved physician ease of use Solution of complex workarounds and/or the
simplification of workflow
Improved patient convenience Frequency and occurrence of required treatment,
change in treatment venue (inpatient versus
outpatient, physician’s
office versus home), etc.
Accelerated patient recovery Length of hospital stay, recovery period, and/or days
out of work

Zenios et al. Biodesign: The Process of Innovating Medical Technologies. Cambridge Univ Press 2009.

Background of Clinical Problem and Market

• Disease State Fundamentals

• Existing Treatments

• Stakeholder Evaluation

• Market Evaluation


Evidence Supporting the Need
GAP

• Treatment Gap / Cost-Benefit Analysis

• Economic Burden Analysis

• Market (Patient) Segmentation

• Market Analysis (Size, Structure,
Dynamics)

• Cycle of Care / Flow of Money


Need Criteria
Get into the weeds

Need criteria are the key elements required and/or desired by the
customer

Need Spec Development is an Iterative Process

Observation Research

Need Validation/
Need Criteria
Statement Prototping


Examples of Sources for Need Criteria
• Expert opinion / user input
– One-on-one interviews, focus groups, online surveys
– Physicians, nurses, patients, billing staff, purchasing managers, etc
• Clinical efficacy, safety, and medical best practices
– Meta-analyses / review articles
– Randomized controlled trials
– Case series, case reports
– Preclinical literature
– Textbooks, UpToDate
– Guidelines from Clinical Societies
• Reimbursement/Economic data
– CMS Payment Schedules / Amounts
– Economic/cost analyses (literature, AHRQ, government/Medicare reports)
• Epidemiological data
– Literature, CDC, WHO, etc.


Need Criteria Example – iRhythm Technologies
A better way to detect potential rhythm disturbances in non-
hospitalized patients with suspected arrhythmias

Must haves
• Minimal impact on patient lifestyle and comfort
• Accurately allow physicians to determine if patient’s symptoms are caused
by an arrhythmia
• Ability to monitor and function over extended period of time until
arrhythmia can be ruled out
• Inexpensive

Nice to haves
• External device
• Allows diagnosis of arrhythmia if present
• Have limited to no patient involvement to function
• Ability to correlate symptoms to arrhythmic events

Ear Infections are a Common Problem

• Ear infections result in 17 million office visits each year
• Including 2.65 million Emergency Department visits [2,3]
• 30% of all antibiotic prescriptions for children are for ear
infections [1]
• By age 2-3, 80% of children have had at least 1 ear infection [1]
• Peak incidence is during 6-24 months old

[8]


Typical progression of an ear infection

Eustachian Tube becomes
Child catches a cold
swollen at opening to nose

Fluid begins slowly draining Fluid accumulates in the
(2 weeks - 6 months) middle ear (OME)

Infection subsides Infection spreads from nose
(24 - 72 hours) into fluid in ear (AOM)

Inflammation causes pain

Ear Fluid vs. Ear Infection
Otitis Media with Effusion (OME) = “ear fluid” [1]
”
• Also known as “glue ear” or “serous otitis media”
• Fluid is present in the ear but it is not infected
• Typically precedes and follows an ear infection
• Bulging or full ear drum
• Symptoms = hearing loss (typically 25dB)
• Cloudy and opaque
• Anibiotics will not help • Air-level or bubbles

Acute Otitis Media (AOM) = “ear infection” [1]
”
• Fluid is usually still present
• Middle ear is infected and inflamed causing pain
• Symptoms: otalgia (ear ache), fever, otorrhea (discharge)
• Can resolve on its own, antibiotics has limited effectiveness –
may speed up resolution in some cases • Red or pink ear drum
• Inflamed tissue

Age Condition Treatment
2004 updates by AAP: < 6 month Certain / Uncertain Diagnosis Antibiotics
…but only 15% of pediatricians follow 6 month - 2 years Uncertain Diagnosis Wait and see
this guideline [5]
> 2 years Certain Diagnosis but non-severe Wait and see


