There’s a new program at the US Food and Drug Administration. One designed to afford innovative devices a speedier review process. This Innovation Pathway 2.0 program is designed for pre-market evaluations of medical devices, expediting the process without reducing the need or quality of safety and effectiveness reviews. And some 30 years ago, there was a similar process for smaller companies- it worked, then, too. (I know, we used it- twice!) Continue reading Dialysis is the FDA hotbed, once again
We know that manufacturing jobs are being exported. But, now the R&D is being exported, too. Not only because the US is not producing fantastic scientific and engineering talent, but to afford corporations the ability to tailor their products to the overseas markets…plus, this curries favor with foreign governments by opening R&D centers in their lands. The US National Science Board (part of the National Science Foundation) reportedthat US multinationals have grown their R&D employment tallies overseas- with 85% of all new jobs being located outside the US. Right now, the total employment in US R&D activities is 73% of the total overall (down from 84% in 2004). Before you jump up and down, consider this fact- more than ½ of the engineering degrees being awarded are from Asia (56% in 2008) and only 4% graduate from the US- and that does not include the fact that more than ½ the PhD degrees granted in the US are awarded to foreign students (57%).
I get very annoyed when folks keep saying that we are in the post-industrial age. I consider that the industrial period has changed- as I have written here, agreeing with Dr. Neal Spence that we are in the third century of the industrial era. And, the news of late has shown this to be true- America is getting back to work again, due to its large manufacturing sector; still the largest one in the world.
We need to innovate! Are you tired of hearing that? I am- not because the sentiment is wrong, but because those saying it often have not a clue as to what to do- or, in many cases, what is innovation. I discussed this, as have many others. (Innovation needs innovators, Go and Create, Innovation is the key, among others of my posts that cover this topic. Use the search feature on the right of my blog, looking for ‘innovat’ and you will find many more.)
We keep hearing from our government that America has be innovative; we need to create new things. Innovation is, indeed, a vital component of economic progress. It is the driver for growth, for more competitive offerings among companies and countries, and a means for the creator (more typically, the creator’s company) to prosper. The problem is you really can’t engineer innovation. The most you can do is to increase the odds of it occurring.
We need to innovate to grow our companies. And, as I have always believed and averred, businesses, governments, and non-profits need to be creative and innovate on a regular, almost continuous, basis. It’s what I have tried to do when I have been a division head, a “skunks works” leader, or CEO/COO of an enterprise.But, not all companies (or governments or non-profits, to be sure) understand this. One of my first employments involved a “discussion” of the assignment of patents to my employer. I refused to agree to provide a blanket patent assignment to the company. The CEO felt I was being unreasonable. When I asked him how many products (patents) he expected from his good technologists, his reply was 1 to 2 every few years. (Trust me, that number was probably higher than his expectation, but I did not argue with the number.) My position was if I were to develop one new product a year- that should be the company’s. But, any developments beyond that should involve special compensation to me. And, the company would get to choose which one it wanted each year. He eventually agreed (only after there were multiple products in the pipeline and no patent assignation on file from me)- and we parted company soon, thereafter.