Copyright 2010 by the Board of Trustees of the Leland Stanford Junior University. All rights reserved. NEEDS-W10-101210.

Biodesign Innovation: Needs

As a service to the biomedical engineering education community, the Stanford University Biodesign Program is offering clinical need statements that have been identified through our Innovation Fellowship. These needs are derived through direct observation by our fellows in local hospitals and clinics. The process of needs finding is documented in the Biodesign textbook and should be referred to when considering the use of these needs in a course on Medical Devices.

The needs have also gone through a filtration process that is further described in the textbook. However, the needs included herein have not been validated. We leave this step as an exercise for your students, just as is done in the Biodesign Innovation course at Stanford University. Although our students taking the class do not observe the need first hand (that is done by our fellows), they are still required to validate the need prior to developing solutions just as they would if they had identified the statement themselves. Because these statements are created after only one or two observations, many of the need statements require revision to be accurate and this becomes clear after a proper validation has been conducted. In a few rare cases the need as stated is incorrect and does not truly exist. Thus, the validation exercise is to determine which initial need statements are good as stated, which require revision to be correct, which are fundamentally flawed.

Included below is the list of the top 12 needs from the fellows as well as slides that they used to present these needs in the Biodesign Innovation course.

Usually each student is assigned only one need to work on to make this determination. Needs that are validated become the substrate for the team efforts that follow this step.

It is our hope that you will use these needs in that way, having your students validate them prior to using them for potential device solutions. We refer you to the textbook chapters 1. 3 and 2.1 - 2.5 for further information on those steps of the Biodesign Process.

We hope these are helpful to you in your educational initiatives. Please feel free to let us know how useful these are to you in your course(s).

The Biodesign Faculty

from slides at ebiodesign.org

Copyright 2010 by the Board of Trustees of the Leland Stanford Junior University. All rights reserved. NEEDS-W10-101210.

Biodesign Innovation Top Needs, 2010

1. A better way to prevent pressure ulcers in non-ambulatory patients.

2. A better way to treat acute thrombosis in acute limb ischemia (ALI) patients in order to decrease hospital length of stay.

3. A better way to permanently exclude the abdominal aortic aneurysm (AAA) sac from blood flow.

4. A better way to prevent post-operative bleeding complications in percutaneous vascular procedures requiring large caliber openings.

5. A way to safely increase harvest-to-implant time for organ transplant procedures.

6. A better minimally-invasive treatment for hypertrophic cardiomyopathy (HCM.)

7. A way to prevent X-ray exposure to catheterization laboratory workers to reduce lead encumbrance.

8. A way to permanently improve cosmetic appearance in port wine stain patients.

9. A way to prevent peri-operative distal embolization in carotid stenting procedures.

10. A better method to reduce time spent in arrhythmia in patients with paroxysmal atrial fibrillation.

11. An outpatient method to detect heart failure decompensations in order to prevent CHF hospitalizations.

12. A faster and more efficacious method to alleviate ischemic symptoms related to coronary chronic total occlusions (CTO.)

A better way to prevent pressure ulcers

in non-ambulatory patients.

» Background: » Pressure ulcers form when a portion of skin breaks down as a

result of constant pressure against it, reducing blood supply to the

area

» Current prevention methods include regular skin inspection,

specialty beds/mattresses, nutritional modifications are suboptimal

(still 10-15% of all acute care patients), and costly ($40-80/day)

» Pressure ulcers cause higher costs (treatment and LOS), and

increased morbidity and mortality

» As of 10/2008, new CMS guidelines state that hospitals will no

longer receive additional payment when pts develop stage 3-4

pressure ulcers

» Market

» Incidence: >1,000,000 ulcers/yr which costs US >$1.3B annually.

Each ulcer costs $4k – 40k to treat

» Specialty beds/support services = $2B (CAGR 3-16%)

Red Team: Needs Presentation

http://www.ahrq.gov/clinic/ptsafety/chap27.htm

A better way to treat acute limb

ischemia (ALI) in order to decrease

hospital length of stay.

» Background:» ALI is a rapid or sudden decrease in limb perfusion that threatens tissue viability.

» Caused by an embolism, thrombosis, or trauma.

» ALI due to thrombosis is associated with long and costly

hospital stays, amputation, and mortality.

» Observation: » 55 y/o male had clot in subclavian.

» Needed 3 cath lab days including 2 angioplasties and 1

thrombolysis treatment to dissolve clot.

» Market:

» 45k US patients per year.

Red Team: Needs Presentation

A better way to permanently exclude

the abdominal aortic aneurysm (AAA) sac

from blood flow.

»AAA rupture leads to 15k deaths and has

90% mortality

»Vascular grafts have $1B market, but

have complications

»5% mortality risk

»Graft leakage and AAA growth

»Required yearly follow up

»Opportunity exists to save patient lives

and improve healthcare efficiency

Red Team: Needs Presentation

A better way to prevent post-operative

bleeding complications in percutaneous

vascular procedures requiring large caliber

openings.

»Constant improvements in percutaneous

vascular procedures (ex, valve replacement)

»More complex procedures lead to

increased complications

»Vascular closure market = $700M and

growing

»Though there are many products, problem

still unsolved

Red Team: Needs Presentation

A way to safely increase harvest-to-

implant time for organ transplant

procedures.

