08 Oct 10 Years – 10 Biggest Mistakes – Part 4
In tribute to our 10 year anniversary and our 100th client, we’re posting our top 10 best and most colorful screw ups. The entire list of 10 mistakes is a bit long, so we broke it into four postings. This is the fourth part of this short series.
Regional products – More and more companies are being drawn to the large, nascent medical markets overseas, in China and India in particular. If you’re also feeling an attraction to these areas, remember that your current product may not suffice, even if it has been successful in the US and Europe. And we’re not talking about the expected things like software or labeling issues.
Your product was most likely designed to meet specific stakeholder needs for the regions in which it was developed, including the user interface design, product cost and even the per-use cost. Chances are good that what worked in one region will not work in some of the big overseas markets noted above.
The U.S., in particular, has distinctively different buyers and/or users of technology-based products than China or India or other developing countries. Don’t be surprised if you end up having to significantly re-design the product for some of these overseas markets to better fit the needs of the local region. Your cost model may have to change completely, and may not work at all. Plan for this…don’t get blindsided. You may even want to find a local product developer in each distinctly different region that can provide input for the design.
Reimbursement – Reimbursement is central to the business plan of a majority of medical products. We have been surprised to find that this topic is not better researched by some of our clients.
We’ve seen more than once where the reimbursement research was delayed, purposefully or not, until some later point in the development program. We’ve seen cases where an expected or planned reimbursement model didn’t work or where existing reimbursement codes were wrong or didn’t apply. We’ve even seen cases where there were no applicable reimbursement codes.
Reimbursement can have a big impact on per unit and disposable cost targets, as well as the upfront development NRE. Give this the attention it deserves. Proceeding without understanding the reimbursement model adds significant business risk.
I hope you found something of interest in the above… and even something that may help you one day with your future development projects. That’s it for this four-part series, but you may see more of these lessons in the future. Don’t be afraid to make mistakes, just don’t repeat them.
- Covid-19 Update- Key Tech Designs New Positive Pressure Air Respirator - May 1, 2020
- Rubbing Elbows with FDA Medical Device Chief Jeff Shuren - October 29, 2015
- 15 Years! - March 4, 2013