Lifecycle Management for 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.
There are also weaknesses in the industry when it comes to the integration of human factors and some pharma companies are falling behind manufacturers due to lack of experience in this area and misconceptions about the importance of such considerations. In order to explore this topic in more detail,
Pharma IQ spoke exclusively to Dr. Tina Rees, Associate Director-Human Factors, Ferring International Pharmascience Center to discuss product lifecycle management and the areas where simple process improvements could make a significant difference to the overall success of a product.
The latest challenges in developing, implementing and launching combination products
The pharmaceutical regulatory model has been traditionally siloed into medical devices and drugs, but the challenge with the new generation of combination products is that they do not fit comfortably into one of these existing silos.
The lack of a well defined regulatory pathway for the latest combination products is slowing the regulatory processes and to a certain extent holding back levels of innovation in this area.
As Rees explains, geographical discrepancies also contribute to the lack of regulatory clarity in this space, “the regulatory landscape is changing and keeping up with what is required and the necessary processes to get a product approved can be challenging, particularly when working across different geographies”.
Additionally, the introduction of connected devices which link with apps and Bluetooth have introduced “a whole new layer of challenges from an IT perspective” explains Rees. This raises challenges not only in terms of regulations but also from a cyber security perspective when ensuring the product’s integrity.
Preventing misalignment between pharma and medical device companies
One of the persistent challenges in the combination products industry is the relationship between medical device manufacturers and pharmaceutical companies.
Both tend to have differing terminology, experience and mind-sets which can lead to misalignment and lack of transparency in the development and manufacturing process. Rees suggests that a key area where both organisations can learn from one another is in the integration of human factors. Large medical device manufacturers, having far more experience in dealing with this element, can assist Pharma in integrating these factors into the development process.
“Pharma companies are challenged with trying to fit human factors into their already set development plans” explains Rees, “as medical device companies are more experienced in this area, it would therefore be helpful for them to communicate to their pharma counterparts how they have introduced these factors early on in the design process”.
Human factors in some cases are surrounded by misconceptions of their importance, with some believing they are simply a ‘regulatory check box’ at the end of the process. However, Rees explains that “human factors are intended to be used throughout the entire development process, but most importantly at the beginning of the design process”. The more awareness that both pharma and medical device manufacturers have about the usefulness of human factors early in the combination product design process, “the better off everybody’s products will be” says Rees.