» Background: » Worldwide, over 85k people are on a list for organ transplant

and only 21k transplants are performed per year.

» 15% of available organs are not used due to suboptimal

status.

» Finding the optimal donor/recipient match is compromised

due to geographic constraints as a result of tight organ

preservation windows.

» Observation: » 60’s male recipient received female heart due to urgency and

proximity

» Statistically this off-gender match has a high failure rate

» Market:

» 21k organ transplants worldwide per year

» 3k heart transplants worldwide per year

Red Team: Needs Presentation

A better minimally-invasive treatment

for hypertrophic cardiomyopathy (HCM)

» Background:

» Often associated with thick septum and/or mitral valve abnormality

» Can lead to systolic dysfunction and remodeling, usually leading

to heart failure.

» Many patients managed medically, but no good data showing

improved outcomes.

» Gold Standard: Myectomy – An open procedure to remove part of

the ventricular septum and/or mitral valve replacement.

» ETOH ablation is less invasive alternative to Myectomy

» Observation:

» 30 y/o male gets ETOH ablation

» Physician is unsure if treatment reached all of the necessary

tissue, procedure repeated after echo

» Physician complained that he ablated too much tissue.

» Market:

» 100k HCM patients

» 50k are symptomatic

Red Team: Needs Presentation

A way to prevent X-ray exposure to

catheterization laboratory workers to

reduce lead encumbrance

»Continuous X-ray (fluoroscopy) is

ubiquitous in the catheterization laboratory

»Lead aprons are 20 pounds and must be

worn for the duration of the procedure

»Aprons limit physician’s physical access

to the patient

»They have been shown to increase the

incidence of chronic back pain

»An opportunity exists to change

paradigm of cath lab procedures

Red Team: Needs Presentation

A way to permanently improve

cosmetic appearance in port wine stain

patients.

» Background:

» A port-wine stain is a birthmark in which swollen blood

vessels create a reddish-purplish discoloration of the skin

» Most often on the face, but other locations also possible

» Most effective treatment: laser therapy, particularly Pulsed

Dye Laser (PDL)

» However, multiple treatments are required and they are not

permanent. Lifelong maintenance laser treatments are

required for this progressive disease.

» Observation:» 24M patient with port wine stain over eyelid required 11 PDL

treatments and there was still some discoloration over eye

» Market:

» 3-5 out of 1000 people have port wine stains at birth

Red Team: Needs Presentation

A way to prevent peri-operative distal

embolization in carotid stenting procedures.

» Background:

» Carotid arteries located on each side of neck, providing blood

flow to brain

» Plaque buildup increases risk of ischemic stroke and transient

ischemic attacks (TIAs) due to embolism

» Two primary treatments: 1. Carotid endarterectomy (CEA), and

2. Carotid stenting

» After stenting, most pts are clinically asymptomatic, but 20-

50% will have some degree of brain ischemia

» 30-day post-procedure risk of stroke or death is 6-12%, even

with the use of embolic protection devices

» Observation:

» 71M patient undergoes carotid stenting procedure and two

days later experiences stroke resulting in permanent vision

loss in one eye.

» Market:

» Carotid stenting procedures performed (2007): 15,235

» Annual cost impact of stroke: >$250M (est.)

Red Team: Needs Presentation

A better method to reduce time spent

in arrhythmia in patients with paroxysmal

atrial fibrillation.

» Background:

»Atrial fibrillation is the most common cardiac

arrhythmia.

»Atrial fibrillation is a major risk factor for

stroke, heart failure, and independent risk factor

for mortality.

»Treatment options: antiarrhythmic medications

and atrial fibrillation ablation

» Observation/Problem:

»Antiarrhythmic medications are associated wth

significant toxicity and side effects.

»Catheter ablation is only 70-80% effective

» Market: ~2.5M patients in U.S. with AF

White Team: Needs Presentation

An outpatient method to detect heart

failure decompensations in order to

prevent CHF hospitalizations.

»Background:

»Patients with a history of congestive heart

failure are managed with a combination of

medical and device therapy.

»Chronic outpatient management can control

symptoms and reduce mortality risk

»Observation/Problem:

»Decompensations (symptoms: fluid retention

and shortness of breath) still occur frequently

and can lead to lengthy hospitalizations.

»Market:

»3.5M annual hospitalizations for congestive

heart failure account for ~$10B in health care

spending.

White Team: Needs Presentation

A faster and more efficacious method to

alleviate ischemic symptoms related to

coronary chronic total occlusions (CTO)

»Background: CTOs completely block vessels with

firm plaque which leads to ischemic symptoms

(chest pain, reduced heart function)

»Observation: 60 min to maneuver current device.

Too bulky to cross lesion resulting in unsuccessful

procedure even with the use of multiple wires.

» Problem:

»Success rates of recanalizing CTOs: 47-72%

»Requires greater skill, longer case time

»Technology development has not increased

success rates

»Significance: +150k CTO procedures annually

30% of all CAD patients have CTOs,

All complications rate: 6.8% to 20%

White Team: Needs Presentation