Business Manager – Knees, Invibio Ltd

Ian Revie

MedTech BESTManaging R&D projects

Victrex Confidential

Session

Managing the team

…………….and the risks

…………….as well as the technology.

Victrex Confidential

…to transform Total Knee Arthroplasty within the next 10 years and become a leading player within the market,

offering a thin shell cartilage replacement device which optimises PEEK function for strength, ingrowth and wear

to support minimally invasive surgery.

We will do this by initially developing a partnership implant business (IKL) ………will establish a unique best in

class offering to orthopaedic companies ………... The advanced knowledge created in IKL will then be used to

……develop and supply their company specific derivative devices.

Vision setting

Initial offering – simple entry – Femur - Equivalence – technically, functionally, surgically

Variants introducing material capability – eg, bearing conformity? on-growth?

Tibia changes, exploring thin surfaces

Superiority - technically & functionally, Expanding on material capability

Thin shell bearings, MI procedures, custom devices?

Ingrowth and Regenerative options

Yea

r 1

Yea

r

10

Low cost manufacture option – metal free

knee - focus market India

High performance option –

target market USA

What does a product development look like?

Design

Process development

Process Validation

Clinical evaluation

Product launch

Prototype testingDesign specs

Process specs

Ist size completed

DHF completedClinical submissions

Last size completed

DHF completedRegulatory approvals

Design & regscompletion

Product SpecDrawings

Risk analysis

FemurPackaging

LabelsIFU

MPSProcess flowRisk analysis

FemurPackaging

LabelsIFU

Install or procure new processesMeasuring

Clean and pack

Manufacture Cell

Full manufacture specsFull inspection specs

VMPManufacture records

Inspection reports & CofC

IQOQ

PQ

Major process changes -5 -1 0 iterations

Minor process changes 2-3 runs

No process changes

G0 G1 G2 G3 G4 G5

Design Validation

PL

Design Validation

Production scale-up

Planning PMP

Knee

Customer Projects

Maxx Project (AA)

Product Dev and Val (WS1) AB

Critical Work Package (CWP1.1)

Imaging MB

Process Dev and Val (WS2)

Critical Work Package (CWP2.5)

Condyle Bruise MH

Critical Work Package (CWP2.6)

Shear at Gate NW

Critical Work Package (CWP2.7) 2ndry Operations MW

Clinical Trials (WS3) SS

Mathys (MB)

Concept de-risk (WS10) MB

Product Dev and Val (WS11) AB

Process Dev and Val (WS12) PC

Clinical Trials (WS13) SO

Platform

Business Development

Science (WS4) AB

Marketing (WS5) IR

Intellectual Property (WS6) NT

Commercial Pipeline (WS7) IR

Operational Structure

Operational Development (WSA)

MH

Quality System Development (WSB)

CV

Product Design Services Dev (WSC)

NW

Organisational Development (WSD)

VM

Business Systems Dev(WSE) IR

Planning WBSPart of wider

medical business

platform work streams

Planning

Planning

Planning

Reporting

•Why do we report• Progress

• Track and agree changes

• Prioritise

•Who do we report to• Team

• External parties

• PSC

• Management

Victrex Confidential

Commentary

• Documentation is awaiting technology completion and

handover to Maxx. Process started and expected to

complete Jan 2017

• Change of management engagement to complete design

transfer • Maxx size C remedy in review – expect earliest

completion Dec 2016. potential to extend till Q1 2017

• Change of Validation process – verify 100%

• Maxx Product completed full process PQ – 1 of 32 (6

started)

IP Claims • EU prior art challenge submission via consultant

• Patent Drafts• Second Rib Patent in draft,

• Review of potential revisability patent

• Residual Risks review• Management review planned mid Nov

• DHF completed

• Mathys contracts reviews by both external counsel

Reporting high level

Victrex Confidential

Reporting PSC

Managing scope change

• Negative change• EMAT

• £400,000 2 year development

• £25M 5 years development

• Positive change• Invibio

• 1 project – 5 years

• 4 programs for 20 plus projects – 20 years

Victrex Confidential

…to transform Total Knee Arthroplasty within the next 10 years and become a leading player within the market,

offering a thin shell cartilage replacement device which optimises PEEK function for strength, ingrowth and wear

to support minimally invasive surgery.

We will do this by initially developing a partnership implant business (IKL) ………will establish a unique best in

class offering to orthopaedic companies ………... The advanced knowledge created in IKL will then be used to

……develop and supply their company specific derivative devices.

Scope change

Cementless – Prog 2

Tibia – Prog 3

Thin shell, Custom, Regenerative – Prog 4

Year

1

Year

10

Budget – Prog 1a Premium – Prog 1b

Maxx

Femur Company 4

femur

Company 3

femur

Company 2

femur

Mathys

femur?Maxx

Knee Company 4

femur

Company 3

femur

Company 2 femur

Mathys

knee?

Mathys

Knee? Company 4

femur

Company 3

femur

Company 2 femur

Maxx

knee

Max

Tibia Company 4

femur

Company 3

femur

Company 2 femur

Company 1

Tibia

Stryker

Next Gen Company 2 Company 1

Victrex Confidential

2015 2015 2016 2017 2018 2019 2020 2021 2022 2023 2023

£3M Revenue£1M Revenue

First commercial product sale

Second Medium Co. commits to JDA

Tibia Development MAXX ???

Start Clinical Trial

Large 4 Co. commits to LOI

Mathys commits to development

Surgeons promotions at Ortho Congress

Prog 1Cemented femur

Maxx Femur

Prog 2Cementless Femur

Prog 3Tibia

Mathys femur?Company 2 Femur

Stryker Femur?Company 3 Femur?

Mathys Femur?Maxx femur

Company 2 FemurCompany 3

Maxx TibiaCompany 1 Tibia

Company 2 Tibia

Tibia Development MAXX

Company 3

Prog 4Regen/Custom

Stryker femurCompany 1 Femur

Company 2 FemurCompany 3

Scope change

The Design Process

The Design Dossier

The Design Dossier

Managing design change

• Quality system• Procedures – change control, deviation control

• Roles and responsibility (RASCI)

• Competence

• Continuous improvement (CAPA)

• The specification• Design

• Manufacture

• Inspection

Project Risk management

• Product risk• Required by ISO 13485 and MDD 93/42/ECC

• ISO 14971 – Risk management – includes FMEA

• Project risk• Product is great but the business is dead

Risk management

Product Risk management

Project Risk management

Business Manager – Knees, Invibio Ltd

Ian Revie

Q&AManaging R&D projects