technologies driving medtech sustainability
TRANSCRIPT
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Technologies Driving Medtech Sustainability
Ideation CommercializationMichael N. Helmus, PhD, [email protected]
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21st
Century
?
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Michael N. Helmus, Ph.D., [email protected]
STRUCTURAL MATERIALSSTRUCTURAL MATERIALS
SURFACE MATERIALS:SURFACE MATERIALS:BIOLOGIC INTERACTIONS AND LUBRICITYBIOLOGIC INTERACTIONS AND LUBRICITY
CONTROLLED DRUGCONTROLLED DRUGDELIVERY MATERIALSDELIVERY MATERIALS
METALS ENGINEERINGPLASTICS
PLASTICS
ELASTOMERS
CERAMICS
BIOACTIVE CERAMICS
BIOACTIVECOATINGS
BIOLOGICS
BIODERIVEDMACROMOLECULESHYDROPHILIC
COATINGS
HIGH STRENGTH
MODERATESTRENGTH
HIGH PERMEABILITY
SURFACECOATINGS
SPECTRUM OF MATERIALS AND PROPERTIES
Bioactivity
COMPOSITES
AEROSPACEAEROSPACEDEFENSE SemiconductorDEFENSE Semiconductor
ORTHOPEDICORTHOPEDICDENTALDENTALRESEARCHRESEARCH PHARMACEUTICAL AND BIOTECHPHARMACEUTICAL AND BIOTECH
Plastics Plastics & Textiles& TextilesIndustryIndustry
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Michael N. Helmus, Ph.D., [email protected]
STRUCTURAL MATERIALSSTRUCTURAL MATERIALS
SURFACE MATERIALS:SURFACE MATERIALS:BIOLOGIC INTERACTIONS AND LUBRICITYBIOLOGIC INTERACTIONS AND LUBRICITY
CONTROLLED DRUGCONTROLLED DRUGDELIVERY MATERIALSDELIVERY MATERIALS
METALS ENGINEERINGPLASTICS
PLASTICS
ELASTOMERS
Semi-Conductors
CERAMICS
BIOACTIVE CERAMICS
BIOACTIVECOATINGS
BIOLOGICS
BIODERIVEDMACROMOLECULESHYDROPHILIC
COATINGS
HIGH STRENGTH
MODERATESTRENGTH
HIGH PERMEABILITY
SURFACECOATINGS
SPECTRUM OF MATERIALS AND PROPERTIES
Bioactivity
COMPOSITES
AEROSPACEAEROSPACEDEFENSEDEFENSESemiconductorSemiconductor
ORTHOPEDICORTHOPEDICDENTALDENTALRESEARCHRESEARCH PHARMACEUTICAL AND BIOTECHPHARMACEUTICAL AND BIOTECH
Plastics Plastics & Textiles& TextilesIndustryIndustry
MEMSMEMS Nano-Nano- technology 3D Printingtechnology 3D Printing CVD-PVDCVD-PVD
Self Assembled MoleculesSelf Assembled MoleculesBiomimeticsBiomimetics
Tissue EngineeringTissue Engineering
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Materials for Medical Devices
Biological Materials Bioprosthetic, Autologous, Allografts, Xenografts, ECM, Polysaccharides
Carbonaceous MaterialsPyrolytic, Graphitic, Graphene, Nanotube
Ceramics
Calcium Based, Glasses, Alumina, Zirconia
Metals and Alloys Cobalt Base, Nitinol, Precious, Refractory Metals, Stainless Steels,Titanium
Polymers/Plastics and TextilesElastomers, Thermoplastics, Hydrogels, Engineering
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Medical Coatings
•Biological Materials •Carbonaceous
•Diamond •Diamond-Like Carbon •Graphite •Nanocrystalline Diamond •Pyrolytic Carbon
•Ceramics •Metals •Polymers, Synthetic •Semiconductors
•Silicon Carbide
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Michael N. Helmus, Ph.D., [email protected]
Endovascular
Peripheral Grafts
ePTFE Vascular Graft
Textile Vascular Grafts
Collagen Coated PET
NiTiNOL stent
OEM - Sewing cuff Heart ValvesAnnuloplasty rings
Scaffolds for Tissue engineering
Mesh
for Hernia Repair
Traditional Biomaterials in Devices
CoilsBrain Aneurysms
Prosthetic joints
Bone repair - bone plates
Vertebroplasty -Bone cement filling of Compressed vertebrae
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Michael N. Helmus, Ph.D., [email protected]
Percutaneously placed endovascular
graft
Stent
New Generation DevicesNew Generation Devices
GDC® CoilsBrain Aneurysms Drug
elut ing &
Bioaborbable
stent
Injectable Polymer: endoscopic therapy for GERD
Uter ine Sling -Repliform ® TissueRegenerat ion Mat r ix , human derm isarchit ect ure w it h 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 engineeringBioactive andBioresorbable Fabrics
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Michael N. Helmus, Ph.D., [email protected]
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/
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Michael N. Helmus, Ph.D., [email protected]
3-D Printed Metallic Devices
http://nsf.gov/discoveries/disc_summ.jsp?cntn_id=129867
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MEDICAL DEVICE VALUE CHAIN
Bench
/
Animal
Testin
gDist
ributio
n
Clinica
l
Applicati
on
Compon
ents/
Device
s
• Powders
• Dispersions
• Coatings
• Composites
• Biomaterials
• Proteomics
• Genomics
Formulation Fabrication Integration
Synthesis ModificationSeparation, Purification
Clinica
l
TrialsRaw
Mate
rials
Technology Medicine
Develop IP Strategy: Composition of Matter ApplicationsFile IP
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Michael N. Helmus, Ph.D., [email protected]
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Michael N. Helmus, Ph.D., [email protected]
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Technology Investment & Risk
Research• Studies & Analysis
• Lab-Scale Demos
CostRiskManufacturing &
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
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Michael N. Helmus, Ph.D., [email protected]
Trends:Trends:
Younger patients Younger patients requiringrequiring
longer term longer term performanceperformance
requirements!requirements!
