Medical Device Product Development Experience and Overview (Greg Browne)

1. Product Development Leader
Program Manager
15 years of Product Development Experience
7 Years in Consumer Product Development
8 Years in Human-Centered Medical Device Design
Manages multiple cross-functional design and engineering
teams across N America
Expert in Design Management processes
Experienced system engineer
Expert in usability and user research
Expert in Agile development methodologies
Extensive knowledge of prototyping and production tech-
nologies
Mentor
Multiple Issued Patents and Design Awards
Device Concept Development
Medical Device R&D
Greg Browne Device R&D Manager/ Device Design Lead Experience
©2014 All Rights Reserved Gregory Browne. Not To Be Reproduced Without Written Permission.

2. Hands-on Knowledge Of The
What It Takes To Get A Medical
Device To Market
I have a good working knowledge of medical device
regulatory and engineering standards and have helped
formulate the product development strategies for many
Class I and II devices. My project management experience
includes leading several of these projects from conception
through to transfer and ISO 13485 manufacture.
For products to be marketed in the US, it is imperative that
one identify the reimbursement strategy and
510(k) predicates early. Regulatory Path decisions will impact
greatly on the design, engineering and execution of a new
medical product.
As a project manager I am adept at knitting regulatory needs
with the design innovation and product development process..
IEC 60601 Edition 3
IEC 60601-1
IEC 60825
IEC 62366
IEC 62304
ISO 14971
ISO 13485
HEALTH CANADA
FDA FDA 510(k)
Device Development Process
Medical Device R&D
Greg Browne Device R&D Manager/ Device Design Lead Experience
©2014 All Rights Reserved Gregory Browne. Not To Be Reproduced Without Written Permission.

3. A Broad Understanding Of The
Clinical Workplace and
End-User Needs
A human-centered approach to design and engineering
development contributes greatly to the safety and success
of a new device. FDA recall studies indicate that 44% of
medical device recalls are a result of user error linked to the
poor design of a product.
I have good working knowledge of users, protocols, equip-
ment and environments and have logged hundreds of hours
observing procedures, and working with physicians and
providers at institutions across N America.
I am an advocate of the human-centered engineering
processes and techniques described in IEC 62366:2007
and ANSI HE75 and have led qualitative and quantitative
usability studies for many different types of devices.
Cardiothoracic Surgery
Perfusion
GI Surgery
POC IVD Devices
Interventional Cardiology
IVUS
Electrophysiology
Atrial Fibrillation
Bedside Ultrasound
ER (Trauma, Critical & Acute Care)
Orthopedic Surgery
Pediatric Oncology
Hospital Pharmacy
Civilian/ Military Tactical EMS
Tissue Pathology
IV & Intrathecal Drug Injectors
Flow Cytometry Laboratories
Dental Bridge Repair
Ophthalmic Devices
IMRT Treatment
Hospital Information Systems
Credentialling & Billing
PACS and DICOMM
Users & Usability Research
Medical Device R&D
Greg Browne Device R&D Manager/ Device Design Lead Experience
©2014 All Rights Reserved Gregory Browne. Not To Be Reproduced Without Written Permission.

4. A Track Record Of Innovation
And Generation Of New IP
I relish the challenge of taking multiple inputs and turning them
into award-winning product offerings. I am a prolific inventor
who relishes tackling mechanical and software design prob-
lems. I am able to lead design teams through ideas and
lines-of-thought quickly on paper using rough proof-of-
principal prototyping methods as necessary to quickly
establish the merit of ideas. I am experienced in a variety of
different brainstorm techniques.
Elegant design thinking, innovative engineering and intuitive
usability are the results a thorough idea development process
and team effort. It is critical to get this right as it will define the
character of the final device.
Issued device patents:
2010/0298831 A1 (United States )
8,292,891 (United States )
D633,199 (United States )
WO2013105986 A2 (United States )
13/083,360 (United States )
EP2355770 A1 (Europe)
12/527,662 (United States )
13/128,795 (United States )
D680652 S1 (United States )
13/015,507 (United States )
2010/0025609 A1 (United States )
Device Innovation
Medical Device R&D
Greg Browne Device R&D Manager/ Device Design Lead Experience
©2014 All Rights Reserved Gregory Browne. Not To Be Reproduced Without Written Permission.

5. Delivering Sophisticated Design
Solutions Appropriate For
Engineering Development
Award-winning medical devices marry sophisticated
technology platforms with great usability and influences
from the consumer market. These products need to be
well-considered from the inside and out, meet user
needs, reduce user-error, provide reliable functionality
and overall to contribute to improved patient outcomes
and reduced costs.
As a design lead with a strong system engineering and
process background I am able to blend technical
engineering, innovation and human-factors inputs into
compelling designs which are economical to engineer
and manufacture.
Osseopulse Bone Regeneration System- Life Science & Medicine (Design Lead)
Red Dot Award (2010) Honourable Mention
Orga08 Modular Filing System- Offices Furniture (Design Team memeber)
Red Dot Award (2010)
Soundbug- Consumer Audio (Design Lead)
Red Dot Award (2003)- ‘Best of Best’ Product Design
Device Concept Development
Medical Device R&D
Greg Browne Device R&D Manager/ Device Design Lead Experience
©2014 All Rights Reserved Gregory Browne. Not To Be Reproduced Without Written Permission.
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6. Proof-of-Principle Prototyping
Medical Device R&D
Quick Exploration and Elimination
of Ideas Using Rapid Prototyping
Processes and Techniques
Fast-track design and innovation requires that the
design team is able to quickly work up paper ideas into
physical proof-of-principle prototypes and fixtures
which can be physically handled and tested. The
processes can vary from foam and card, SLA and FDM
to CNC machined and rapid-tooled parts. Whatever
the process, the goal these techniques is the same - to
‘fail fast’, observe and gain expanded insights.
In past projects I have rapid prototyped everything from
volumetric form-studies, precision metering mecha-
nisms, micro-fluidic wells and chambers to injection
portals and physical interfaces. Prototyping is an
important part of my process.
Greg Browne Device R&D Manager/ Device Design Lead Experience
©2014 All Rights Reserved Gregory Browne. Not To Be Reproduced Without Written Permission.

