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Technologies Driving Medtech Sustainability
Ideation Commercialization
Michael N. Helmus, PhD, Consultant
mnhelmus@msn.com
21st
Century
?
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
STRUCTURAL MATERIALSSTRUCTURAL MATERIALS
SURFACE MATERIALS:SURFACE M...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
STRUCTURAL MATERIALSSTRUCTURAL MATERIALS
SURFACE MATERIALS:SURFACE M...
Materials for Medical Devices
Biological Materials
Bioprosthetic, Autologous, Allografts, Xenografts, ECM, Polysaccharides...
Medical Coatings
•Biological Materials
•Carbonaceous
•Diamond
•Diamond-Like Carbon
•Graphite
•Nanocrystalline Diamond
•Pyr...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Endovascular
Peripheral Grafts
ePTFE Vascular Graft
Textile Vascular...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Percutaneously
placed endovascular
Stent
New Generation DevicesNew G...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Patient Receives 3D Printed Implant To
Replace 75 Percent Of Skull
…...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
3-D Printed
Metallic Devices
http://nsf.gov/discoveries/disc_summ.js...
MEDICAL DEVICE VALUE CHAIN
Bench/
Anim
al
Testing
D
istribution
Clinical
Application
Com
ponents/
D
evices
• Powders
• Dis...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Michael N. Helmus, PhD, Consultant
mnhelmus@msn.com
Technology Diffusion into the Innovation Ecosystem
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Technology Investment & Risk
Research
• Studies & Analysis
• Lab-Scale Demos
Cost
Risk
Manufacturing &
Commercialization
•...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Trends:Trends:
Younger patientsYounger patients
requiringrequiring
l...
Challenges of Developing Medical
Technology
Clinical Centers
Investors/ROI
Physician
Collaborators
IP Strategy
Competition...
Will bundled payments hurt healthcare innovation?
Written by Helen Adamopoulos | October 25, 2014
Bundled payment models —...
Identification of Drivers for New
Technology
• Cost Containment/Bundled Reimbursement
• New Diagnostics and Point of Care
...
• New Therapeutics
– Cancer
– Infectious Disease
– Immune Disease
– Minimally/Less Invasive Procedures
– Implants
– Tissue...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Leverage Potential Disruptive Technologies
Drug Delivery
Therapeutic...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Leverage ongoing Advances
•Bioabsorbable stents
•Robotically assiste...
•The bridge to commercialization
• Proof of principle in a clinically relevant setting
• Drivers for Development
• Cost Co...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Sustainablility of Medical Therapuetics
Sustainability of US healthc...
Personalized Medicine to Drive New Technology
Less Invasive Therapies
Custom Implants
Biosensors
Implantable biosensors, e...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Interventional Placements
of Implantable Devices and Treatments
e.g....
Personalized
Medicine
CellTherapies
Nano-Enabled
Electroceuticals
Disruptive Therapeutics
DigitalHealthcare
Time
Funtional...
The bridge to commercialization
–Proof of principle in a
clinically relevant
setting
PRODUCT LIFECYCLE FOR MEDICAL
DEVICES
Bench/
Anim
al
Testing
D
istribution
Clinical
Application
Com
ponents/
D
evices
Clin...
Medical Device Market
• Device Company Aggregate Top line 11%
annually
• from 1995-2005
• R&D Funding at 10.3 % of sales
•...
Medical Device Market – Examples of Cash Curves
510K A 510k B PMA
R&D Costs
$ 0.25M $ 2 M $80M
Regulatory Approval and Tim...
• PMA’s have high cost of failure
• Creating markets for niche products
• Leverage the physician and medical
center
• Cost...
Sustainability of Medical Therapeutics
Introduction to Biomaterials
Identification of Drivers for New Technology
- Leverag...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Traditional Definition:
Personalized Medicine
'The molecular methods...
Broader Definition of Personalized Medicine
Local and Targeted Diagnostics and
Therapeutics to allow “individualized
treat...
http://books.google.com/books?id=5Q-
O9vnNqPkC&pg=PR3&lpg=PP1&dq=creative+destruction+of+medicine
The Creative Destruction...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Recent Examples unique MedTech
Personalized Medicine
• Liquid Biopsi...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Setting Expectations
How to innovate while addressing concerns.
Sugg...
Personalized medicine. Personalized medicine includes the detection of disease
predisposition, screening and early disease...
This is Siri. We
have news for you.
You appear to be
dead!!!
Patients will be monitoring their own health with
Smart phone...
Mobile Digital Health
The smartphone has built-in sensors for monitoring heart rate, pulmonary function, blood sugar
level...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Next Gen Sensors will drive the thrust for
the evolution of personal...
Micromechanical Sensing & Detection
Nanotechnology Approaches to Sensing and Detection
Dr. James S. Murday Dr. Richard J. ...
Nano-materials for biosensor applications
Material Biosensor Application
Carbon nanotubes Single molecule detection
Titani...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
INSTRUMENTATION/PACKAGING
• Spectrometry
• Light Scattering
• Microf...
