IIT Bombay, B. I.I.T. Idea to...

© Prof. B. Ravi, I.I.T. Bombay

Prof. B. Ravi, OrthoCAD LabMechanical Engineering, IIT Bombay

Idea to Reality:Translational R&D Opportunities in

Medical Device Innovation

IIT Bombay, 27 March 2014


Top Imports Value

Crude Petroleum $ 172 b

Precious Metals & Stones $ 91 b

Capital Goods $ 72 b

Chemicals, Fertilizers $ 35 b

Electronics, IT, Medical $ 25 b

Top Exports Value

Metals, Minerals, Oils $ 57 b

Gems & Jewelry $ 47 b

Engineering Goods $ 44 b

Cotton, Textile, Leather $ 31 b

Chemicals, Pharma, Food $ 29 b

GDP = US$ 1842 billionWorking Population (15‐64 y) = 770 million

National Manufacturing Policy:By 2022, increase share to:

25% of GDP 100 million additional jobs

Sector Employed GVA

Agriculture 53 19

Services 24 53

Industry 23 28

[Source: Planning Commission, March 2014]

Mfg. 10 15

India – Economic Perspective

US$ 1 b = Rs. 6000 crore


Indian Healthcare: US$ 20 bDevices & Equipment: US$ 4 bImports (75%): US$ 3 b

India: Strong in Pharma (~ 10,000 firms)USA: 6,000 medical device firmsTaiwan: Devices worth US$ 1.5 b mfd.

DIAGNOSTIC THERAPEUTIC

Medical Device Industry


Inspiration Initial MDI Projects Relevant Technologies Training: Flipped Class Recent MDI Projects Opportunities

Overview

© Prof. B. Ravi, I.I.T. BombayInspiration – India’s Medical Heritage

Plastic surgery for repair of nose using a pedicle flap from the cheek as described by Susruta(later in 18th century practitioners used the flap from forehead)

Charaka’s House for treatmentRooms for patients, physicians, attendants, medications, procedures, musicians, story tellers and friends. It was located in serene surroundings. Based on Charaka’s description and design of houses in Kusana period.

Source: Towards Ayurvedic Biology, Dr. MS Valiathan


Sree Chitra Tirunal Institute for Medical Sciences and TechnologyThiruvananthapuram

Inspiration – SCTIMST, Trivandrum

© Prof. B. Ravi, I.I.T. BombayInspiration – Sushrut Surgicals

Sushrut Surgicals Pvt. Ltd. Mumbai (Office) / Pune (R&D) / Ratnagiri (Works)

Orthopedic trauma implants & instruments

© Prof. B. Ravi, I.I.T. BombayInspiration – Stryker, USA

Sales in 2013:US$ 9 billion


Stanford Biodesign ProgrammeIndia: IITD and AIIMS, New Delhi

Inspiration – Stanford Biodesign Programme


Medical Device Innovation CentreNational Cheng Kung University, Tainan, Taiwan

Inspiration – Taiwan Medical Device Centre

Bio‐Mechanics Lab Dental Surgery Training System Dynamic Testing


Technology Business ParkTainan, Taiwan

Inspiration – Taiwan Medical Device Industry

© Prof. B. Ravi, I.I.T. BombayMedical Devices for India

Billion Dollar Question: Can India innovate its own medical devices?


Maxillofacial surgery planning model

Auricular prosthesis

Custom pelvic implant

Early Projects: 2003‐2006


Patient with severe midface undergrowth

Distraction Osteogenesis

Courtesy: Dr. Shama Rao, NM Institute of Maxillofacial Surgery, Mangalore

© Prof. B. Ravi, I.I.T. BombayModel Fabrication and Protocol Planning

Fabrication on Stratasys FDM RP machine at IIT Distraction osteogenesis plan

© Prof. B. Ravi, I.I.T. BombayOutcome of Surgical Intervention

Pre‐Operative

Post‐Operative


An 18 yr male patient with microtia of the right ear

Requires an adhesive retained auricular prosthesis with maximum accuracy, details, aesthetics, and fit.

Customized Ear Prosthesis (Cosmetic)

Courtesy: Dr. Chandana Nair, Dr. S. Rajesh, Govt. Dental College & Hospital, Mumbai

© Prof. B. Ravi, I.I.T. BombayRapid Fabrication of Prosthesis Model

CAD Model RP Model Plaster Mold Wax Piece

© Prof. B. Ravi, I.I.T. BombayRapid Fabrication of Final Model

Silicone Rubber Colour Match Mold Stripping Finishing

© Prof. B. Ravi, I.I.T. BombayCustomized Hip Prosthesis

Resection of malignant pelvic bone tumour to be planned and practiced in advance, communicated to prosthesis manufacturer, and mutual fit checked on physical model, using CAD and RP technologies.

