7. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Endovascular
Peripheral Grafts
ePTFE Vascular Graft
Textile Vascular Grafts
Collagen Coated PET
NiTiNOL stent
OEM - Sewing cuff
Heart Valves
Annuloplasty rings
Scaffolds for
Tissue engineering
Mesh
for Hernia Repair
Traditional Biomaterials in Devices
Coils
Brain Aneurysms
Prosthetic joints
Bone repair - bone
plates
Vertebroplasty -
Bone cement filling of
Compressed vertebrae
8. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Percutaneously
placed endovascular
Stent
New Generation DevicesNew Generation Devices
GDC
®
Coils
Brain Aneurysms
Drug
eluting &
Bioaborbable
stent
Injectable Polymer: endoscopic
therapy for GERD
Uterine Sling -Repliform ®
Tissue
Regeneration Matrix, human dermis
architecture w ith cells removed
Injectable Bulking Agent for stress urinary
incontinence, Non-Migratory
pyrolytic carbon-coated beads, 212 to
500 μm
Control of Wound
Healing
Scaffolds for
Tissue engineering
Bioactive and
Bioresorbable Fabrics
9. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Patient Receives 3D Printed Implant To
Replace 75 Percent Of Skull
…a radical surgery was performed on an American patient: 75 percent of his skull
was replaced with a 3D printed implant.
The company that produced the implant, Oxford Performance Materials, made the
announcement though offered little detail about the patient or the procedure. The
surgery was given the green light by the Food and Drug Administration in February.
The implant is called the OsteoFab Patient Specific Cranial Device (OPSCD) or
OsteoFab for short and is made from polyetherketoneketone (PEKK) thermoplastic
through an additive manufacturing process.
http://singularityhub.com/2013/03/28/patient-receives-3d-printed-implant-to-
replace-75-percent-of-skull/
10. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
3-D Printed
Metallic Devices
http://nsf.gov/discoveries/disc_summ.jsp?
cntn_id=129867
11. MEDICAL DEVICE VALUE CHAIN
Bench/
Anim
al
Testing
D
istribution
Clinical
Application
Com
ponents/
D
evices
• Powders
• Dispersions
• Coatings
• Composites
• Biomaterials
• Proteomics
• Genomics
Formulation Fabrication Integration
Synthesis Modification
Separation,
Purification
Clinical
Trials
RawM
aterials
Technology Medicine
Develop IP Strategy: Composition of Matter Applications
File IP
15. Technology Investment & Risk
Research
• Studies & Analysis
• Lab-Scale Demos
Cost
Risk
Manufacturing &
Commercialization
• Technology Transfer
• Production Line Layouts
• Production Prove-out
• System Integration
• Distribution & Deployment Logistics
Engineering &
Development
• Technology Assessment &
Evaluation
• Manufacturing Assessment
• Product Prototyping
• Pilot-Scale Demos
• Process Models
• Production Simulations
• Quality Control
• Life Cycle Assessments
Technology Maturity
16. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Trends:Trends:
Younger patientsYounger patients
requiringrequiring
longer termlonger term
performanceperformance
requirements!requirements!
The Wall Street JournalThe Wall Street Journal
Fri. Aug 22, 2003Fri. Aug 22, 2003
17. Challenges of Developing Medical
Technology
Clinical Centers
Investors/ROI
Physician
Collaborators
IP Strategy
Competition
Resource Limits
M&A and
Downsizing
Regulatory
Strategy
Commercial
Lifetime
Technical
Challenge -
Design Intent
Bundled Insurance
Reimbursement
18. Will bundled payments hurt healthcare innovation?
Written by Helen Adamopoulos | October 25, 2014
Bundled payment models —which involve a set price
intended to cover each element of clinical care or support
for a specific procedure or condition — could prove an
effective way for the care providers to contain costs while
improving quality. However, some healthcare industry
stakeholders have raised concerns about a possible
downside to bundling payments: stifling innovation.
