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7 August 2015 MEDT15-P-001 v2.2
7 August 2015 MEDT15-P-001 v2.2
7 August 2015 MEDT15-P-001 v2.2
Translating technology into commercially
successful medical products Why having a good technology is not enough
Lucy Rowbotham
MedTech Connect 2 July 2015
7 August 2015 MEDT15-P-001 v2.2 3
New and innovative technologies can create great new products – but is having
a good technology enough?
7 August 2015 MEDT15-P-001 v2.2 4
To gain regulatory approval, medical products must be designed and developed
using a Quality Management System compliant with eg ISO 13485 or 21 CFR 820
Our Medical Development Process (“MDP”) defines how and when all design
inputs and outputs should be created and is compliant with both
IDENTIFY
Understand
requirements
Generate
& assess
concepts
BUILD
DESIGN
VERIFY & VALIDATE Specify
verification
& validation
protocols
Conduct
formal
verification
Conduct
design
validation
Support
clinical
trials
,
Design
review
2
Design
review
3 Change
Control Board
Review
Design
review
6
Select
suppliers
Build
first-offs
Integrate
system
Build
validation/
clinical trial
batches
Transfer
design
Design
review
5
Design
system
architecture
Create
detailed
design
Process
optimisation
& validation
Build
formal
verification
batches
Verify
innovations
Verify Design &
System Integration
and Refine Design
Design
review
4 SUPPORT
Installation
&
servicing
Maintain
design
Research &
analyse
requirements
Assess
requirements
risk
Production
Collate documentation
& plans
Design
review
1
7 August 2015 MEDT15-P-001 v2.2 5
IDENTIFY
Understand
requirements
Generate
& assess
concepts
BUILD
DESIGN
VERIFY & VALIDATE Specify
verification
& validation
protocols
Conduct
formal
verification
Conduct
design
validation
Support
clinical
trials
,
Design
review
2
Design
review
3 Change
Control Board
Review
Design
review
6
Select
suppliers
Build
first-offs
Integrate
system
Build
validation/
clinical trial
batches
Transfer
design
Design
review
5
Design
system
architecture
Create
detailed
design
Process
optimisation
& validation
Build
formal
verification
batches
Verify
innovations
Verify Design &
System Integration
and Refine Design
Design
review
4 SUPPORT
Installation
&
servicing
Maintain
design
Research &
analyse
requirements
Assess
requirements
risk
Production
Collate documentation
& plans
Design
review
1
Medical product development is very demanding and complex. Today, we will
discuss how to overcome some of the challenges, focusing on the IDENTIFY stage
DESIGN
Challenge for Thermocore
VERIFY & VALIDATE
Challenge for Philips
BUILD
Challenge for Chiesi IDENTIFY
Challenges for Lifeline
7 August 2015 MEDT15-P-001 v2.2 6
Philips acquired Lifeline as part of their Home Wellness strategy for growth
Lifeline is the leading provider of personal response & emergency call systems
in the US and Canada
Every 2.3 seconds an older adult over the age of 65 will fall in US
Seniors using Lifeline’s 24hr service can press a button to send an alert to a
monitoring centre – which responds with assistance
Lifeline has in-depth knowledge of a successful service model
Philips asked us to help them to create innovation
that could be applied to accelerate the
growth of the business via
“technology enabled services”
We managed a joint Europe/US
Philips/Lifeline team for a project
to identify the right concept
IDENTIFY
Challenges for Lifeline
7 August 2015 MEDT15-P-001 v2.2 7
IDENTIFYING a link between a technology and a patient need is not enough –
the way that need is met is critical to success and should be explored early
Seniors were interviewed and visited at home to understand aspects of falls
IDENTIFY
Challenges for Lifeline
7 August 2015 MEDT15-P-001 v2.2 8
A high tech solution such as “Activities of Daily Life Monitoring” requires
professional installation, whereas a pendant and single base station does not
Example setup installed in a 2-bedroom apartment
(sensor boxes indicated with red circles). From A Web-Based Non-Intrusive Ambient System to Measure and
Classify Activities of Daily Living
OR
IDENTIFY
Challenges for Lifeline
7 August 2015 MEDT15-P-001 v2.2 9
Five robust concepts were IDENTIFIED, including an emergency pendant which
automatically detects a fall, without the Senior pressing a button
5 robust concepts identified:
– Concepts A, B, C, D and E.