Existing Treatment Options
Otitis Media w/ Effusion Acute Otitis Media
• Fluid not infected so antibiotics won’t help
• 80-90% of AOM will resolve on its own
Watchful • Correct diagnosis between AOM vs. OME
• Challenging to convince concerned
waiting [5] can be difficult (pediatricians = 50%
parents with a crying baby to “wait”
accurate; pediatric ENT = 75%)
• N/A unless progresses to AOM • Questionable efficacy: shorten symptoms
• Difficulty in diagnosis and alternatives for by 1 day in 5-14% of children [1]
Antibiotics [4] acute treatment leads to overuse, even in • Antibiotic resistance = top concern for
AOM CDC
• Ineffective for chronic OME (incision closes
• Does not resolve underlying infection,
Myringotomy in a couple of days), but can relieve pain
but may relieve pain symptoms
[6,7] symptoms while a single episode of OME
temporarily while AOM resolves on own
resolves
Laser • Better for chronic OME (incision closes in • Does not resolve underlying infection,
myringotomy several weeks) but still not great, can but may relieve pain symptoms
[7] relieve pain symptoms while OME resolves temporarily while AOM resolves on own

• Ventilates middle ear for 12-14 months –
Tympanostomy • Ventilates middle ear for 12-14 months –
only indicated in chronic OME with hearing
tubes [6,7] only when 3 infections in 6 months
loss

• Can be effective , considered a potentially • Can be effective in reducing pain
Otovent / Ear
effective alternative while waiting and symptoms over time while AOM resolves
Popper [9] seeing, since low cost on own


Typical progression of an ear infection

16 million 650,000

Ear infection onset, Pediatrician visit Antibiotics may be Myringotomy +
significant pain prescribed (even if not Tympanostomy tube
indicated); may or may ENT visit
placement under general
not resolve pain anesthesia

Assuming 2 visits per child, and two ears per child –
325,000 children undergoing surgery / 8 million total children seeking care

~4% of children seeking medical care require an intervention


Need Criteria – Hands-On
A way to relieve the symptoms of ear infections in children with
non-chronic, middle ear fluid that is more effective than
systemic antibiotics.

Must haves
•
•
•
•

Nice to haves
•
•
•


Need Criteria – Hands-On – Example
A way to relieve the symptoms of ear infections in children with
non-chronic, middle ear fluid that is more effective than
systemic antibiotics.

Must Have Nice to Have
• Can be performed without general • Cost less than antibiotic treatment
anesthesia
• Able to be done at the time of diagnosis
• Relieve symptoms more effectively than
• One-time solution
antibiotic treatments (61% resolution
within 24 hours [11]) • Can be done at home
• Cost less than myringotomy ($179 - non- • Causes no pain
facility)
• Causes minimal peri-operative pain
• Tolerable by x% of children
• Skill level: pediatrician

References and Citations
1. Klein. Acute otitis media in children: epidemiology, pathogenesis, clinical manifestations, and
complications. UpToDate 2010
2. Johnson. Pediatric Acute Otitis Media: The Case For Delayed Antibiotic Treatment. J Emerg
Med 2007;32(3):279-284
3. CDC. National Hospital Ambulatory Medical Care Survey. 2005 Outpatient Department
Summary.
4. Tahtinen. A Placebo-Controlled Trial of Antimicrobial Treatment for Acute Otitis Media. NEJM
2011;364(2):116-126.
5. Tarkan. Ear Infections Too Often Misdiagnosed, Then Overtreated. 2/12/2008.
http://health.nytimes.com/ref/health/healthguide/esn-earinfections-ess.html
6. Kerr. Pediatric Tympanostomy Tube Use Steadily Rising; Trend Shows Significant Overuse.
Medscape. 5/4/2009. http://www.medscape.com/viewarticle/702400.
7. Isaacson. Overview of tympanostomy tube placement and medical care of children with
tympanostomy tubes. UpToDate 2010
8. Bhattacharya. Ambulatory pediatric otolaryngologic procedures in the United States:
characteristics and perioperative safety. Laryngoscope 2010;120(4):821-825
9. Otovent® Auto Ear Inflation. Invotec International, Inc. Accessed 9/30/2012.
http://www.invotec.net/otovent.html


Need specification v1

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