19. Identification of Drivers for New
Technology
• Cost Containment/Bundled Reimbursement
• New Diagnostics and Point of Care
• Infectious Disease
• Epidemic/Pandemic Surveillance
• Biomarkers for Disease
• Enablement for interventions: e.g.
vulnerable plaque
Personalized
Medicine
20. • New Therapeutics
– Cancer
– Infectious Disease
– Immune Disease
– Minimally/Less Invasive Procedures
– Implants
– Tissue Engineering/Cell Therapy
Drivers for New Technology cont.
21. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Leverage Potential Disruptive Technologies
Drug Delivery
Therapeutic Polymers
Biodegradables
3D Printing
Tissue Engineering
Stem Cells
Smart Materials
Imaging, e.g. Molecular Imaging
Genomics
Proteomics
Glycomics
Computation
NanoStructures
MEMS, eg CardioMems
Telemetered/sensored implants
22. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Leverage ongoing Advances
•Bioabsorbable stents
•Robotically assisted surgery.
•Less invasisve cardiac surgery, eg Transcatheter valve implantation
•Tissue Engineering & Stem Cell transplants: potential for stroke recovery;
tendon grafts; CHF; Blood Vessel replacement; bone grafts; nerve regrowth
•Capsule endoscopy for diagnosis of GI disorders
•Genomics-based Clinical Trials
•Gene Editing using CRISPR
•Cell-free Fetal DNA Testing
•Cancer Screening via Protein Biomarker Analysis
•Naturally Controlled Artificial Limbs
•Remote Monitoring (Wearables)
•Neurovascular Stent Retrievers (Clot Removal)
Modified from AHA top ten innovations and CCF top ten
innovations
23. •The bridge to commercialization
• Proof of principle in a clinically relevant setting
• Drivers for Development
• Cost Containment, New Therapies, New
Diagnostics and Point of Care Medicine
•Intellectual Property
Commercializing
24. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Sustainablility of Medical Therapuetics
Sustainability of US healthcare delivery
- return patient to active member of society
How to develop highly efficacious and safe technologies
- reduction of acute health costs
- reduction of chronic health costs
-- infection
-- heart disease
-- cancer
-- dementia
25. Personalized Medicine to Drive New Technology
Less Invasive Therapies
Custom Implants
Biosensors
Implantable biosensors, eg CHF
Telemetered devices and implants
Molecular Diagnostics
Genomic basis of Disease
Local and Targeted Drug Delivery
Pharmacogenomics
Tissue Engineering
Cell Therapy
New Imaging, eg. Histologic Grade
OCT
Personalized Medicine:
Local and Targeted
Diagnostics and Therapeutics
to allow “individualized
treatment for each patient”
26. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Interventional Placements
of Implantable Devices and Treatments
e.g. CABG, Heart Valves, Joints
Tissue Engineered Constructs, Chordae Tendon
Repair, Biodegradable
Injectables for Heart Failure
Implantable Sensors
Functionality
Time
SurgicalSurgical
Interventional/Interventional/
MIS -MIS -
Stents , HVsStents , HVs
ImplantableImplantable
SensorsSensors
Disruptive Technology: Surgical Procedures
GenomicsGenomics
Identifying EffectiveIdentifying Effective
TherapiesTherapies
28. The bridge to commercialization
–Proof of principle in a
clinically relevant
setting
29. PRODUCT LIFECYCLE FOR MEDICAL
DEVICES
Bench/
Anim
al
Testing
D
istribution
Clinical
Application
Com
ponents/
D
evices
Clinical
Trials
RawM
aterials
30. Medical Device Market
• Device Company Aggregate Top line 11%
annually
• from 1995-2005
• R&D Funding at 10.3 % of sales
• Compound Annual Growth Rate – CAGR
15.3% compared to Pharma at 6.7% and
S&P at 6.0 %
• 510K’s in 2006 – 3,210 2015 -- 3006
• PMA’s in 2006 - 39 2015 – 48 original
958 supplements
P. LAWYER, J. P. ANDREW, M. GJAJA, AND C. SCHWEIZER, PAYBACK II: MEDICAL DEVICES RIDE
