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Product Understanding

Product understanding is a cost-effective way to ensure the right decisions are made about your product at the right time from either a strategic or investment perspective.

 

Technical Due Diligence
Broughton’s Technical Due Diligence service helps clients by assessing a product to see if it meets expectations at key milestones in the product development process to better inform decision making and investment choices. Ensuring a new product meets the needs of the end-users, regulators and the market is critical when making decisions at key moments in any project. The service offering is suited for large-scale companies, mid-size organizations, or smaller-scale start-up companies seeking:
  • Verification assessment of a product/technology
  • Advice on a product development roadblock
  • Insight into regulatory requirements
We can help by providing an independent and impartial assessment to assist a client with an investment or acquisition opportunity or to supplement their internal product development activities in the areas of:
  • Active ingredient formulation
  • Novel technologies
  • Delivery mechanisms
  • Device hardware
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Technical Due Diligence

Learn how we can help reduce costs and increase speed by enabling the right decision at key moments to avoid costly mistakes, delays, or reworks later in the project.

Through Technical Due Diligence activities, Broughton supports clients with two clearly defined Product Assessment packages – The Fast Track and The Deep Dive.

TECHNICAL DUE DILIGENCE IS OFFERED IN TWO STANDARD SERVICE PACKAGES AND AS STANDALONE MODULES.
The Fast Track

The Fast Track is a top-level overview that identifies any red flags in product functionality that clients need to be aware of before progressing the project further. This fast turnaround service includes a top-level report and detailed analysis of activities outlined below to help save time and money later in the project.

The following activities are performed within a two-week period:

SpecReview
Specification Review
BOMAssessment
BOM Assessment
InitialCMRScreen
Initial CMR Screen
InitialFunctionaAnalysis
Initial Functional Analysis
ProductSampleVeri
Product Sample Verification
UserExperience
User Experience
TechDocAssement
Technical Documentation Review
ManuAssesment-1
Manufacturing Assessment
CompAnalysis-1
Competitor / Comparator Analysis
RegulatoryLandscape
Regulatory Landscape
fast-track-booklet
Case Study Scenario: The Fast Track

Learn more about how our Technical Due Diligence Fast Track service can help your business identify any weaknesses or gaps in the early stages of product development to better inform decision-making and investment choices.

The Deep Dive

The Deep Dive is a more in-depth investigation and testing to substantiate claims, confirm functionality and performance and develop a non-clinical strategy to be used for regulatory approval. This intensive service will further identify any potential obstacles or challenges to overcome in your project and provide all the necessary information to make an informed decision supported by a team of technical, scientific, and regulatory experts.

The following activities are performed within a two to four-month period dependent on client requirements:

TechDocAssement
Technical Document Assessment
StabilityTest
Stability Testing
E&LTesting
Extractables and Leachables Testing
ToxAssessment
Toxicology Assessment
ToxicologyTest
Toxicology Test Strategy
AdditionalFunction
Additional Functional Analysis
Electrical
Electrical Characterization
SafetyTest
Safety Testing
StressTest
Stress Testing
UserExperience-1
User Experience
CompAnalysis-1
Benchmarking Competitor / Comparator Product
USPClaimTest
USP/Claim Substantiation Testing
deep-dive-booklet
Case Study Scenario:
The Deep Dive

Learn more about how our Technical Due Diligence Deep Dive service can offer an in-depth investigation of a product’s development status to ensure informed decision-making and better investment choices.

Stand-alone Service Modules

In addition to the packages, Broughton offers the following flexible stand-alone service modules:

  • Product Assessment
  • Product Market Review
  • Product Tear Down
  • Manufacturing Assessment
  • Functional Testing
  • Toxicology Assessment
  • Stability Testing
  • USP Testing
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Product Specification

Broughton’s Product Specification service provides support for defining a product specification and a blueprint to help define, measure, and evaluate the applicability of a product for a chosen regulatory pathway.

The service includes:

  • Review of the proposed product specification document
  • Creation of the product specification documentation
  • Providing advice, or creating Summary Technical Documentation (STED)
  • Propose a test plan for evaluating proposed products against defined specifications

 

Functional Evaluation

Broughton’s Functional Evaluation service can assist with evaluating your product and assessing how it performs against consumer, regulatory, or industry requirements to ensure all regulatory obligations are met. Getting your product evaluation right from the start is essential.

Our service includes:

  • Proposed functional test plan
  • Creating detailed test protocols/methods
  • Developing bespoke test equipment, or modifying existing equipment
  • Confirming the electrical characterization of the product
  • USP testing – unique test methods created to verify any claimed performance benefits
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Comparator Studies

Comparator studies identifies the USPs of your product through in-depth comparison research into the technology and performance of competitor products. This benchmark intelligence is an efficient way to ensure your product will be competitive in the market.

The service includes:

  • Identifying comparator/competitor products
  • Evaluating ‘technical insights’
  • Establishing and reviewing the key marketing messages
  • Commercial benchmarking
  • Detailed summary of the overall comparison between your product