The Wall Street JournalThe Wall Street JournalFri. Aug 22, 2003Fri. Aug 22, 2003
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Challenges of Developing MedicalTechnology
Clinical Centers
Investors/ROI
Physician Collaborators IP Strategy
Competition
Resource LimitsM&A and
Downsizing
Regulatory Strategy
Commercial Lifetime
Technical Challenge - Design Intent
Bundled Insurance Reimbursement
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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.
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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
PersonalizedMedicine
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• New Therapeutics– Cancer– Infectious Disease– Immune Disease– Minimally/Less Invasive Procedures– Implants– Tissue Engineering/Cell Therapy
Drivers for New Technology cont.
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Michael N. Helmus, Ph.D., [email protected]
Leverage Potential Disruptive TechnologiesDrug Delivery Therapeutic PolymersBiodegradables 3D PrintingTissue EngineeringStem CellsSmart Materials Imaging, e.g. Molecular ImagingGenomicsProteomicsGlycomicsComputationNanoStructuresMEMS, eg CardioMemsTelemetered/sensored implants
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Michael N. Helmus, Ph.D., [email protected]
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
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•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
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Michael N. Helmus, Ph.D., [email protected]
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
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Personalized Medicine to Drive New TechnologyLess 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”
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Michael N. Helmus, Ph.D., [email protected]
Interventional Placementsof Implantable Devices and Treatments e.g. CABG, Heart Valves, JointsTissue Engineered Constructs, Chordae Tendon Repair, BiodegradableInjectables for Heart FailureImplantable Sensors
Fun
ctio
nali
ty
Time
Surgical Surgical
Interventional/Interventional/MIS -MIS -Stents , HVsStents , HVs
Implantable Implantable SensorsSensors
Disruptive Technology: Surgical Procedures
GenomicsGenomicsIdentifying Effective Identifying Effective TherapiesTherapies
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PersonalizedMedicine
Cel
l The
rapi
es
Nano-Enabled
Electroceuticals
Disruptive Therapeutics
Dig
ital
Hea
lthca
re
Time
Fun
tiona
lity
Biomaterials will drive new disruptive Medical Therapeutics as part of the Sustainability of Health Care Delivery
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The bridge to commercialization
–Proof of principle in a clinically relevant
setting
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PRODUCT LIFECYCLE FOR MEDICAL DEVICES
Bench
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Animal
Testin
gDist
ributio
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Clinica
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Applicati
on
Compon
ents/
Device
sClin
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TrialsRaw
Mate
rials
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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 supplementsP. 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
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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 Market15 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
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• 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
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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 DevicesDrug Eluting Stent
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Michael N. Helmus, Ph.D., [email protected]
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/sciencepolicy/personalmed-101_overview.php
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Broader Definition of Personalized Medicine
Local and Targeted Diagnostics and
Therapeutics to allow “individualized
treatment for each patient”
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http://books.google.com/books?id=5Q-O9vnNqPkC&pg=PR3&lpg=PP1&dq=creative+destruction+of+medicine
The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare By Eric J. Topol
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Michael N. Helmus, Ph.D., [email protected]
Recent Examples unique MedTechPersonalized Medicine
• Liquid Biopsies - http://www.viatarctcsolutions.com/products.html
• Therapeutic Oncopheresis - http://www.viatarctcsolutions.com/products.html
• FETS Biosensors - http://pubs.acs.org/doi/full/10.1021/acsomega.6b00014
• Smart Sutures (Sensors) - http://www.gizmag.com/smart-sutures-tufts/44402/http://www.nature.com/news/electronic-skin-equipped-with-memory-1.14952
• Targeted and Therapeutic Nanoparticles - http://www.ironfocusmedical.com
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Michael N. Helmus, Ph.D., [email protected]
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.”
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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
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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.
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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
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Michael N. Helmus, Ph.D., [email protected]
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
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Micromechanical Sensing & Detection
Nanotechnology Approaches to Sensing and DetectionDr. James S. Murday Dr. Richard J. Colton, Naval Research Laboratoryhttp://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
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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.
