Combination Products Blog
The medical device industry continues to evolve and adapt to new regulatory standards. In this interview, Patrick Reichmann, Quality Assurance & Regulatory Affairs Manager at Agfa Healthcare, shares his view on how to address the key regulatory challenges in the industry. He also offers advice on how to meet the ISO 27000 standards and why legacy devices will be a growing security concern in the coming years.
The market for combination products is rapidly expanding, this could be attributed to the rising frequency of chronic disease such as diabetes, cardiovascular disease and treatment of allergies. These products are advancing medical care and will likely have a significant impact on the industry in the coming years. The market for these products is earmarked for growth with sources stating that the industry is likely to hit US $115 billion by 2019.
Pharma IQ sat down with Audrey Clarembeaux, Head of Medical Device Development QA at UCB to discuss the key considerations that need to be made when ensuring regulatory compliance in combination products.
Approximately one-third of all medical products in development today are combination products and this has undoubtedly introduced a new dynamic to product development and regulatory approval.
Ensuring that combination products are effectively managed throughout their development, implementation, launch and post-launch is critical to long term success in the market.
However, the interaction between medical device manufacturers and pharma companies arguably still has considerable room for improvement in the development stages, and in order to facilitate an efficient development process and launch the two partners must be fully aligned throughout the product lifecycle.