Wendy Pease recently had the opportunity to attend the MassBio program “Drugs are from Mars, Devices from Venus”. The speakers discussed how blending the development of medical devices and pharmaceuticals can be a difficult and time-consuming process, but it can also lead to life-changing breakthroughs for people with chronic or acute illnesses – for example, think of the medicated stint developed by Boston Scientific to help heart patients live longer, fuller lives.
The top considerations when looking for a way to combine pharmaceuticals and medical devices would be to:
- Make a plan – think about how the medication needs to be delivered and how a medical device can help make that delivery easier or more automated.
- Be flexible – as the development process proceeds, changes may be needed to overcome some new or unexpected obstacles.
- Work together from the start – the process should be a full collaboration between the pharmaceutical experts and medical device experts to know what is and what is not a possible solution or plan.
- Be culturally aware and sensitive – the pharmaceutical company and the medical device company will likely have different corporate cultures, and both need to be aware of the differences and willing to find common ground on which to work.
- Approval should be collaborative – approval of medical devices comes from a different department in the FDA than pharmaceutical approval. All departments and key personnel from the FDA should be included through the whole process.
In summary - although it can be more difficult to develop a drug that is administered via a medical device, the rewards and benefits can be huge for both the companies involved and the patients the device is to assist.
To read more about the event and the speakers click here.