The Right Path. With you. - 4

HELPING YOU DRIVE DEVELOPMENT SUCCESS
Our product development process addresses all elements needed for your project to
succeed - from assessing product and business viability through design control,
production, and transfer, if necessary.

PHASE II
Design &
Development

Proof of Concept - At NAGLREITERTM, we assess the viability of the product concept
and the business opportunity, bringing a risk management-based, holistic approach
that helps our clients understand early the opportunities, and the risks that lie ahead.
Definition & Feasibility - Developing initial product engineering specifications are
critical to ensuring that the design warrants further development investment.
This phase also allows us to identify strategic considerations needed for successful
product development (clinical, regulatory, packaging, reimbursement, etc.) - helping
us create the blueprint for project success.
Design & Development - During this phase, the product design is continually
refined and numerous design verification activities are conducted to ensure the design
output meets the specifications and requirements of design input. Upon approval, the
design is frozen in preparation for the ramp-up to manufacturing.

PHASE I
Deļ¬nition
& Feasibility

Validation - This critical phase validates that the final design meets clinical needs,
and that manufacturing processes are clearly defined and qualified. With these
confirmations, the product then transitions from research and development to production.
Production - While mature, fully-validated manufacturing occurs throughout this
phase, a litany of scale-up and cost reduction initiatives also take place to ensure that
product volume and cost of goods targets may be achieved.
Transfer - Unlike traditional OEM manufacturers, NAGLREITERTM executes your
project within YOUR system, which entirely eliminates the need to transfer your project
into another system, saving both time and money. However, if an event occurs within the
course of your project that requires integration into a new system (i.e. an acquisition),
NAGLREITERTM can provide all services necessary to complete a system transfer.

3

PHASE A
Proof of
Concept



Table of Contents for the Digital Edition of The Right Path. With you.

The Right Path. With you. - 1
The Right Path. With you. - 2
The Right Path. With you. - 3
The Right Path. With you. - 4
The Right Path. With you. - 5
The Right Path. With you. - 6
The Right Path. With you. - 7
The Right Path. With you. - 8
The Right Path. With you. - 9
The Right Path. With you. - 10
The Right Path. With you. - 11
The Right Path. With you. - 12
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