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Michael N. Helmus, Ph.D., [email protected]
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
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Infectious Disease Applications
Deliver nano-enabled solutions for biosensors
•Detection of disease and infection
• Wireless Monitors for triage, and first response therapy
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Michael N. Helmus, Ph.D., [email protected]
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.
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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
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http://www.nature.com/news/Functional Electrical Stimulation-spark-interest-1.15494
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Inspired by:
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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
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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
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NANOMATERIALS AND PROPERTIESBIOMIMETICS
BIOACTIVE
Metal ceramic fiber
Ceramic metal filled
Polymer nanoparticulates
Polymer nanofibers
Polymer-layered silicate
nanocomposite(PLSN)
Polyelectrolyte layered
nanocomposites
NANOPARTICLESNANOPARTICLES NANOCOMPOSITESNANOCOMPOSITES
NANOSTRUCTURED NANOSTRUCTURED BULK, COATINGS & SURFACESBULK, COATINGS & SURFACES
NANOPOROUS NANOPOROUS
DR
UG
D
EL
IVE
RY
DIA
GN
OS
TIC
S
Bottom up: CVD, PVD,
Deposition processes by Laser, EBeam
Self Assembly, Sintering
Top down: Nanolithography,
Nanomachining, Ablation, Dissolution
BIOSENSORSMICROFLUIDICS
Microphase separated polymers
Nanograined ceramics & metals
Self-assembled monolayers
Surface nano-clusters
SWNT Fibers
Polymeric Fibers and yarns
Nanowires
Nanotubes – Carbon, BN, Metallic Metal
Nanoribbons
Quantum Dots
Dendrimers
Gold and metallic nanoshells
Buckminister Fullerenes
Paramagnetic nanoparticles
PH
OT
ON
ICS
SE
MIC
ON
DU
CT
OR
SS
TR
UC
TU
RA
L
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Michael N. Helmus, Ph.D., [email protected]
Nanopores for drug
delivery
Nanoenabled Diagnostics and Nanoenabled Diagnostics and TherapiesTherapies
Nanoparticles to crossThe blood brain barrier:Diagnostics, drug delivery
Gold shel l nanopart icles for Tumor ablation
Nanofiber Scaffolds for Vascular prostheses &Tissue engineering
Nanodiagnostics for point of careDiagnosis: infectious disease, biomarkers
Quantum Dots for MolecularImaging
Nanoporous f i l ters: Drug delivery, Hemodialysis, Plasmapheresis, Oxygenation – Celgard has been avai lable for 30 + years
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Michael N. Helmus, Ph.D., [email protected]
carbon nanotube http://smalley.rice.edu
domains in triblock copolymerHelmus, ACS, 1982
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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
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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
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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
Tim
e to
co
mm
ercialize
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Michael N. Helmus, Ph.D., [email protected]
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.pdfJeong Min Lee, et al Korean J Radiol 4(1), March 2003
Superparamagnetic Nanoparticulate Iron Oxide for Liver Imaging
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Michael N. Helmus, Ph.D., [email protected]
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
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Michael N. Helmus, Ph.D., [email protected]
Small MoleculesProteins/Growth FactorsGene Transfection
Remodeled Organ
In Situ HealingIn Situ Healing
Injectables to recruit bmc’s/tissue stem cells to Regenerate in situ.
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Michael N. Helmus, Ph.D., [email protected]
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Michael N. Helmus, Ph.D., [email protected]
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Michael N. Helmus, Ph.D., [email protected]
Artificial Organs May Finally Get a Blood SupplyArtificial 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 MattersThousands of people die each year waiting for donor organs.
http://www.technologyreview.com/news/525161/artificial-organs-may-finally-get-a-blood-supply/
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Michael N. Helmus, Ph.D., [email protected]
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.
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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
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A Solution: Drug-Coated Stents
• Current Design Components and Current 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)
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• Key features for the Key features for the Biocompatibility Biocompatibility
• of a drug eluting system of a drug eluting system
• Conformal Coatings• Mechanical Robustness• Biostability• Vascular Biocompatibility• Suitable Carrier for the Drug and its
release
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Combination drug-device productsCombination drug-device products
• Successful designs and applications are based on the integration of Successful 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 to with the ability to » recognize the novel recognize the novel » rely on the standardrely on the standard» blend the two seamlesslyblend the two seamlessly
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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 drug Impurities / degradants / residuals / kinetic drug
releaserelease• Stability• Toxicity threshold• Pharmacokinetics, Pharmacodynamics (MOA)
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Michael N. Helmus, Ph.D., [email protected]
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J. Biomed. Mater. Res.
Power of Nano Characterization
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Personalized Medicine to Drive New Technology
Local and Targeted Diagnostics and Therapeutics to allow “individualized treatment for each patient”
Drug Delivery,Tissue Engineering& Cell Therapy
Biomarker &Disease Detection
Less InvasiveProcedures
Michael N. Helmus, Ph.D., ConsultantMedical Devices, Biomaterials Drug Delivery, and Nanotechnology(508) 767 0585