THE CASH CURVE IN VIVO: THE BUSINESS & MEDICINE REPORT | March 2007
31. Medical Device Market – Examples of Cash Curves
510K A 510k B PMA
R&D Costs
$ 0.25M $ 2 M $80M
Regulatory Approval and Time to
Market
15 mos 27 mos 15 mos
20% Operating Profit 30%
2yr life 6 yr life 8 yr life
$1.6 M pk sales $5.4M $215M
32. • PMA’s have high cost of failure
• Creating markets for niche products
• Leverage the physician and medical
center
• Cost Containment
• Reduced downstream health costs
• Improved safety and efficacy
Medical Device Market – Challenges
33. Sustainability of Medical Therapeutics
Introduction to Biomaterials
Identification of Drivers for New Technology
- Leverage Potential Emergent/Disruptive Technology
- Sensors for Personalized Medicine
Biocompatibility as a design requirement of medical devices
- Coatings/Surface modification
- Next gen bioactive materials
Bioprosthetic Tissue and Tissue Engineering
Combination Devices
Drug Eluting Stent
34. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Traditional Definition:
Personalized Medicine
'The molecular methods that make personalized medicine
possible include testing for variations in genes, gene
expression, proteins and metabolites, as well as new
treatments that target molecular mechanisms. Test results
are correlated with clinical factors - such as disease state,
prediction of future disease states, drug response, and
treatment prognosis - to help physicians individualize
treatment for each patient'
Personalized Medicine Coalition
www.personalizedmedicinecoalition.org/sci
encepolicy/personalmed-101_overview.php
35. Broader Definition of Personalized Medicine
Local and Targeted Diagnostics and
Therapeutics to allow “individualized
treatment for each patient”
38. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Setting Expectations
How to innovate while addressing concerns.
Suggests need to establish well delineated practice
guidelines as the technology translates into the
clinic
(CNN) – Cancer breakthrough -- or nightmare?
January 11, 2011
“A simple blood test. It's able to detect minute quantities of cancer cells
that might be circulating in your bloodstream.
It's reported to be able to detect a single cell. It's intended to allow
cancer patients to start treatment much earlier.
It's supposed to save lives. It's a cancer breakthrough.
But it's not that simple. The test could just as easily start a cancer
epidemic.”
39. Personalized medicine. Personalized medicine includes the detection of disease
predisposition, screening and early disease diagnosis, prognosis assessment,
pharmacogenomic measurements of drug efficacy and risk of toxic effects, and the
monitoring of the illness until the final disease outcome is known.
JS Ross, GS Ginsburg, The Integration of Molecular Diagnostics With Therapeutics
Jeffrey S. Ross, MD, Geoffrey S. Ginsburg, MD, PhD American Journal of Clinical Pathology. 2003;119(1)
http://www.medscape.com/viewarticle/447846
40. This is Siri. We
have news for you.
You appear to be
dead!!!
Patients will be monitoring their own health with
Smart phone sensors and apps. They will be
taking control of their own health before they
even see the Dr.
41. Mobile Digital Health
The smartphone has built-in sensors for monitoring heart rate, pulmonary function, blood sugar
levels, body temperature and more.
https://www.lifewatch.com/
http://www.wsj.com/articles/the-future-of-
medicine-is-in-your-smartphone-
1420828632
42. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Next Gen Sensors will drive the thrust for
the evolution of personalized medicine and
on demand therapy to mitigate adverse
events as they happen:
- implantable sensors for diagnostics and
closed loop feedback for drug delivery and
Functional Electrical Stimulation &
Electroceuticals.
