Manufacturers of medical devices and pharmaceutical packaging systems must navigate a complex landscape. Creating new products by carrying out market research, capitalizing on some competitive advantage, and successfully ushering a product concept through to development is not enough. The medical and pharmaceutical product development process demands additional attention to detail. Any biomedical product development strategy must consider the biological safety of the product offering (carcinogenicity; pyrogenicity; hemocompatibility; etc.), within the context of quality system and regulatory requirements.
At Jordi Labs, we have extensive experience in the development process of medical devices and pharmaceutical packaging systems. As part of our biological evaluation consulting services, we help companies develop new products which satisfy the needs of various stakeholders. Assistance with product development strategies is one of the core services we offer herein.
The first step of research and development (R&D) from a biological safety perspective is to clearly define your product requirements. What is the target market and what regulatory and user requirements does your product need to meet? This will help you drive product design, manufacturing, and testing decisions.
Developing successful products requires a careful balance between commerciality and safety. Hence, the material selection process is often the next hurdle for product development teams. Extreme diligence at this stage can mitigate potential biological safety risks at the earliest possible opportunity. Carrying out a dedicated risk assessment and evaluation plan is critical to ensure that product requirements will be verified and potential risks are being appropriately managed.
Looking for Support with Biological Evaluations?
At Jordi Labs, we offer a choice of pre-clinical testing services engineered to help clients bring new products to their target customers. If you need help with your product development strategy, why not contact a member of the Jordi team today?