My husband and daughter have been diligently working on her 8th grade science fair project the last few weeks. My husband special-ordered some components and has now made at least three trips to Radio Shack for other supplies. All told, this little project has run us nearly $350. That's significantly more than we intended to spend, but you hate to cut back on a science project that actually captures a teenager's attention. That's an outcome that's worth every penny you can give it.
The fact is, science takes a lot of money. Good science takes even more money. And science that is performed in a regulated environment... well, that can be quite expensive!
I've written a lot over the past year about the pros and cons of IVDMIA making it harder to get new tests on the market. Although I know there are some CLIA labs that have taken advantage of a less intense regulatory environment, I also know that most labs do very good science and are very concerned about putting only high-quality, well-validated products on the market. I am sympathetic that new regulations will soon require more expenditures to even make products available to physicians and patients.
I also recognize that these are challenging times to be an investor in IVDs. There are fewer ways for investors to see a return and time to market can be daunting. Added regulatory burden isn't going to make any of that easier.
The real question, though, is not whether good science costs more than you intend -- it almost certainly will. The real question is what you're getting for your trouble. Regulated science can be incredibly expensive, but it can also be quite lucrative. When the regulatory bar is raised and some products struggle to stay on the market, it is a competitive opportunity for those products that were taken the extra mile. A crisis for some will be an opportunity for others.
The added burden could also increase the long-term value of these products. In my experience, those companies that can meet the expectations of FDA and work through the inevitable challenges are rewarded by being able to make more substantial claims. When claims have passed FDA review, they may be prove more durable than those made under less stringent oversight.
Ideally, everyone does better in an environment where only the best products are used in patient care. Generally speaking, the best products cost more to produce.
Meanwhile, I think it may be time to start discussing some budget controls for our household science experiment. I love that my daughter is learning so much, but we should probably wait until high school to introduce her to potential investors.