Next Gen Sensors
43. Micromechanical Sensing & Detection
Nanotechnology Approaches to Sensing and Detection
Dr. James S. Murday Dr. Richard J. Colton, Naval Research Laboratory
http://www.frtr.gov/pdf/meetings/dec04/murday_12-04.pdf
C nanotube networks: Detection via field-
induced polarization of adsorbates on
SWNT surface
BioFETs: thin for efficient sensing (~2 nm).
source drain; specific attachment of DNA or protein
Biosensor Examples
44. Nano-materials for biosensor applications
Material Biosensor Application
Carbon nanotubes Single molecule detection
Titania nanotubes Hydrogen sensors; Enzyme immobilization
Nickel nanowhiskers Biomolecules impart "fingerprint" by changing the electrical signal of the
nanocontact
Metallic nanowires and
nanospheres
Nanoantennas, Molecular detection
Tin-Oxide platinum
electrodes sandwhich
Highly sensitive and stable nerve-gas sensor with potential ability to detect
a single molecule
Gold Nanocluster Chemical
Sensor
Molecular detection in solution
Antibody conjugated
Quantum dot
Molecular detection: Competition assays in solution; identification of tissue
biomarkers.
DNA-gold nanoparticles Highly sensitive and selective colormetric biosensor
Protein-encapsulated single-
walled carbon nanotubes
Near-infrared nanoscale sensor that detects target molecules
Polymers with optical
properties of hard crystalline
sensors
A silicon wafer is treated with an electrochemical etch to produce nano-
porous silicon chip - optical properties of a photonic crystal. Used as mold
for polymers - “replica” of the porous silicon chip.
45. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
INSTRUMENTATION/PACKAGING
• Spectrometry
• Light Scattering
• Microfluidics
• Nanosensors
• Biochips
• Thin film transistor arrays
• Scattering techniques
• Tissue culture techniques
MODELING
• Computational modeling:
- biomolecules
- crystallographic structures
- biokinetics and dosimetry
• Tissue-light interactions modeling
APPLICATIONS
• Disease Biomarkers
• DNA/Gene expression
• Chemical and Biotoxin Exposure
• Pathogen sensing
• Molecule detection
• Single molecule detection
Biosensor Development
Modified from:
http://www.ornl.gov/sci/biosensors/abstg_orgchart.pdf#search=
%22Advanced%20Biomedical%20Science%20and%20Technology
%20Group%22
46. Infectious Disease Applications
Deliver nano-enabled solutions for biosensors
•Detection of disease and infection
• Wireless Monitors for triage, and first response therapy
47. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Field-usable biosensor for identifying the infectious
diseases
• accurate, sensitive, and rapid (<15 min)
• desirable to have genetic identification of the virus strain, e.g., Influenza A
(H5N1/H7N9)
• Screening by identification of Influenza A is useful, but requires additional testing
to verify the strain
-reduces the utility of a test, particularly when rapid quarantine or culling of the
flock is required to prevent spread of the disease.
48. Wireless Monitoring
Ultralow power analogue transmission platform for remote patient
management, reprogrammable to operate in different frequency bands
and under standard wireless platforms for First Response and Triage
• Bandage-like patch with sensor to
monitor skin – moisture, pH,
temperature, EKG, etc
• Ultra-low power, wireless enabled
sensor platform using mixed signal,
analogue processing
• Vital sensing for military and triage
applications
49. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Implantable Sensors
CardioMEMS
50. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Example Implantable Glucose Sensor
Senseonics
53. First Neurally Controlled, Powered Prosthetic Limb Is 2,109 Steps Closer To
Realization
http://www.prnewswire.com/news-releases/first-neurally-controlled-powered-prosthetic-
limb-is-2109-steps-closer-to-realization-177780951.html
IRVINE, Calif., Nov. 7, 2012 /PRNewswire/ -- Freedom Innovations, LLC, a leading
developer of high technology prosthetic medical devices, announced today that research
participant Zac Vawter utilized the world's first neurally controlled, powered prosthetic
limb to climb 103 floors (2,109 steps) of Chicago's Willis Tower at the SkyRise Chicago
fundraiser. In this most grueling test of the technology to date, Vawter demonstrated that
this advanced research is quickly on its way to becoming available to lower-limb
amputees worldwide.