Concept E (HomeSafe)
– the only pendant-style help button that
can automatically place a call for help if it
detects a fall and you're unable to push the
button yourself.
– has patented technology involving multiple
sensors - both acceleration & height
– communicates to a base station in the home
– wear it in the shower, where falls often occur,
as it's waterproof
– easy to install
IDENTIFY
Challenges for Lifeline
7 August 2015 MEDT15-P-001 v2.2 10
But meeting the patient need in the right way is not enough – the needs of
carers and Referral Sources (Healthcare Professionals) must also be met
User
Research
Response
from 500
Seniors
Response
from 300
Caregivers
Response from
20 Healthcare
Professionals
Revenue Develop
for
Launch?
Concept A ~ Monthly payment No
Concept B ~ ~ Monthly payment No
Concept C Monthly payment No
Concept D One-off payment Yes
HomeSafe ~$45 per month Yes
IDENTIFY
Challenges for Lifeline
7 August 2015 MEDT15-P-001 v2.2 11
Meeting user needs with a technical solution is not enough - to get leading edge
competitive solutions you need passion, persistence & access to global knowhow:
We managed a team of experts
located in US, UK, Austria and
Netherlands
Everyone laughed at the solution
initially:
– Combining accelerometer
data with altimeter data
appeared unfeasible
– The team persisted
– It now achieves 95%
detection of falls –
market leading performance
Multiple inputs were critical to
create a feasible solution
IDENTIFY
Challenges for Lifeline
NEW DELHI
TOKYO
SINGAPORE
CAMBRIDGE
BOSTON
7 August 2015 MEDT15-P-001 v2.2 12
50% of new customers recognize the value of the HomeSafe with AutoAlert service
IDENTIFY
Challenges for Lifeline
7 August 2015 MEDT15-P-001 v2.2 13
Thermocore had already completed the IDENTIFY stage for a system to
diagnose vulnerable plaque but needed help with the DESIGN
Thermocore Medical Systems sought to develop a
thermography system to detect vulnerable plaque by:
– incorporating sensitive temperature sensors
into a catheter and
– monitoring the temperature as the catheter is
slowly withdrawn to
– create a map of the interior temperature of
coronary arteries
Thermocore’s ambition was to announce European
regulatory approval – a CE mark - ahead of their
competitors
Technically challenging
Risk mitigation was key
DESIGN
Challenge for Thermocore
7 August 2015 MEDT15-P-001 v2.2 14
Having a market leading technical solution is not enough - For the DESIGN to
meet the Essential Requirements, the relevant standards must be addressed
Essential Requirements Template (1 page of 37)
Human Factors Engineer
Risk Management Specialist
Electronics Engineer
Industrial Designer
DESIGN
Challenge for Thermocore
concept to clinical trials in 12 months
concept to CE Mark in 18 months
7 August 2015 MEDT15-P-001 v2.2 15
Knowing what Essential Requirements must be met is not enough – you have to
demonstrate many requirements via Design Verification Testing
To succeed you need to start key activities early
IDENTIFY
Understand
requirements
Generate
& assess
concepts
BUILD
DESIGN
VERIFY & VALIDATE Specify
verification
& validation
protocols
Conduct
formal
verification
Conduct
design
validation
Support
clinical
trials
,
Design
review
2
Design
review
3 Change
Control Board
Review
Design
review
6
Select
suppliers
Build
first-offs
Integrate
system
Build
validation/
clinical trial
batches
Transfer
design
Design
review
5
Design
system
architecture
Create
detailed
design
Process
optimisation
& validation
Build
formal
verification
batches
Verify
innovations
Verify Design &
System Integration
and Refine Design
Design
review
4 SUPPORT
Installation
&
servicing
Maintain
design
Research &
analyse
requirements
Assess
requirements
risk
Production
Collate documentation
& plans
Design
review
1
Specify
verification
& validation
protocols
Conduct
formal
verification
Freeze
Design
VERIFY & VALIDATE
Challenge for Philips
7 August 2015 MEDT15-P-001 v2.2 16
After helping Philips Lifeline to IDENTIFY the concept for HomeSafe, they asked
us to help them develop and VERIFY their prototype design for GoSafe
GoSafe is a new mobile personal emergency
response system – it works outside the home
Access to help through a simple, easy-to-wear,
waterproof button.
