Give your medical device a proper FDA submission with these 3 keys
It's stressful. If you're a startup, your company depends on it: it's your FDA panel meeting. And, as Michael C. Morton, the vice president of global regulatory affairs at Medtronic (MDT), said, "It's kinda culminated with throwing the dice."
In the "How to Avoid Making a Bad Submission to the FDA..." panel at Advamed 2013 yesterday, Morton compared the process to Vegas. But he said you can improve your chances of success by applying these three tactics:
1. Have a scalable regulatory strategy.
- Panel review increases an already large workload. It might be a good idea to look for independent project managers outside the regulatory function.
- Assign roles and responsibilities. The FDA process will get your team excited (and rightfully so), but, as Morton said, "Everyone wants to be involved, but not everyone knows what to do."
- Seek out professional help. If it fits into your budget, let the pros handle what they do best, especially AV and content experts, who may already have connections with the FDA.
2. Make a realistic budget.
- This could be the hardest task, as the lead time for a panel can vary. It could take more than a year or less than 40 days.
- If it's short, there's less time to pay and more urgency. If it's long, less budget emergencies but a need to extend the budget.
- Remember to include funds for mock panels with key opinion leaders, plus money for expert help or outside aide.
3. Deliver a compelling presentation.
- Know the FDA's position. Are you in alignment or non-alignment? State any differences of opinion respectfully.
- Don't avoid the weak points. If you do, they're sure to pick up on it and then you're on the defensive.
- "Don't leave low-hanging fruit." On simple items, such as accountability tables, make sure they add up. You don't want the panel wasting valuable time on glaring errors.
- Stay within your allotted time.