Product Development Technology, Inc. is a consulting firm that helps medical device companies navigate product development. They provide hands-on support to CEOs and management teams in areas like product design, production engineering, quality systems, and regulatory compliance. Their on-site consultants draw from decades of experience in medical product development to help clients integrate teams, design first products, establish processes, and prepare for commercialization and market entry.

1. PRODUCT
DEVELOPMENT
TECHNOLOGY, INC.
Does your early-stage or late-stage medical
technology venture need assistance in
getting your ‘first product’ out of development
and into production?
We specialize in finding the best path
through the ‘Product Development Labyrinth’.
Product
Specification
Process
Production Quality
Engineering Engineering
Process Process
PRODUCT Product
Engineering
COMMERCIAL
CONCEPT Clinical
Process
Regulatory
PRODUCT
Evaluation Compliance
Process Process
Supplier
Development
Process
Product develoPment
labyrinth
We serve as a temporary on-site executive
resource to the Chief Executive Officer and
his/her Management Team, acting as a
hands-on advisor, collaborator, facilitator,
manager or individual contributor.

2. Our customer relationships begin with
the CEO or Venture Partner . . .
• Founding CEO of a transdermal
patch developer, experienced in drug
products, needed to plan and complete
medical device development tasks.
• Founding CEO of a transdermal patch
developer needed hands-on support for
Materials Director in preparing supply
chain for commercialization.
• Founder and CEO of a cardiac
equipment developer needed hands-on
support for Operations VP in evaluating
next generation product prototype.
• Founding CEO of a safety syringe
developer needed product team to
complete product design and production
equipment development.
• Founding CEO of a safety products
developer, unfamiliar with medical
products market, needed hands-
on support in product engineering,
production equipment and component
sourcing.
• Venture Partner and CEO of a fiber optic
technology developer needed product
due diligence and interim supervisor for
product development department.
• Turnaround CEO of a safety blood
collection developer needed to
resolve product quality crisis with key
component supplier.

3. . . . with completion of the following
consulting engagements:
• Conducted a due diligence review
of new product opportunity and its
development organization.
• Critiqued and expanded initial
planning and milestones for product
development.
• Identified and recruited missing
resources needed to expedite internal
product development.
• Coordinated external contractors
in product design and pilot process
development.
• Developed systems and procedures
for product engineering, manufacturing
development and quality systems
integration.
• Developed and implemented
management reporting systems to
gauge progress in product development.
• Assumed temporary management
responsibility for several aspects of
product development cycle inside
company.
• Developed and tracked product cost
buildup during product and process
development cycle.
• Streamlined complex supply chain
to improve lead-time and unit cost
parameters.
• Designed and built working prototypes
for bench testing and animal clinical
studies.

4. We understand the challenges faced by
today’s Chief Executive Officer to . . .
. . . integrate a first-time team
. . . design a first-time product
. . . follow a first-time process
. . . prepare a first-time market
. . . foster a first-time culture.
Our brand of consulting is on-site and hands-
on, working closely with the Chief Executive
Officer and his/her Management Team. We
find that being on-site allows us to quickly
understand the problems, obstacles, players
and culture. Consequently, we can work
more effectively and efficiently with the client,
adapting to changes in direction, as new
information is uncovered.
We are particularly agile, quickly grasping
the client’s situation, becoming a trusted
advisor and team member, anticipating critical
next steps, and identifying hidden obstacles
to success. Our many years of exposure
to different products, systems and cultures
provide us with reliable foresight.

5. Robert Stathopulos is the Founder
and Principal Consultant for Product
Development Technology, Inc., a
consulting alliance that specializes in
assisting early-stage and late-stage medical
technology ventures through the ‘Product
Development Labyrinth’.
He has over 30 years
experience in product
design, prototype
development,
assembly methods and
inspection strategy for
medical products.
Bob received his apprenticeship in product
and process engineering with Becton
Dickinson, Davis & Geck and Johnson
& Johnson. He has worked with several
medical technology start-up ventures over
the last 15 years, as a technical consultant,
interim executive or full-time manager. Bob
has bachelor’s and master’s degrees in
engineering.
For more information, read Bob’s executive
profile on www.LinkedIn.com.

6. PRODUCT
DEVELOPMENT
TECHNOLOGY, INC.
Phone 973.214.7009
Email rstat@optonline.net