Post on 01-Mar-2021
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