Product Development Process

The development and commercialization of a biopesticide is an expensive and time-consuming process. Biocontrol product developers are dealing with a complicated project in which a living organism is the key element. Such a project entails many phases where each phase is a research project by itself, and successive phases are strongly interconnected. The new product development project often involves the development of new technology, and presents a highly complex matrix of biological, technical, regulatory and commercial challenges. A continuous feedback within the multi-disciplinary project team, with persons with biological skills, technical skills, and market knowledge, is required in order to optimize time and resources. Along the way, numerous decisions have to be taken on hundreds of subjects. The entire process will take many years and costs many millions of Euros. In a business environment, the ultimate objective is to sell the product in such a way that sufficient revenues are generated to achieve return on investment, and to make a profit that allows the company to develop more products, to accomplish a strong position in the marketplace, and to become a sustainable and profitable enterprise. Ultimately, the financial aspects of the product development are determinative for a company. This requires an accurate development and business plan that addresses all steps in a systematic way and that focuses on a cost-effective product that brings the grower an effective solution and meets his expectations. The path to the market is full of obstacles, and a potential product can fail at any point along the way. The time period from idea-to-launch should be as short as possible, and the required budget as low as possible. These are crucial business elements. The time from market introduction to sales volume is the other relevant phase where return on investment should be achieved. The biocontrol industry is small and young, often new players "invent the wheel again", and time and money are lost. Therefore, there is a need for a general pathway that describes all phases including the critical steps and decisions that guides an enterprise through the development of new products in an optimal way.

The principal aim of this book is to examine and evaluate the current situation, to understand why projects and products fail, to understand the needs of the market, and to examine what knowledge, techniques and resources are required to improve the development of a microbial pest control product. With this understanding I will develop a complete and structured roadmap for the successful development and commercialization of a microbial pest control product for the control of insect and mite pests. All subjects will be covered, from the identification and description of the pest problem for which a solution is needed, to successfully selling the product. The emphasis will be on the entire process of development and commercialization from a business point of view. Economic considerations will be highlighted, next to biological, technical and regulatory aspects. Special emphasis is given on criteria for decisions that have to be made continuously in such a complex process. A systematic approach is provided in which each phase is elaborately discussed, and for each step relevant considerations and decision criteria will be presented along with useful recommendations.

This pathway will be divided in the following processes: selection of the microbial agent, production and product development, quality control, registration, implementation, and commercialization. Other topics treated are referring to these processes:

• identification of selection criteria for a microbial pest control agent;

• identification of critical parameters in production and product development;

• establishment of a reliable quality control procedure;

• recommendations for the generation of a registration dossier, and a review of other relevant regulations;

• identification of the most important issues with regard to successful implementation of a new product in an Integrated Pest Management (IPM) system;

• identification of critical success and failure factors in the commercialization of a microbial pest control product, and identification of the most successful business model;

• and a synthesis of the processes that will facilitate the product development and commercialization.

Each process will be considered in detail in the consecutive chapters. Both product-related and company-related factors will be treated. Information available in the literature, from academia as well as from industrial scientists, will be reviewed and analyzed. Key elements and considerations will be identified and highlighted. Decision criteria will be defined and outlined, alongside with transparent tools that help take the right decisions. Requirements and recommendations will be provided, both for the new product and the company, to increase the chance of a successful outcome. In the last chapter a synthesis will be provided along with flow diagrams that illustrate the various steps and interconnections between phases in a structured way. These diagrams present the roadmap from idea to successful marketing of the product. This proposed systematic roadmap should facilitate the development and commercialization of new microbial pest control products, and provide guidance for entrepreneurs who contemplate to initiate activities in this field of biopesticides. Ultimately, it may increase the chances for success in the market for newly developed microbials. A future outlook for biopesticides will be provided based on the current market and society developments.

I focus on microbial pesticides that are based on entomopathogenic bacteria, fungi, baculoviruses, and nematodes. Protozoa are only briefly mentioned since they are rarely used as a control agent for a biopesticide. Furthermore, I emphasize the situation in Europe, particularly with reference to registration, and products developed for use in protected crops. The systematic approach, however, could also be applied for other microbial products for control of plant diseases, post-harvest diseases, weeds and other pest organisms. This approach is also relevant for biocontrol products developed for other markets. It could even be used in the development of a plant protection product based on natural substances, plant extracts, pheromones, and others. Many developmental and commercial factors are similar for each type of pesticide, including even chemical pesticides.

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