Regulatory approval is just the beginning of your medical device journey

Attention MedTech Innovators and Entrepreneurs


Regulatory approval is just the beginning of your journey to market success!

One of the greatest misconceptions in the world of MedTech is the singular focus on regulatory approval. While crucial, it’s merely the starting line, not the finish. Let’s debunk some common myths together:

💡 **510(k) Shortcut? Not Always!**
While the 510(k) route may seem like the easiest and cheapest path, especially for “me too” devices, remember, convincing end-users to switch requires evidence. Medical providers are understandably hesitant to change when they already have functioning solutions.

💡 **Breakthrough Designation: Not a Magic Bullet!**
Attaining Breakthrough Designation isn’t a guaranteed shortcut either. Truly novel devices may lack existing reimbursement codes, necessitating clinical data for gaining reimbursement status. Quick doesn’t always mean easy.

💡 **Exit Strategy Fallacy!**
Thinking only about positioning for an exit overlooks the crucial aspect of long-term viability. Investors and Strategics seek devices with the highest potential for commercial success. Market access alone isn’t enough.

This tunnel vision has led many promising companies to fall short of their goals.

Identify and follow the regulatory path that aligns best with your company’s goals (not your predicate). Embrace clinical studies; they’re not as daunting as they seem! Craft a commercial plan that’s proactive, far-sighted, and tailored specifically to your product.

🚀Let’s reshape the narrative and shift to comprehensive success. 🚀

Lesson I Learned About Clinical Research


“I don’t trust people who have never failed at something.”

That’s what my friend said yesterday, and I agree! With that, I’d like to share another lesson learned from my repertoire of how I became a clinical research expert…

The study initially recruited 10 sites, with 2 expected to be leading sites due to their larger patient pool and faster enrollment capabilities. However, after a few months, the leading sites significantly underperformed.

I couldn’t figure out how could this happen there. I conducted a root-cause analysis and discovered that the sites were in a predominantly Spanish-speaking area, and the informed consent forms were only available in English. This language barrier hindered patient comfort, despite some site coordinators being bilingual.

  • Had to hire a translation service to produce new ICFs in Spanish
  • Lost a few months of the study timeline, missed out on great patients
  • Unexpected increase to budget
  • Had to amend the protocol, obtain additional IRB approval (which incurred more time and money)
Lessons Learned:

Selecting investigators and sites demands thorough diligence and strategic planning. Always factor in external considerations when assessing study sites.

The foundation of any study is its patients. Construct your clinical study with a patient-centric approach, or there won’t be a study.

Successful clinical research is relational and not transactional.

I wouldn’t have known this had I not experienced it.