Ulmer Ventures

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Why you should talk to the FDA (part 2)

6. You crystalize your claims

The most aggressive claims in the labeling get reviewed by an outside party and receive the imprementeur of United States Federal government. It compels the team to research the very best evidence to support the most important marketing claims. This evidence (ex: peer-reviewed literature) may be used by the sales team to make the very strongest value selling points.

7. You get out of the business of selling an investigational device

The first two years of many MedTech companies that are in revenue may be spent conducting paid pilots. They are also likely pre-FDA clearance/approval. During this time, the management team has to engage in complex negotiations with providers in non-significant risk “IRB” or significant risk IDE studies in order to show traction. The early FDA feedback allows the company to move as quickly as possible to clearance by designing the most capital efficient study and the promise of a less complex B2B sales process post-clearance/approval.

8. You drive more accurate forecasting

The main cost drivers of a product launch include engineering testing, large animal studies and clinical trial conduct. The specific questions typically posed in Pre-Submissions center on these three topics. Written feedback on the most appropriate bench tests, number of animals required in a safety study and clinical study design  empower the management team to get more accurate and granular estimates from service providers.

9. You gain the most current thinking on your device’s risk/benefit profile

For the most cutting edge technology, your risk/benefit assessment can be repurposed to differentiate your device in the market.  The process of thinking through - and potentially quantifying - clinical benefit allows the business leader to share an even crisper message to stakeholders.

10. You get an objective set of facts for management review

If a company is operational, the written feedback from the FDA provides for a richer discussion during management review.  The goal of a management review is to consider the health of an organization through various lenses (ex: regulatory). A clear set of preclinical and clinical requirements enable more productive conversations between research and development, operations, marketing, and sales.

Kwame Ulmer