Hip prosthesis

Saddle

Tumour

Courtesy: Dr. Manish Agarwal, Tata Memorial Hospital, Mumbai

© Prof. B. Ravi, I.I.T. BombayTumor Demarcation in CT Scan

Bone and tumour demarcation in 3D Doctor

Bonedemarcation

Tumourdemarcation

© Prof. B. Ravi, I.I.T. BombayMedical Reconstruction

Tumour

© Prof. B. Ravi, I.I.T. BombayResection Planning

Tumour boundary

Resection line

© Prof. B. Ravi, I.I.T. BombayProsthesis Implantation

Entire project was completed in 3 weeks (2 weeks for manufacture) Gap between prosthesis and remaining pelvic bone < 2 mm, as planned Today: The patient is walking and even climbing stairs (aided)


Limb saving surgery in a child with bone cancer

using imported prosthesis,by Dr. Manish Agarwal in

TMH Mumbai, March 2004

Tumour Knee Prosthesis Surgery

Tumour Knee Prosthesis

Bone tumor in childrenand Limb‐saving surgery

CAD model

RP model

Final Prosthesis

Knee mega endo‐prosthesis(Modular rotating‐hinge design suitable for Indian patients)

Ti‐6Al‐4VStem

HA Collar

Co‐Cr‐MoCondyle

UHMWPETibial Poly

TUMOUR

OrthoCAD Project: Low‐cost High‐Quality TKP

Femoral Measurement and Cutting JigError‐prone protocol replaced with guided device

Tibial Cutting Jig ensures cutting plane is perpendicular to bone canal

PATENT

Surgical Instruments

Stress AnalysisFEM MeshFinal Prosthesis and Surgical Instruments

R&D, Materials and Manufacturing Partner:NFTDC, Hyderabad

3D Model Bone StockDeformitiesLandmarks

Selection Alignment

CT Images

Surgery Planning Software

Voxel model

RP Model Ceramic ShellCasting Simulation

Stress Analysis

CondyleModel

CNC Machining

CNC Tool Path

Cast CondyleFinish Condyle

Surgery Planning

Automated Inspection

3D CADModel

FEM Mesh

Casting Simulation

FEM Mesh

FEM Analysis

Leveraging 3D Technologies

3D CAD Solid Modelling

Solid models can also be generated from a cloud of points obtained from 3D laser scanning

3D Haptic CAD Modelling

Layer‐by‐layer additive manufacture with polymersfor quick validation of design: form, fit and function

Rapid Prototyping (Additive Manufacture)

Rapid Prototyping System in 1996: Expensive!

Rapid Prototyping System in 2014: Low cost!

Rapid Prototype to Metal Part

Wax RP pattern

Shell mold for investment casting

Steel Ganesha

E‐Foundry Tabletop Metal Casting

Water tank

Complex mold

Precision Manufacturing

Biocompatibility Surgical Suitability

Functional Suitability

Structural Integrity

Morphological Suitability

Underhang Underhang

Implantability & Revisability

KinematicSuitability

Static Safety

Dynamic Safety

Longevity(Life)

Integrated Testing Protocol

Hemant BhansaliLaparoscopic Surgeon

Nanavati Hospital

B. RaviEngg. ProfessorOrthoCAD LabIIT Bombay

Guruprasad RaoRapid

PrototypingImaginarium

SC KalyanpurPrecision

ManufacturerSridevi Tool Engg.

Chirag TannaPatentAttorneyInk Idee

Arun SapreMember Secretary

Rajiv GandhiS&T Commission

IDEA DESIGN PROTOTYPE DEVICE PATENT SCALE‐UP

Novel Suture Device

Dr.HB RGSTCMAHARASHTRA

Recent Project: From Idea to Reality

Jointly presented at WIROC 2014 (Western India Regional Orthopedic Conference), Mumbai

Advance needle along curvature Suture location, span, tissue bite Needle entrance, advancing Knot ‐ secure, stable, strong Minimize tissue trauma

“Most surgeons do not knowwhat is ideal suturing.”

‐ Dr. S. Saki, ICS Journal, 1997Japan Metropolitan Hospital

IDEA DESIGN PROTO DEVICE PATENT SCALE‐UP Dr.HB

Suturing


Translation Roll (Gross)

Roll

Pitch

xy

zFulcrumCoordinateFrame

Translation Roll

Pitch

xy

zFulcrumCoordinateFrame

Yaw

Suturing

Major limitations(based on instrument)

Special needles Needle slippage Skill‐intensive High cost

[SuturTek Endo 360]


Suture Instruments

Ideas!


Novel Suturing Device?

