Generic Product Development Key steps l Discovery l Product Definition l Business Case Development l Project feasibility

                                         

Generic Product Development Key steps

 

What is the Product Development Process?

A Product Development Process refers to the entire range of activities where a company conceptualizes and realizes a new offering.

A product concept might originate in the marketplace, or in a lab or workspace. Product development usually follows a process divided into stages, phases or steps, by which a company conceives a new product idea and then researches, plans, designs, prototypes, and tests it, before launching it into the market.

 

A typical product development process can be classified as below

Step 1: Discovery (Product Idea)

Step 2: Product Definition

Step 3: Business Case Development

Step 4: Project feasibility

Step 5: Formulation and process development

Step 6: Pilot Bioequivalence Study

Step 7: Submission / Validation Batch Manufacturing

Step 8: Pivotal Bioequivalence Study

Step 9: Dossier Filling

Step 10: Post Dossier Filling

Step 11: Commercial Launch

Step 12: Post approval Changes/ Life Cycle Management

 

Step 1: Discovery

This first step or stage of the new product development/ product development process, often called “Ideation,” is where new product concepts originate. Often, a company forms a small team to explore the idea generation and initial definition of the product, perform market research, and to explore its technical and market risk. The idea stage is often the most important step for new products because it is where most product ideas come from and this casts the die for the development. Getting the product concept wrong at this early stage wastes time and increases opportunity cost.  Note, that the Discovery stage is often the most challenging and a product development checklist can be used to pinpoint risks in this stage and throughout the rest of development.

 

Step 2: Product Definition

Sometimes called “scoping,” this phase involves refining the definition of the product. The team creates the first detailed assessment of the technical, market and business aspects of the new product concept. Developers and managers explore and define the key points of differentiation for the new product. This second step in the new product development process, if done improperly, can increase time to market or cause the product to misunderstand the needs of the market.

 

Step 3: Business Case Development

This step justifies the company’s investment in the development of a product by requiring the team to create a detailed business plan. This plan usually involves intensive market research. The team thoroughly explores the competitive landscape for the new product and where the proposed product fits within it, while also creating a financial model for the new offering that makes assumptions about market share. The team also considers the commercial manufacturability of the proposed new product.

By the end of this phase, Senior Management should have a clear idea of what they are investing in and how it will perform in the marketplace. This third step in the product development process is critical because it reduces the market risk for the new product.

 

Step 4: Project feasibility

Feasibility describes how easy or difficult it is to do something. Various types of feasibility that are commonly considered include technical feasibility, operational feasibility. Assessment of Right level/ experience scientist/people and existing/available equipment in the laboratory are the key focus points in this step. As per the project demands, procurement of advance/new equipment, collaboration with outside laboratory or 3^rd party manufacturer/development laboratory assessment shall be performed/finalized. Laboratory design to be assessed against the classification of molecule of interest (based on the potency).

Safety for the scientist is one of the prime goals for any pharmaceutical organization. Risk assessment experts use their professional judgment to interpret data and generate critical effect risk-based values, including OELs and occupational exposure bands (OEBs). These assessments allow a R&D/ manufacturing facility and its management team to put engineering and industrial hygiene strategies in place to control and minimize the risk of exposure. As well as training, these will include containment and personal protective equipment (PPE) strategies.