Recently, there have been many discussions on the topic of outsourcing. Finding a CRO that suits your needs may sometimes feel like a fruitless task, especially in the case of medical device companies, where they have a more limited variety of CROs from which to choose. Additionally, many CROs are rather pharma focused and don't have the required knowledge of medical devices. It is, however, not my intention to question their capabilities or to generalise all CROs.
Nevertheless, the fact remains that in order to successfully outsource your clinical study, you must navigate numerous obstacles. Chief among them is funding. The primary issue boils down to finding suitable investors that will fund your trial.
So what challenges do sponsors face in finding an investor? First and foremost, it's difficult to persuade potential investors to provide enough money that will see out a trial from start to finish. Therefore, the simplest and most effective way of finding investors is by drawing on your network of friends and other professionals you know. Furthermore, understanding the needs of your trial enables you to gauge the amount of funding you will need. If you can demonstrate to a prospective investor how and where the money will be spent, the chances of you gaining the required funding improves significantly.
Now, there may be other possible issues delaying your medical device launch, like communication between you, your CRO and the end-user. Let's face it, we are all humans and not everyone may be as motivated about your product as you are. From the end-user's perspective, a doctor may not have it as their priority to test your device. This creates a situation where you might have to pick up the phone and chase your end-users to ensure your product is being used. Building personal relationships with end-users is the best solution to ensure that they understand the importance behind your medical device.
While the well-being of patients is the number one priority, it is important to understand that medical devices are created to improve the conditions of patients while making their lives easier. Although they are certainly interested and very eager in joining the study at the beginning, over time, patients can have a tendency to lose focus as it is not their priority. For sponsors, the concern here is running behind schedule. Especially if you are conducting clinical trials and the product launch is fast on the horizon. Therefore, be sure to do a robust testing immediately after the product launch.
So my advice is, if you wish to conduct a trial, contract as many doctors and labs as possible. And as the contract is not binding forever, you may abandon it anytime. Obviously, the doctors sign a contract that ensures they fulfil their obligations to the best of their ability. However, it does not commit them to recruit a specific number of patients needed for any given trial. Therefore, be sure to provide incentives to end-users that enhances your chances of a successfully conducted medical device trial.