Infectious Disease Applications
Deliver nano-enabled solutions for biosensors
•Detection of disease and infection
• Wirele...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Field-usable biosensor for identifying the infectious
diseases
• acc...
Wireless Monitoring
Ultralow power analogue transmission platform for remote patient
management, reprogrammable to operate...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Implantable Sensors
CardioMEMS
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
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-rel...
The final report of the Triennial Review of
the National Nanotechnology Initiative has
been released today.
https://downlo...
NANOMATERIALS AND PROPERTIES
BIOMIMETICS
BIOACTIVE
Metal ceramic fiber
Ceramic metal filled
Polymer nanoparticulates
Polym...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Example of Emergent Technology
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Nanopores for drug
delivery
Nanoenabled Diagnostics andNanoenabled D...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
carbon nanotube
http://smalley.rice.edu
domains in triblock copolyme...
The development of efficacious
therapeutic and diagnostic
procedures based on
nanotechnology will require the
early collab...
The Promise and the Challenge of Nano-enabled
technologies for Medical Applications
•Enhanced functionality and
biocompati...
Short
Long
Medical Applications
enabled by nanotechnologies
• Improved catheters, balloons, implants: Polymer Nano-Composi...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
On this T2*-weighted gradient-echo image obtained after the
administ...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Implantation of tissue
engineered construct.
Autologous cell
&/or st...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Small Molecules
Proteins/Growth Factors
Gene Transfection
Remodeled ...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Medtech Strategist Nov. 2014
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Artificial Organs May Finally Get a Blood Supply
Artificial tissue h...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Living layers: Harvard researchers demonstrate their method for crea...
Sustainability of Medical Therapeutics
Introduction to Biomaterials
Identification of Drivers for New Technology
- Leverag...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
Drug Coated Stents
A Disruptive
Therapeutic Technology
A Solution:
Drug-Coated Stents
• Current Design Components andCurrent Design Components and
FunctionsFunctions
– Stent
• P...
• Key features for theKey features for the
BiocompatibilityBiocompatibility
• of a drug eluting systemof a drug eluting sy...
Combination drug-device productsCombination drug-device products
• Successful designs and applications are based on the in...
Chemistry, Manufacturing and Controls (CMC) Drug
Evaluation
• Drug SubstanceDrug Substance
– Structure, physicochemical pr...
Michael N. Helmus, Ph.D., Consultant
mnhelmus@msn.com
J. Biomed. Mater. Res.
Power of Nano Characterization
Technology
Local and Targeted
Diagnostics and Therapeutics
to allow “individualized
treatment for each patient”
Drug Deliv...
Technologies driving Medtech Sustainability
Technologies driving Medtech Sustainability
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Technologies driving Medtech Sustainability

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Technologies driving Medtech Sustainability

  1. 1. Technologies Driving Medtech Sustainability Ideation Commercialization Michael N. Helmus, PhD, Consultant mnhelmus@msn.com
  2. 2. 21st Century ?
  3. 3. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com STRUCTURAL MATERIALSSTRUCTURAL MATERIALS SURFACE MATERIALS:SURFACE MATERIALS: BIOLOGIC INTERACTIONS AND LUBRICITYBIOLOGIC INTERACTIONS AND LUBRICITY CONTROLLED DRUGCONTROLLED DRUG DELIVERY MATERIALSDELIVERY MATERIALS METALS ENGINEERING PLASTICS PLASTICS ELASTOMERS CERAMICS BIOACTIVE CERAMICS BIOACTIVE COATINGS BIOLOGICS BIODERIVED MACROMOLECULES HYDROPHILIC COATINGS HIGH STRENGTH MODERATE STRENGTH HIGH PERMEABILITY SURFACE COATINGS SPECTRUM OF MATERIALS AND PROPERTIES Bioactivity COMPOSITES AEROSPACEAEROSPACE DEFENSE SemiconductorDEFENSE Semiconductor ORTHOPEDICORTHOPEDIC DENTALDENTAL RESEARCHRESEARCH PHARMACEUTICAL AND BIOTECHPHARMACEUTICAL AND BIOTECH PlasticsPlastics & Textiles& Textiles IndustryIndustry
  4. 4. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com STRUCTURAL MATERIALSSTRUCTURAL MATERIALS SURFACE MATERIALS:SURFACE MATERIALS: BIOLOGIC INTERACTIONS AND LUBRICITYBIOLOGIC INTERACTIONS AND LUBRICITY CONTROLLED DRUGCONTROLLED DRUG DELIVERY MATERIALSDELIVERY MATERIALS METALS ENGINEERING PLASTICS PLASTICS ELASTOMERS Semi-Conductors CERAMICS BIOACTIVE CERAMICS BIOACTIVE COATINGS BIOLOGICS BIODERIVED MACROMOLECULES HYDROPHILIC COATINGS HIGH STRENGTH MODERATE STRENGTH HIGH PERMEABILITY SURFACE COATINGS SPECTRUM OF MATERIALS AND PROPERTIES Bioactivity COMPOSITES AEROSPACEAEROSPACE DEFENSEDEFENSE SemiconductorSemiconductor ORTHOPEDICORTHOPEDIC DENTALDENTAL RESEARCHRESEARCH PHARMACEUTICAL AND BIOTECHPHARMACEUTICAL AND BIOTECH PlasticsPlastics & Textiles& Textiles IndustryIndustry MEMSMEMS Nano-Nano- technology 3D Printingtechnology 3D Printing CVD-PVDCVD-PVD Self Assembled MoleculesSelf Assembled Molecules BiomimeticsBiomimetics Tissue EngineeringTissue Engineering
  5. 5. Materials for Medical Devices Biological Materials Bioprosthetic, Autologous, Allografts, Xenografts, ECM, Polysaccharides Carbonaceous Materials Pyrolytic, Graphitic, Graphene, Nanotube Ceramics Calcium Based, Glasses, Alumina, Zirconia Metals and Alloys Cobalt Base, Nitinol, Precious, Refractory Metals, Stainless Steels,Titanium Polymers/Plastics and Textiles Elastomers, Thermoplastics, Hydrogels, Engineering
  6. 6. Medical Coatings •Biological Materials •Carbonaceous •Diamond •Diamond-Like Carbon •Graphite •Nanocrystalline Diamond •Pyrolytic Carbon •Ceramics •Metals •Polymers, Synthetic •Semiconductors •Silicon Carbide
