New healthcare products often begin with a technological innovation or biological insight that aims to address a need or improve current technology in the medical arena. To successfully position healthcare products in the market, product development must proceed with market, commercial and regulatory issues in mind.
Good market research and an analysis of the needs and economics of your target market are imperative to define the market potential of your innovation and develop your business plan.1 Market research and analysis enables you to:
On top of market research, the regulatory issues related to healthcare product development cannot be overlooked. In the KPMG Pharmaceutical Outlook Survey conducted in May 2012, 60% of executives said that regulatory and legislative pressures are the most significant barrier to their company’s growth over the next year.2 In addition to being aware of all the relevant industry regulations and guidance documents, it is important to identify the regulatory status or classification of other marketed healthcare products. This will guide you in positioning your product in the marketplace. The following sources offer information relating to marketed healthcare products:
Pricing and reimbursement are other factors that greatly affect the positioning of healthcare products as well as their product development. Start planning your pricing and reimbursement strategy early in the product development process. Do not wait until after a product is approved as these issues are complex due to the different systems employed in different jurisdictions.1 When structuring pricing and reimbursement for new healthcare products, it is important to know for each country:
Reimbursement planning should typically begin before clinical development of the product. It can help to:
Development of healthcare products is highly regulated. It is a long and expensive undertaking. In addition to the good science in support of the quality, safety and effectiveness of the product, factors such as market research, regulatory issues, and reimbursement and pricing strategies need to be evaluated. Such an overall appraisal will provide important feedback for the product development program. It can yield important insights to steer the positioning as well as decisions related to product design, its intended use, and the clinical trial design or types of studies that need to be conducted.1 In short, good science alone does not necessarily lead to a good product. Scientific expertise needs to be leveraged within the context of market forces in order to achieve a successful and profitable product.
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The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.
Published: October 17, 2012