CMDC Labs

Product Development

Product Development

Scientific Support From Early Ideas to Better- Characterized Products

Developing a product requires more than passing a final test.

Before a product reaches commercialization, organizations may need to understand its materials, formulation, ingredients, performance, stability, biological interaction, manufacturing behavior, contaminants, failure modes, and other characteristics that can influence whether the product performs as intended.

CMDC Labs provides multidisciplinary scientific and laboratory support throughout product development.

Whether you are evaluating an early concept, comparing prototypes, investigating a formulation, selecting materials, establishing analytical methods, studying stability, preparing for verification and validation activities, or troubleshooting a product that is not performing as expected, our scientific team can help determine an appropriate approach.

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Product Development Begins With the Question

Different products require different development strategies.

A medical device startup may need to characterize materials and evaluate prototypes.

A food manufacturer may be developing a new formulation and need to understand ingredients, shelf life, microbiological behavior, or product consistency.

A biotechnology company may require specialized analytical or biological studies.

A dairy or agricultural organization may be developing or improving a product and need laboratory information about raw materials, water, contaminants, microorganisms, or product quality.

An established manufacturer may need to understand why a new version of an existing product behaves differently.

For this reason, CMDC Labs does not approach every development project with a predetermined testing package.

We begin by asking:

What are you developing?

What stage is the product currently in?

What decision will the scientific information support?

From there, relevant laboratory capabilities and scientific approaches can be identified.

Where Are You in the Product Development Process?

CMDC Labs can support appropriate projects at multiple stages of development.

Early Product Development

Turn an Idea Into a Scientific Development Plan

Early development often begins with more questions than answers.

Organizations may need to determine:

CMDC Labs can provide scientific support during early-stage evaluation to help organizations
begin generating useful information before committing to larger development programs.

Support may include:

Feasibility & Proof-of-Concept

Determine Whether the Concept Works Before Building
Around It

A promising concept still needs scientific evidence.

Proof-of-concept and feasibility work can help answer fundamental questions before an
organization commits additional resources to development.

Depending on the project, CMDC Labs may support:

The objective is not necessarily to generate final validation data.

It is to help determine whether the scientific concept, material, formulation, technology, or
approach merits further development.

Prototype Evaluation

Learn From the Product Before the Design Is Final

Prototype testing can reveal important information while changes are still practical.

Organizations may need to compare:

Scientific evaluation at this stage can help identify meaningful differences and provide data for
subsequent development decisions.

Product Characterization

Understand What You Have Built

Before determining whether a product performs as intended, it is often necessary to understand
its scientific characteristics.

Product characterization can involve multiple disciplines depending on the product.

CMDC Labs capabilities may support evaluation of:

Analytical approaches may include HPLC, LC-MS/MS, GC/GC-MS, ICP-MS, FTIR, Raman
spectroscopy, SEM, XPS, microbiological methods, cell-based assays, and other appropriate
techniques.

Material Selection & Characterization

Understand the Materials Behind Product Performance

Material choice can influence performance, durability, compatibility, manufacturing, stability,
biological interaction, and product quality.

CMDC Labs can support appropriate development projects involving:

These capabilities may help development teams compare candidate materials or understand
differences between materials already in use.

Ingredient & Raw Material Evaluation

Ingredients and raw materials can influence finished-product quality, consistency, stability,
microbiological behavior, manufacturing, and performance.

Scientific evaluation may help organizations investigate:

Comparison of multiple suppliers or material lots can be particularly useful when product
performance changes unexpectedly.

Formulation Investigation & Development

Use Scientific Data to Understand Formulation Behavior

Formulation development may require evaluation of multiple variables before a stable and
consistent product is achieved.

Scientific work may support questions involving:

When a formulation does not behave as expected, CMDC Labs can also support scientific
troubleshooting to investigate potential causes.

Comparative Product Testing

Sometimes the Most Useful Question Is: What’s
Different?

Comparative testing can provide valuable information throughout development.

Organizations may wish to compare:

The analytical approach depends on which differences are scientifically meaningful to the
development objective.

Stability & Shelf-Life Development

Understand How the Product Changes Over Time

Product performance at manufacture does not necessarily predict performance weeks, months,
or years later.

Stability and shelf-life studies can help organizations evaluate how products change under
defined conditions.

Depending on the product, relevant factors may include:

CMDC Labs can support appropriate stability and shelf-life programs as part of development or
scientific investigation.

Analytical Method Development

When an Existing Method Does Not Answer the Question

New products, unusual materials, specialized formulations, or research programs may require
an analytical approach that is not available as an established routine method.

CMDC Labs can support appropriate analytical method-development projects involving:

Method development is distinct from method validation and should be scoped according to the
intended use of the method.

Method Validation

Once an analytical method has been developed or selected, organizations may need to
demonstrate that it performs appropriately for its intended purpose.

Depending on the method and project requirements, validation may consider relevant
performance characteristics.

CMDC Labs can evaluate appropriate method-validation projects according to the intended use
and applicable project requirements.

If the resulting data will be used for regulatory submission or monitoring, applicable laboratory
qualifications and requirements must be evaluated during project qualification.

Design Verification Support

Generate Scientific Data Against Defined Requirements

As products move through development, organizations may need scientific data to evaluate
whether defined design requirements have been met.

