Our New Product Development service helps clients accelerate their product from design concept to regulatory approval.

How Product Development can help

Our team of engineers, scientists and regulatory professionals with expertise in developing next generation nicotine delivery systems and medical devices work within an entrepreneurial and agile framework to deliver rapid success to clients across the industry.

Working in close partnership with clients, our energized and passionate team thrive to deliver high qualitative solutions through scientific excellence to accelerate safer nicotine-delivery products to market; advancing a smoke free future.

What does Product Development involve?

You will have access to a dedicated project management team with leading scientific consultants across all workstreams, backed by Broughton’s premium-quality laboratory operations.  The initial product development planning is broken down into four simple stages:

Toxicology Infographic_D1

Initiation

The Initiation stage focuses on understanding project needs – your product, product design and regulatory pathway. This is an important stage in determining the design Input requirements in the form of a design matrix, to be used as a reference point to ensure development studies are appropriate for your needs. The key areas within the Initiation stage are:

  • Product Familiarization
  • Product Design Familiarization
  • Design Control Planning
  • Project Planning
  • Regulatory Planning
  • Market Claim Substantiation Plan 

 

Formulation and Design Assessment

Laboratory-based analysis is performed by our scientists on the hardware components and operating parameters to aid data driven design decisions and identify the correlation between the two variables.

The following aspects assist in comparing design options or assessing the feasibility of the proposed design, in relation to your outline requirements and regulatory obligations.

  • Levels of HPHC’s
  • Initial Toxicology Assessment of preferred components
  • Ageing data

A Design Failure Modes Risk Assessment reviews the potential failures and subsequent risk to the end user. This stage of Product Development will provide the basis for development studies and the approaches taken to ensure risk management is at the forefront of any product design decisions.

The key areas within the Formulation and Design Assessment stage are:

  • Product Design Failure Modes and Effects Analysis (FMEA)
  • Product Analysis
  • Toxicology Screen
  • Clinical Assessment

 

Safety and Manufacturing Assessment

There are two fundamental areas for assessment within the safety and manufacturing stage of Product Development which take into consideration all information obtained during the Design Assessment phase of your product:

Device/e-Liquid Formulation Safety to determine if any potential safety risks (toxicological, operational) are identified for your product. These Studies help to mitigate product safety risks in the proposed designs and provide you with valuable data with which to make a final product design decision.

 

Safety Assessment Diagram:

Toxicology Infographic_D2

 

Manufacturing and Quality Gap Assessment

Manufacturing and Quality Gap Assessment reviews your current quality management system and proposed manufacturing controls/process and outlines any potential gaps against regulatory requirements to include:

  • Initial desktop review of supply chain and manufacturing process and controls
  • Desktop review of quality systems
  • Identification of knowledge gaps
  • Quality Management System
  • Manufacturing - process and controls
  • Raw material and final product control
  • Audits and Complaints review
  • Product Supply Chain map

Scientific Strategy and Consultancy

Our scientific strategy encompasses all the information collected through the key stages above to develop the appropriate study designs for your product, supported through dedicated Project Management. Our subject matter experts have years of industry experience and are up to date with the latest ENDS regulatory landscape.

The Broughton team are ready to provide full-service guidance and support for your regulatory submission.  

A fully integrated approach 

Our team of experts, with their collective years of experience in the ENDS sector, including regulatory expertise, registered toxicologists, dedicated development and validation scientists, and an ENDS dedicated experienced analytical team, are focused purely on this industry and have the level of understanding required to design your study with you to maximize the efficiency and value of the testing.

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Resources

Leaflet

Overview of our full-service PMTA compliance solution, from planning through to compilation and submission.

Guide

Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.

Leaflet

Download our leaflet for an overview of our comprehensive services to support the ENDS industry from regulatory submission to maintaining compliance.