Working for the Industry

During the spring semester 2008, I was working as an intern for the World Heart Inc, a company that designs and manufactures Left Ventricle Assists Devices or LVADs, a device that is used to partially or completely replace the function of a failing heart. I found the experience very instructive, rewarding and enjoyable altogether, although sometimes replete with moments of frustration and confusion. Despite the fact that it might be hard to assign a title to my job, since I was novice in doing my main task and also since interns are usually asked to do different temporary and transient tasks, I was mainly working as a marketing researcher. My main task was to study a certain product of one of our competitors and conclude whether it would be to the benefit of World Heart to get involved in producing a similar product or not. I found a number of aspects of working in the bioengineering industry in a high-tech company such as World Heart very interesting, something that I would have never imagined to be the way it actually was. Probably the first piece of the industry that I was introduced to was the comparison and competition factor that exists among the companies. In fact the main task that I was asked to accomplish clearly depicted this aspect of the industry. In the very first day of my job at World Heart, my boss, Mr. Pratap Khanwilkar, The VP of marketing and business development, explained to me the devices and products that the company has already manufactured or is still working on so as to get it out on the market. Next came a general description of a product named Centrimag from Levitronix Company, one of the competitors. He mentioned that my long term goal in this company is to study that product, understand its strong points and also shortcomings, study its clinical data, do research on its market size and ultimately issue my verdict as to whether working on a similar product was one that should be on the companys agenda. It was very interesting for me to see that by examining the results of the clinical trials of 1

a product by another company, the market that is out there for the product and by studying the revenue and profit that the product brings in for that company, our company can make important decisions for its future course of action. In fact a number of tasks that I was asked to complete on a sporadic basis, also encompassed the same principles and methods. For example by comparing the clinical results and market information of a number of products from companies such as Thoratec, Berlin heart, Ventracore, etc. that resembled the World Hearts Levacor VAD a magnetically levitated bearingless pump Mr.Khanwilkar was able to convince the venture capitalists to invest in the company by showing the increasing number of hospitals, doctors and patients who are using these product (the growing market) and ultimately provide funding for the company to survive. As I mentioned earlier, the result of such studies can also be used to determine the direction to which the company is going as well. Another Interesting, yet annoying fact about industry is the existence of politics. It was very interesting to see how connections and who you know can affect the performance of a company. In fact at the very top of the companies, the BOD or the Board of Directors who supervise all the activities of the company, also in a way serve as a means for networking. Moreover I learned that even conferences and showcases serve that purpose as well. However, by that I do not mean that networking is the only purpose of conferences or exhibitions. As an example, in the process of seeking funding for the company, networking plays a crucial role. Whether the proposal for a grant is being processed by a creditable institution such as NIH or NSF or simply by venture capitalist, personal relations can greatly affect the decisions made: the better you know the members of the NIH, NSF or the VCs and the better your relationship is with them, the higher your chances of receiving the funding necessary.

The importance of networking is not only limited to the area of finding necessary funding. Even when it comes to legal issues, such as patenting a product, again networking can play a vital role. A question that had always baffled me was that how it is possible for a company to start manufacturing a product that is similar to a product from another company, without waiting a full 17-year period for the patent of that original product to expire. I learned the networking, along with smart engineering that can make slight changes to an already patented product, is the answer to my question. Personally I find the existence of such politics in the industry very annoying. However I have learned that industry is not alone in that respect. Even academia is not free from that kind of networking, whether for funding or other purposes. Another aspect of working in the industry that was very new to me was dealing with uncountable regulatory rules and policies. Due to the fact that I had to study clinical results of different products, I started learning about some FDA regulations involved. It was very interesting to see how FDA strictly monitors and supervises the process of clearing a device until it is marketed. I learned about how FDA classifies a device into one of 16 medical specialties referred to as panels and 3 different classes. Studying about different phases of clinical trials (phase 0 (pilot studies) to phase 3) that a product goes through was of great interest to me. Even after a product is released and is available on the market FDA still monitors its performance or the way it is being marketed. I learned that being sued for off-label marketing is the nightmare for any company that can even bring the company to a halt due to FDA harsh punitive actions in that regard. Above all the features of the industry that I found worthy of attention and even praise is the fact that in industry feasibility and marketability of an idea is of great importance. Contrary to the academia that pure knowledge is the main incentive that drives the research process, where ideas might be of no actual use, or at least not readily usable, industry is driven by the aspiration to find methods and devices applicable to everyday life. Although on the surface one 3

might claim that all that companies are seeking is profit, and that this is not ethically desirable, one should not lose sight of the fact that having a usable product on the market can save lives of thousands and thousands of patients and add comfort and quality to their lives, besides the profit for the company. In order to be fair it should be mentioned that even in academia the purpose is not always solely pure knowledge. A lot of times researchers and professors try to publish papers on their research so as to increase their credibility and their Impact Factor, therefore even academia could be a place full of selfishness. It seems to me that the teamwork necessary in the industry environment and the ability to have a vision of what is needed for the society and resultantly for the company to work on, are among greatest lessons one can learn from working in the industry. In conclusion, I found my experience with World Heart a very pleasant and memorable one. I learned skills that I had never even thought about. Working on a project like what I did in WH, the results of which can determine a direction of a company, was full of exciting, instructive and also frustrating moments. Teamwork and the ability to predict the future needs of the society, and having a vision as to what the next step should be, were some of the lessons I learned during my experience in this industry.