CMDC Labs can support appropriate design-verification activities through relevant laboratory
and analytical capabilities.

Depending on the product, this may involve:

The project scope should be defined according to the organization’s requirements and intended
use of the resulting data.

Product Validation Support

Validation-related work may require scientific evidence demonstrating that products, processes,
or methods perform appropriately under defined conditions.

CMDC Labs can provide appropriate laboratory support for validation programs involving its
available scientific capabilities.

Project requirements should be reviewed before work begins, particularly when results are
intended for regulatory use.

Product Optimization & Improvement

Development Doesn’t End With the First Working Version

Scientific information can also help organizations improve existing products.

Development teams may want to:

Scientific testing can help compare alternatives and provide data for better-informed
development decisions.

When Development Becomes Troubleshooting

Product development is rarely perfectly linear.
A prototype may fail.

A formulation may become unstable.

A new supplier may change product performance.

A material may behave unexpectedly.

A manufacturing scale-up may introduce differences.

A shelf-life study may reveal degradation.

At that point, the development question becomes a troubleshooting question.

CMDC Lab’s Product Development and Scientific Troubleshooting capabilities are designed to
connect.

Rather than treating failure as separate from development, scientific investigation can help
generate information that informs the next product iteration.

Manufacturing Transition & Scale-Up Support

Understand What Changed When Production Changed

Products that perform successfully during early development can behave differently when
manufacturing conditions change.

Scale-up may introduce differences involving:

CMDC Labs can support appropriate comparative and investigative work when organizations
need to understand differences between development-stage and production-stage products.

Commercialization Readiness

Before commercialization, organizations may need to confirm that key scientific questions have
been adequately addressed.

Depending on the product and industry, considerations may include:

CMDC Labs can help evaluate appropriate scientific and laboratory needs as products move
toward commercialization.

Product Development Across Industries

CMDC Labs' multidisciplinary capabilities can support product-development questions across multiple sectors.

Medical Device & Biotechnology

Support may involve materials, surfaces, prototypes, biological response, microbiology,
analytical chemistry, characterization, verification, validation, and failure investigation.

Food & Beverage

Support may involve formulations, ingredients, microbiology, shelf life, stability, product quality,
contamination, manufacturing consistency, and product improvement.

Pharmaceutical & Life Sciences

Appropriate projects may involve analytical development, microbiology, characterization,
stability, methods, product development, and research support.

Agriculture, Dairy & Livestock

Scientific development may involve agricultural products, feed, water, ingredients, dairy
products, product quality, contaminants, and other production-related questions.

Environmental & Industrial Products

Projects may involve materials, chemicals, contaminants, water, manufacturing processes,
product characterization, and environmental performance.

Research & Innovation

Universities, startups, technology developers, and research teams may require scientific
capabilities for proof-of-concept work, product characterization, experimental studies, or
technology development.

Multidisciplinary Capabilities for Product Development

Depending on the project, CMDC Labs can draw from capabilities across:

Advanced analytical technologies may include:

The appropriate capabilities are selected according to the development question.

How a Product Development Project Begins

How a Product Development Project Begins

Step 1 — Tell Us About the Product

Describe what you are developing, the current development stage, and what you need to understand.

Step 2 — Define the Scientific Objective

What decision should the scientific information help you make?

Examples might include:

Step 3 — Project Qualification

CMDC Labs evaluates whether the project fits our scientific capabilities and laboratory qualifications.

If results are intended for submission to or monitoring by a regulatory body, applicable requirements are evaluated during qualification.

Step 4 — Develop the Scientific Approach

The project may involve one test, multiple analytical techniques, consultation, comparative studies, product characterization, experimental work, or a broader development program.

Step 5 — Generate Scientific Information

The agreed laboratory or scientific work is performed according to the project scope.

Step 6 — Use the Findings to Inform Development

Results can help support the next product-development decision and may identify additional questions requiring evaluation.

What Should You Send Us?

Useful information can include:

You do not need to have a complete development plan before contacting us.

Regulatory or Commercialization Project?

If the resulting laboratory data will be used for regulatory submission, regulatory monitoring, formal verification or validation, or another defined compliance purpose, tell us during qualification.

CMDC Labs will evaluate the applicable project requirements and whether the requested work falls within the appropriate laboratory capabilities and qualifications.

Customers do not need to determine the applicable laboratory accreditation or certification themselves.

Already Know Which Testing You Need?

If your development program already has clearly defined testing requirements, you can go directly to our laboratory services.

Need Help Determining the Development Approach?

You do not need to select every laboratory method before contacting us.

Tell us:

What are you developing?

Where are you in the development process?

What do you need to understand?

What decision are you trying to make?

Our scientific team can evaluate whether CMDC Labs has the appropriate capabilities to support the project.

Build With Better Scientific Information

Successful product development depends on asking the right scientific questions at the right time.

CMDC Labs combines multidisciplinary laboratory capabilities with scientific investigation, product-development experience, analytical expertise, and research support to help organizations better understand the products they are building.

From early feasibility through characterization, stability, verification and validation support, troubleshooting, improvement, and commercialization, scientific information can help development teams make better-informed decisions.

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