  7. 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. 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. 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. 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. 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
  12. 12. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com
  13. 13. Michael N. Helmus, PhD, Consultant mnhelmus@msn.com Technology Diffusion into the Innovation Ecosystem
  14. 14. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com
  15. 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. 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. 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. 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. 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. 20. • New Therapeutics – Cancer – Infectious Disease – Immune Disease – Minimally/Less Invasive Procedures – Implants – Tissue Engineering/Cell Therapy Drivers for New Technology cont.
  21. 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. 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. 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. 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. 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. 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
  27. 27. Personalized Medicine CellTherapies Nano-Enabled Electroceuticals Disruptive Therapeutics DigitalHealthcare Time Funtionality Biomaterials will drive new disruptive Medical Therapeutics as part of the Sustainability of Health Care Delivery
  28. 28. The bridge to commercialization –Proof of principle in a clinically relevant setting
  29. 29. PRODUCT LIFECYCLE FOR MEDICAL DEVICES Bench/ Anim al Testing D istribution Clinical Application Com ponents/ D evices Clinical Trials RawM aterials
  30. 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. 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. 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. 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. 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. 35. Broader Definition of Personalized Medicine Local and Targeted Diagnostics and Therapeutics to allow “individualized treatment for each patient”
  36. 36. 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
  37. 37. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Recent Examples unique MedTech Personalized 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
  38. 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. 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. 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. 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. 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. 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. 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. 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. 46. Infectious Disease Applications Deliver nano-enabled solutions for biosensors •Detection of disease and infection • Wireless Monitors for triage, and first response therapy
  47. 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. 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. 49. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Implantable Sensors CardioMEMS
  50. 50. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Example Implantable Glucose Sensor Senseonics
  51. 51. http://www.nature.com/news/Functional Electrical Stimulation-spark-interest-1.15494
  52. 52. Inspired by:
  53. 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. 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
  55. 55. NANOMATERIALS AND PROPERTIES BIOMIMETICS BIOACTIVE Metal ceramic fiber Ceramic metal filled Polymer nanoparticulates Polymer nanofibers Polymer-layered silicate nanocomposite(PLSN) Polyelectrolyte layered nanocomposites NANOPARTICLESNANOPARTICLES NANOCOMPOSITESNANOCOMPOSITES NANOSTRUCTUREDNANOSTRUCTURED BULK, COATINGS & SURFACESBULK, COATINGS & SURFACES NANOPOROUSNANOPOROUS DRUG DELIVERY DIAGNOSTICS Bottom up: CVD, PVD, Deposition processes by Laser, EBeam Self Assembly, Sintering Top down: Nanolithography, Nanomachining, Ablation, Dissolution BIOSENSORS MICROFLUIDI CS 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 PHOTONICS SEMICONDUCTO RS STRUCTURAL
  56. 56. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Example of Emergent Technology
  57. 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. 58. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com carbon nanotube http://smalley.rice.edu domains in triblock copolymer Helmus, ACS, 1982
  59. 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. 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. 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. 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. 63. 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
  64. 64. 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.
  65. 65. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com
  66. 66. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Medtech Strategist Nov. 2014
  67. 67. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com
  68. 68. 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/
  69. 69. 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.
  70. 70. 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
  71. 71. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com Drug Coated Stents A Disruptive Therapeutic Technology
  72. 72. 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)
  73. 73. • 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
  74. 74. 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
  75. 75. 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)
  76. 76. Michael N. Helmus, Ph.D., Consultant mnhelmus@msn.com
  77. 77. J. Biomed. Mater. Res. Power of Nano Characterization
  78. 78. 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

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