1. By
Dr Mehul Pancholi
Research Assistant
The City University London
Other Partners:
Neurosurgery department, The Royal London Hospital, NHS.
Aesculap Inc., B.Braun company, Germany.
Emerald Technology Transfer, London, UK.

2. Medical
Device
Design
Time &
constrains
Funding
Academics
Other
stack
Holders
Clinicians
Quality
and
Regulation

3. • Mission, SWOT, Acceptance Criterion
Strategic Target
• Observation, Literature, Stake holder
Recognition of Problem and Observation
• Diseases, Treatments, Stakeholder
Need Screening
• With team members and stakeholders
Idea and Brainstorming
• IP, Regulatory, Business, Prototyping
Concept Screening and Selection
• IP, R&D, Regulatory, Quality etc strategy
Development Strategy
• Business Model, Funding, Licensing
Integrating Design, Development and Business

4. Review
Medical
Device
User Needs
Design
Input
Design
Process
Design
Output
Validation
Verification

5. Design and development of intelligent artificial spinal
disk prosthesis to measure the comprehensive in vivo
loading on the lumbar spinal disk
To measure the in vivo loading on the lumbar spinal disk

6.  Spine is the most complicated Neuro-Musculo-Skeletal joint (or series
of joints) of the body
 Related diseases: Disk degenerative diseases
 Mechanical loading and Disk Degenerative Diseases have positive
strong relationship
 Surgical treatment options: Motion preservation (TDR) and fusion
 Economical Back Pain Impact: In the UK, the National Health Service
(NHS) spends £512 million on hospital costs, £141 million on GP
consultation and £150.6 million on physiotherapy treatment. The total
spending is more than £1 billion per year

7.  Sensors on spinal
instruments
 Sensors on vertebrae or
disk
 Sensors on spinal disk
prosthesis
Sensors
Loading
Spinal disk
prosthesis
Vertebra

8.  Comparative stress analysis test: Axial compression load rating test
(First using FEA software and then actual) using MES – Limit load
analysis
 Liner static stress analysis for axial fatigue test using MES – Plastic
collapse analysis -3KN for 5 Million cycles – Lower max stress value
longest fatigue life
 Linear static stress analysis for torsion fatigue test – surface forces
totalling 200N in bending direction – linear elastic FEA – Lower the
alternating stress range longer fatigue life

9. Disc Wear
Inlay
Deformation
Plate/Inlay
Fracture
Implant-Bone
Interface
unphysiologic
al Kinematics

10.  4h: -300N, static conditioning
 16h: -300N/-1000N, 1Hz, sinusoidal
 8h: -300N, static relaxation
 load steps -1000N, -2000N, -3000N
 10° angulation
 Test condition + 37°C in water
 External displacement sensor sensitivity ±1µm