IDEA DESIGN PROTO DEVICE PATENT SCALE‐UP

Needle

Needle holder(grip, turn, release, return)

Suture

Suture Device Concept


Suture Device Concept

Suture Mechanism(Stainless Steel)

Front Assembly (Stainless Steel)

Back Housing: (HDPE / Aluminum)

Trigger(Stainless Steel)


CAD Model Mock‐up

Suture Device Design

Material = PlasticParts > 40Time < 2 daysCost < Rs. 40,000


Suture Device Prototype (Plastic)

Suture device: many small components Mating constraints, tight tolerances, finish Short lead time (only days) available Process and machine selection critical


Manufacturing Challenges


Laser Welding

CNC MillingWirecut EDM

Suture Device Components

Suture Device


Suture Device Prototype (Metal)

1995, 1996, 2009US Patent (SUTURTEK)

PRIOR ART

2009, 2011US Patent

(ENDOEVOLTION)

INVENTION

2013INDIAN Patent

(Dr. Hemant Bansali & IIT‐B)


Intellectual Property Rights


Suture Device Patent

Surgeons(Hospitals)

Engineers(Institutes)

Entrepreneurs(Companies)

Ravine

RGSTCMAHARASHTRA

Deep Canyon

Patients(Society)

Valley


Translational R&D – Need

Biomedical Engineering: Priority Area Start supporting indigenous innovations Bring multi‐disciplinary researchers closer Indigenous capability and industry in the long run

RGSTCMAHARASHTRAIDEA DESIGN PROTO DEVICE PATENT SCALE‐UP

Translational R&D

Rajiv Gandhi Science & Technology Commission, Maharashtra

Anil Kakodkar T. Ramasami M.S.Swaminathan Ram Takwale Pramod Kale

Focus on applications All disciplines of Science and Technology Interface between Research and end‐users Supported over 50 projects at various institutions Priority for multi‐disciplinary and networked projects.

REQUIREMENT ANALYSIS

DEVICE DESIGN & PROTOTYPING

MATERIALS & MANUFACTURING

CHARACTERIZATION & TESTING

CLINICAL ENGG, FIELD TRIALS

IPR, TRAINING, TECH TRANSFER

MEDICALINSTITUTES

IIT BombayVNIT NagpurCOE Pune

RESEARCHINSTITUTES

SCTIMST,CLINICIANS

DEVICEPRODUCERS

REGULATORYBODIES

BETiC

Integrated network facility for surgeons to bring their ideas to reality

RGSTCMAHARASHTRAIDEA DESIGN PROTO DEVICE PATENT SCALE‐UP

Biomedical Engg. & Technology Incubation Centre

Google OrthoCAD→ BETiC

Clinical Champion

Significant Local Need

R&D Capability

Innovation Potential

Project Selection Criteria


I. Define1. Identify a suitable problem

2. Form the project team

3. List device requirements

II. Develop4. Evolve the design concept

5. Select component materials

6. Decide manufacturing route

III. Deliver 7. Prototype and test

8. Optimize the design

9. Prepare a business plan

PRINCIPLES

TOOLS, SKILLS

EXAM

PLES

COURS

E PR

OJECT

Medical Device Innovation Training

© Prof. B. Ravi, I.I.T. BombayMedical Device Innovation Training

‘Flipped Classroom’ pedagogy in ME 676 Collaborative Engineering course

© Prof. B. Ravi, I.I.T. BombayMedical Device Innovation Training

Student project evaluations by expert surgeons and industry experts

Dear Prof. Ravi,

My heart filled congratulations for a most meticulous, perfect time bound & neat event. It is a most PROUD event of my life.

I feel our BETiC should be like a Strait connecting the Mediterranean Sea (DOCTORS) with Atlantic Ocean (ENGINEERS).

I hope & dream that BETiC one day should be a total Governing & Certifying Body for all medical devices in the market (like or better than the US FDA).

Prof Dr. Suresh DeshpandeHead, Department of Minimal Access SurgeryA S Hospital, KolhapurPresident IAGES 2010‐12 and Trustee, IAGESwww.swaruprobotics.comwww.lapindianrobot.com

© Prof. B. Ravi, I.I.T. BombayMedical Devices Patented

Shah, Ghyar, Ravi and Shetty, “Modular knee joint implant for anatomical variation” Indian Patent 2575/MUM/2012

Karade and Ravi, “Unerring alignment and resection guide assembly” Indian Patent 85/MUM/2012

Bhansali, Ghyar and Ravi “Auto‐suturing device for laparoscopic surgery”

Indian Patent 1880/MUM/2013

Class 1,2 Class 3Class 2

Clinical Immersion

Med. DeviceDesign

Prototype, Evaluation

DeviceManufacture

Bio‐mechTesting

Clinical Trials

IPR, TechTransfer

Implants, Instruments, Diagnostic and Rehabilitation

Devices

Summary: Medical Device Innovation Lifecycle

Medical Device Innovation: Multi‐disciplinary and multi‐talented challenge Clinical pull found to be better than technology push Critical: Surgeon‐engineer interaction, correct problem definition

OrthoCAD Experience: CAD and 3D Printing help reduce overall time and costMDI can be easily learnt by self‐driven collaborative groups Useful: ‘Flipped classroom’ pedagogy; clear focus on project

BETiC Opportunity: Medical domain increasingly driven by engineering & technology Translational R&D to develop affordable devices for local populationWelcome: Medical device innovators and entrepreneurs

Conclusion

Learn the game from BETiC online resources

Meet a surgeon, observe, ask questions

What You Can Do

Come up with a novel problem & solution

Fabricate prototype, get surgeon feedback

Further steps: manufacture, testing, patenting

↑ BETiC Can Help

Thank You!

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