The computerized prosthetic limb Vawter used in the climb incorporates two significant
advancements in prosthetic technology. First, as the only system to feature fully-
powered knee and ankle prosthetic joints, the prosthetic limb is no longer passive.
Motors in the system replace muscle function lost from an amputation. This facilitates
power-driven ambulation that also allows an amputee to actively climb stairs and slopes.
Second, Vawter benefited from neural control of this powered system where his thoughts
helped to direct the software and action of the prosthetic limb via targeted muscle
reinnervation (TMR). Brain signals from nerves severed during amputation are rerouted
to intact muscles, allowing patients to control their robotic prosthetic devices by merely
thinking about the action that they want to perform
54. The final report of the Triennial Review of
the National Nanotechnology Initiative has
been released today.
https://download.nap.edu/catalog.php?
record_id=18271#toc
It was with great satisfaction working with
the co-chair, committee members and the
National Academies' staff on this important
document. Please read through the
findings and recommendations on a
program that has significant impact on
"basic and applied research and for
development of applications in
nanotechnology that will provide economic,
societal, and national security benefits to
the United States."
Nano-Enabled Medical Therapuetics
56. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Example of Emergent Technology
57. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Nanopores for drug
delivery
Nanoenabled Diagnostics andNanoenabled Diagnostics and
TherapiesTherapies
Nanoparticles to cross
The blood brain barrier:
Diagnostics, drug delivery
Gold shell nanoparticles for
Tumor ablation
Nanofiber Scaffolds for
Vascular prostheses &
Tissue engineering
Nanodiagnostics for point of care
Diagnosis: infectious disease,
biomarkers
Quantum Dots for
Molecular
Imaging
Nanoporous filters: Drug
delivery, Hemodialysis,
Plasmapheresis, Oxygenation –
Celgard has been available for
30 + years
58. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
carbon nanotube
http://smalley.rice.edu
domains in triblock copolymer
Helmus, ACS, 1982
59. The development of efficacious
therapeutic and diagnostic
procedures based on
nanotechnology will require the
early collaboration of clinicians
and an understanding of the
clinical environment
Nanomedicine
60. The Promise and the Challenge of Nano-enabled
technologies for Medical Applications
•Enhanced functionality and
biocompatibility
•Potential new paradigms required for
biocompatibility evaluations of nano-
structures and particles
61. Short
Long
Medical Applications
enabled by nanotechnologies
• Improved catheters, balloons, implants: Polymer Nano-Composites to
improve strength, stiffness and toughness
• Joint prostheses, stents: Metallic alloys - nano-grained, composites, and
coatings for strength, toughness, lubricity and wear resistance
• Biocompatible Surfaces and Drug Delivery Coatings: Nano-structured
surfaces
• Diagnostics and Imaging: Nanoparticles and carbon nanotubes
• Implantable biosensors and active muscle, nerve, neural electrodes: MEMs
and NEMs, tissue interfacing electrodes; small, low-power processors with
wireless communications
• Targeted drug delivery& cancer therapy: nanoparticles
Timetoc
62. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
On this T2*-weighted gradient-echo image obtained after the
administration of Feridex (ferumoxides), the lesion (arrow) has become
very hyperintense to the liver.
http://www.kjronline.org/abstract/files/v04n019.pdf
Jeong Min Lee, et al Korean J Radiol 4(1), March 2003
Superparamagnetic Nanoparticulate Iron Oxide for Liver Imaging
63.
64.
65. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Implantation of tissue
engineered construct.
Autologous cell
&/or stem
cells.
.
Scaffolds
Seeded scaffolds for
direct implantation or
growth of tissue in
bioreactor
Healed device
Translating Regenerative Medicine
Value
Product
Commercializati
on
Development &
Engineering
“Valley of Death”
Discovery &
Research
Technology Medicine
Idea Generation
Commercialization
mnhelmus@msn.com
66. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Small Molecules
Proteins/Growth Factors
Gene Transfection
Remodeled Organ
In Situ HealingIn Situ Healing
Injectables to recruit
bmc’s/tissue stem
cells to Regenerate in
situ.
70. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Artificial Organs May Finally Get a Blood Supply
Artificial tissue has always lacked a key ingredient: blood
vessels. A new 3-D printing technique seems poised to
change that.
•By Susan Young Rojahn on March 6, 2014
Why It Matters
Thousands of people die each year waiting for donor organs.
http://www.technologyreview.com/news/525161/artificial-organs-may-finally-get-a-
blood-supply/
71. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Living layers: Harvard researchers demonstrate their method for creating vascularized
tissue constructs by printing cell-laden inks in a layered zig-zag pattern. In what may be
a critical breakthrough for creating artificial organs, Harvard researchers say they have
created tissue interlaced with blood vessels.
Using a custom-built four-head 3-D printer and a “disappearing” ink, materials scientist
Jennifer Lewis and her team created a patch of tissue containing skin cells and biological
structural material interwoven with blood-vessel-like structures. Reported by the team in
Advanced Materials, the tissue is the first made through 3-D printing to include
potentially functional blood vessels embedded among multiple, patterned cell types.
72. Sustainability of Medical Therapeutics
Introduction to Biomaterials
Identification of Drivers for New Technology
- Leverage Potential Emergent/Disruptive Technology
- Sensors for Personalized Medicine
Biocompatibility as a design requirement of medical devices
- Coatings/Surface modification
- Next gen bioactive materials
- Nano-materials
Heart Valves
- Heart Valve Structural Performance
- Bioprosthetic Tissue and Tissue Engineering
Combination Devices
- Drug Eluting Stent Example
73. Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Drug Coated Stents
A Disruptive
Therapeutic Technology
74. A Solution:
Drug-Coated Stents
• Current Design Components andCurrent Design Components and
FunctionsFunctions
– Stent
• Provides a mechanical scaffold to maintain patency of vessel
– Drug
• Pharmacological or biological agent targeting cellular control of
restenosis
– Polymer Carrier
• Provides a means to control administration of drug (site, rate
and dose)
75. • Key features for theKey features for the
BiocompatibilityBiocompatibility
• of a drug eluting systemof a drug eluting system
• Conformal Coatings
• Mechanical Robustness
• Biostability
• Vascular Biocompatibility
• Suitable Carrier for the Drug and its
release
76. Combination drug-device productsCombination drug-device products
• Successful designs and applications are based on the integration ofSuccessful designs and applications are based on the integration of
many disciplines:many disciplines:
– Materials Sciences
– Engineering Fields (Mechanical, Chemical,
Bioengineering)
– Pharmaceutical Sciences
– Pre-clinical and Clinical evaluation of both drugs and
devices
– Pilot and Scale-up manufacturing for both drugs and
devices
– Regulatory appreciation for both devices and drugs,Regulatory appreciation for both devices and drugs,
with the ability towith the ability to
» recognize the novelrecognize the novel
» rely on the standardrely on the standard
» blend the two seamlesslyblend the two seamlessly
77. Chemistry, Manufacturing and Controls (CMC) Drug
Evaluation
• Drug SubstanceDrug Substance
– Structure, physicochemical properties,
manufacturing information
– Equivalent to NDA, IND, NCE
Drug ProductDrug Product
– Chemical characterization
– Manufacturing process
– Controls
• Impurities / degradants / residuals / kinetic drugImpurities / degradants / residuals / kinetic drug
releaserelease
• Stability
• Toxicity threshold
• Pharmacokinetics, Pharmacodynamics (MOA)
80. Technology
Local and Targeted
Diagnostics and Therapeutics
to allow “individualized
treatment for each patient”
Drug Delivery,
Tissue Engineering
& Cell Therapy
Biomarker &
Disease
Detection
Less Invasive
Procedures
Michael N. Helmus, Ph.D., Consultant
Medical Devices, Biomaterials
Drug Delivery, and Nanotechnology
(508) 767 0585