7. Usability Engineering
Medical Device R&D
Integration Of Usability Within The
Engineering Process To Meet
Regulatory Needs
Since late 2013, the FDA requires conformity with
60601 3rd Edition as an input requirement for a 510(k)
application. As such Usability Engineering processes
now form a mandatory part of the device design
development and Risk Management process.
Over the last three years I have developed multiple
SOPs related making usability a trouble-free part of the
Phase 1 process and ensuring conformity with IEC
62366 and the 3rd Edition Usability Checklist.
Usability sessions and focus groups are invaluable in
growing engineers and designers who are sometimes
inclined to have biases around the technology platform,
and little awareness of the importance of user
acceptance to the success and safety of the product.
Greg Browne Device R&D Manager/ Device Design Lead Experience
©2014 All Rights Reserved Gregory Browne. Not To Be Reproduced Without Written Permission.

8. Device Program Management
Medical Device R&D
Maintaining The Vision From
Phase 0 Through Engineering and
Manufacture
I lead cross-functional device engineering teams,
ensuring that device projects stay on plan and that
Critical Path milestones are met. Design issues which
arise are documented and addressed in an ordered
manner consistent with ISO 13485 device engineering
standards. I maintain all Risk Management documenta-
tion and the Technical File.
It is my responsibility to interface with Marketing and
Sales and to ensure that the original product vision is
sustained throughout the Phase 1 engineering process.
I have steered a number of products from design to
market including single-use vascular-access devices, a
point-of-care IVD instrument, imaging systems and
other therapy devices.
Greg Browne Device R&D Manager/ Device Design Lead Experience
©2014 All Rights Reserved Gregory Browne. Not To Be Reproduced Without Written Permission.

9. Making Users Stakeholders In
The Process To Improve The
Chance Of Device Success
Research guide documents need to be created which
are project-specific and contain all the necessary tools
and methodologies to guide the activities. These include
question guides, background information, data capture
forms as well as other guidance.
The user sessions themselves can vary significantly -
One-on-one interaction requires a more subtle approach
compared to larger group sessions, multi-site and
procedure observations. Information needed to be
logged and captured in an ordered manner suitable for
later filtering and processing.
Not only are you trying to determine what users need but
you are also building working relationships. This way the
user can become a sounding board for ideas and
prototypes through the development process.
Users & Usability Research 1.
Medical Device R&D
©2014 All Rights Reserved Gregory Browne. Not To Be Reproduced Without Written Permission.
Greg Browne Device R&D Manager/ Device Design Lead Experience

10. Discrete procedure observation and documentation of
workflow forms an integral part of the qualitative part of the
research process. Often users do not realise what they do
nor the habits that they follow when doing repetitive tasks
or in stressful situations. These insights can become golden
innovation opportunities.
Interviews and group workshop sessions provide a means
of collecting quantitative inputs from larger groups of
user-operators.
The outputs and insights attained are filtered and
processed analytically using processing methodologies
appropriate to complexity of the exercise and size of
sample.
Understanding How People Do
What They Do, When They Do it
and Why
Users & Usability Research 2.
Medical Device R&D
©2014 All Rights Reserved Gregory Browne. Not To Be Reproduced Without Written Permission.
Greg Browne Device R&D Manager/ Device Design Lead Experience

11. Deconstructing The Workspace
and Auditing The Equipment That
Operators Use
Measuring and digitising the working environment allows
design-engineers to replicate scenarios back at the office in
order role-play prototype usage scenarios.
LEAN design improvements can be discerned once the
movement of participants during a procedure is understood.
Small optimisations can make meaningful improvements in
user comfort during long procedures.
While in the working environment one should spend time
with users to audit the strengths and weaknesses of
existing tools especially competitor products and devices.
Where is it stored? How is it cleaned? Who will be respon-
sible for servicing the device?
These inputs are invaluable to future Design Requirements
documentation.
Users & Usability Research 3.
Medical Device R&D
©2014 All Rights Reserved Gregory Browne. Not To Be Reproduced Without Written Permission.
Greg Browne Device R&D Manager/ Device Design Lead Experience

12. Translating Insights and Findings
Into Practical Requirements and
Specifications
The key is to ensure that the outputs from user research
and usability studies are distilled into a clear set of
Product Definition inputs and Design Requirements so
that they might drive the engineering process. This way
the user inputs become part of Risk Management File
and findings can then be qualified during Verification
and Validation.
Users & Usability Research 4.
Medical Device R&D
©2014 All Rights Reserved Gregory Browne. Not To Be Reproduced Without Written Permission.
Greg Browne Device R&D Manager/ Device Design Lead Experience