technologies driving medtech sustainability

Technologies Driving Medtech Sustainability

Ideation CommercializationMichael N. Helmus, PhD, [email protected]

21st

Century

?

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


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

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

http://products.asminternational.org/meddev/twoframes.aspx?main=__HOMEPAGE__&side=Tree.aspx

Medical Coatings

•Biological Materials •Carbonaceous

•Diamond •Diamond-Like Carbon •Graphite •Nanocrystalline Diamond •Pyrolytic Carbon

•Ceramics •Metals •Polymers, Synthetic •Semiconductors

•Silicon Carbide


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


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


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/

http://www.oxfordpm.com/news/article/2013-02-18_osteofab_patient_specific_cranial_device_receives_510k_approval_-_osteofab_implants_ready_for_us_market_and_beyond

http://singularityhub.com/wp-content/uploads/2013/03/OsteoFab-banner.jpg


3-D Printed Metallic Devices

http://nsf.gov/discoveries/disc_summ.jsp?cntn_id=129867

MEDICAL DEVICE VALUE CHAIN

Bench

/

Animal

Testin

gDist

ributio

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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

Michael N. Helmus, PhD, [email protected]

Technology Diffusion into the Innovation Ecosystem

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


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

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

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.

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

• New Therapeutics– Cancer– Infectious Disease– Immune Disease– Minimally/Less Invasive Procedures– Implants– Tissue Engineering/Cell Therapy

Drivers for New Technology cont.


Leverage Potential Disruptive TechnologiesDrug Delivery Therapeutic PolymersBiodegradables 3D PrintingTissue EngineeringStem CellsSmart Materials Imaging, e.g. Molecular ImagingGenomicsProteomicsGlycomicsComputationNanoStructuresMEMS, eg CardioMemsTelemetered/sensored implants


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

•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


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

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”


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

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

The bridge to commercialization

–Proof of principle in a clinically relevant

setting

PRODUCT LIFECYCLE FOR MEDICAL DEVICES

Bench

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Applicati

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Compon

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Device

sClin

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TrialsRaw

Mate

rials

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

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

• 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

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


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

Broader Definition of Personalized Medicine

Local and Targeted Diagnostics and

Therapeutics to allow “individualized

treatment for each patient”

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


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


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.”

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

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.

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


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

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

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.


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

Infectious Disease Applications

Deliver nano-enabled solutions for biosensors

•Detection of disease and infection

• Wireless Monitors for triage, and first response therapy


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.

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


Implantable SensorsCardioMEMS


Example Implantable Glucose Sensor

Senseonics

http://www.nature.com/news/Functional Electrical Stimulation-spark-interest-1.15494

Inspired by:

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

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

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


Example of Emergent Technology


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


carbon nanotube http://smalley.rice.edu

domains in triblock copolymerHelmus, ACS, 1982

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

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

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


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


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

[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.


Medtech Strategist Nov. 2014


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/


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.

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


Drug Coated Stents

A DisruptiveTherapeutic Technology

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)

• 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

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

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)

J. Biomed. Mater. Res.

Power of Nano Characterization

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

technologies driving medtech sustainability

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