As a graduate student with some field experience, I am no stranger to receiving directives on what research needs to be completed to advance an employer’s agenda. The environment can be fast-paced and exciting, knowing this is a product close to reaching the market. However, as Dr. Simon noted, managers do in fact get in the way and cause drastic scope changes that could detrimentally affect progress.
From this week’s lecture, we’ve witnessed clear differences in how research is handled between industry and academia. Industry is ultimately driven by profit, even while aiming to improve customers’ lives through products and services. Academia, by contrast, focuses on answering unanswered questions and advancing knowledge. Resource allocation and usage are also major differentiators, but those have been discussed in other threads.
So, here are my questions: in either academia or industry (based on your own experience or expectations), what type of research would you want to pursue, and how would you go about expediting progress? What questions would you ask to guide your work? And in industry specifically, do you think it’s realistic to complete—or at least begin—your research within the expected timeframe?
I have some industry experience in a small laboratory setting. What I did to expedite the progress was online research because I did not have much knowledge on instrument chemistries and sterilization practices at the time. This meant using credible sites and publications to build a protocol. I also had team members to share ideas and concerns with. I used my resources in order to write a protocol that included the background, objectives, procedure, and analysis plan. What was important to me was to satisfy management requests, thus removing any unnecessary information. The question I had to ask myself was how I was going to accomplish the goal of the study with the limited equipment, supplies, and budget I had access to. Ultimately, I was able to complete the study on-site versus using a contract or academic lab by refining the protocol.
In the future, I would like to advance in industry and enter medical device development research. I would use similar strategies to progress however the plan would differ. The equipment and supplies needed for in-vivo or in-vitro studies would be more costly and harder to obtain which may push research by months. For this reason, I expect for research to not be completed in the expected timeframe because management approval is required and they consider these factors. Otherwise, a contract or academic lab may be the appropriate option. If the expected lifespan of the medical device is for a long duration then the research timeframe may vary depending on how well-known the material is. These challenges can extend both the planning and executing phases.
I have just started working in the biopharmaceutical industry, and one of the things they really hammer down is following protocol in order to stay within federal regulations. If we slip out of compliance, production can be stalled or even seized until issues are corrected. At the same time, management also encouraged us to speak up when we see safe ways to streamline a process. I think a similar approach should be applied to medical device development. Regulatory compliance can prevent huge delays or, depending on the research, weeks of repeating tests if protocol aren't followed properly. It's best to considered how the study should be structured to meet those standards first before considering how to make it more efficient. Does anyone think that putting too much priority on regulation can actually discourage innovation for faster or improved methods, or speeds up progress overall?
Starting research on time in industry is realistic, but fully completing research on time is less realistic. The deadlines in industry are often there to demonstrate that progress is being made to shareholders. Having shareholders that are happy with the progress on a project ensures that a project can keep going. Showing a lack of direct progress can quickly lead to unhappy shareholders. As mentioned, regulatory is a big challenge and can really derail a project's timeline. Products can get past all the hurdles associated with development, but might fail to pass regulatory. I believe that prioritizing regulatory in the early project planning stages can help speed up progress overall. Being prepared to encounter difficulties and have a plan in place to circumvent these issues can be beneficial towards a project. Early collaboration with individuals well-versed in regulatory and establishing strategies to manage risk associated with regulatory is key for project success. For industry, are short-term goals more important than long-term goals?
