When crafting a budget for your medical device development and launch, it is important to know the primary sources of money drain:
Testing – especially biocompatibility, large animal and clinical studies
Regulatory, quality, product and clinical documentation
Regulatory application review fees – especially a PMA
For the cost of testing one can select labs that offer quality, credibility and great pricing. Elexes has helped many companies identify such labs.
One can optimize the efforts on documentation by ensuring the strategy is thorough and supported by objective information. Numerous companies have saved a lot of time and money following the right steps, the first time itself. Work with an experienced partner who has “been there done that”, and it is true that more expensive is not always better. Look for someone who will not only advise but also do the paperwork.
For regulatory applications, check if you can qualify as a small business – Table below, striking differences between the fees of a regular business vs. small business.