AutoAlert fall detection
Two-Way Voice Communication right from
the GoSafe pendant.
Six location technologies designed to help
locate the user in a variety of situations:
– home or away,
– indoors and out.
Philips had prototype electronics and
mechanics design – we added the software
& industrialised
VERIFY & VALIDATE
Challenge for Philips
7 August 2015 MEDT15-P-001 v2.2 17
We VERIFIED the complex GoSafe medical system for the US, EU and other
international markets
short range radio
DECT radio
cellular radio
microphone and
loudspeaker,
working simultaneously
Wi-Fi
GPS
Intelligent tracker
Linking with:
– up to 9 buttons
– the users
– and the call centre
multiple locations (inside,
outside, at home, remote)
VERIFY & VALIDATE
Challenge for Philips
7 August 2015 MEDT15-P-001 v2.2 18
Testing to show that you have met standards is not enough – equipment and
test methods must also meet standards
Stargate 64 –
our anechoic
radio test
facility
VERIFY & VALIDATE
Challenge for Philips
7 August 2015 MEDT15-P-001 v2.2 19
Dedicated Design Verification Testing capability was required for the Chiesi
NEXThaler®; a breath-actuated dry powder inhaler which delivers corticosteroid
NEXThaler ® world-class performance
Successfully launched in 4+ countries
Simple to use (open, inhale, close),
Reliable delivered-particle performance
(flow independent)
Reliable dose counter
Example of Testing equipment
BUILD
Challenge for Chiesi
7 August 2015 MEDT15-P-001 v2.2 20
But having a system that passes DVT is not enough - you need to manufacture
at the right cost in high volume which means starting BUILD activities early
Designing the right cost into a product which will be
produced at millions per annum needs to happen early:
– Identify manufacturing and assembly process
– Challenge robustness of design vs process variations
– Map supply chain
BUILD
Challenge for Chiesi
7 August 2015 MEDT15-P-001 v2.2 21
In conclusion - you have to lay the foundations for critical activities a stage
earlier than you might expect, in order to successfully overcome the challenges.
IDENTIFY
Understand
requirements
Generate
& assess
concepts
BUILD
DESIGN
VERIFY & VALIDATE Specify
verification
& validation
protocols
Conduct
formal
verification
Conduct
design
validation
Support
clinical
trials
,
Design
review
2
Design
review
3 Change
Control Board
Review
Design
review
6
Select
suppliers
Build
first-offs
Integrate
system
Build
validation/
clinical trial
batches
Transfer
design
Design
review
5
Design
system
architecture
Create
detailed
design
Process
optimisation
& validation
Build
formal
verification
batches
Verify
innovations
Verify Design &
System Integration
and Refine Design
Design
review
4 SUPPORT
Installation
&
servicing
Maintain
design
Research &
analyse
requirements
Assess
requirements
risk
Production
Collate documentation
& plans
Design
review
1
Specify
verification
& validation
protocols
Conduct
formal
verification
Freeze
Design
Process
optimisation
& validation
Process
optimisation
& validation
Process
optimisation
& validation
Conduct
design
validation
Support
clinical
trials
Verify Design &
System Integration
and Refine Design
To translate technology into commercially successful medical products
you need to look ahead to BUILD and VERIFY & VALIDATE
Proof of
value
Proof of
concept
IP
Creation
7 August 2015 MEDT15-P-001 v2.2
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