Introduction
Innovation is the lifeblood of progress and growth in any field, and academia is no exception. Universities and research institutions are constantly pushing the boundaries of what is possible and developing new technologies, theories, and methods. However, despite the abundance of innovation in academia, many of these ideas never see the light of day outside the lab. In this blog post, we will explore the reasons why this happens, and discuss the data that highlights the extent of this problem.
- High risk and expense of creating an marketable product:
Clear understanding of clinical need, market potential, and technical risks is crucial for scientific and technical innovation in the medical device industry. This involves comprehensive technology and science management, clinical trials, thorough testing, and regulatory oversight. Defining technical feasibility without prior knowledge of functionality or early test data can result in high costs and long time to market, so the medical industry should aim to minimize these risks and reduce costs and time to market by addressing feasibility concerns early in development, ideally before significant investment.
- Investors and Funding
One of the main reasons why innovations die in academia is a lack of funding and resources. Many universities and research institutions are underfunded, and researchers often have to rely on grants and other forms of external funding to support their work. However, these grants are often difficult to come by, and researchers may not have the resources they need to develop their ideas to the point where they can be commercialized. Additionally finding an investor might be challenging, investors may be cautious about advancements in technology. Medical professionals may have already invested in competing technologies. Investors may be unaware of the disruptive nature and safety, low cost, and non-invasive benefits of new technology. Some investors may also have reservations about the process of bringing medical technology to market.
- Gap between Academic Researchers and Businesses
Many new products fail due to a lack of understanding of real user needs. Many prototypes never make it to market because they fail to consider clinical and patient requirements. It’s very important to work towards changing the culture of commercializing medical devices/technology among academic researchers and improving communication between students, clinicians, product engineers, and scientists as a solution to this issue. Another reason why innovations die in academia is a lack of understanding of the market. Many researchers are focused on advancing their field of study, and may not have the expertise or experience to understand how their ideas could be applied in the real world. This can make it difficult to find partners or investors who can help turn their ideas into viable products or services. The data also shows that the commercialization rate of academic research is quite low. According to a study by the National Science Board, only a small fraction of the research produced by universities and other research institutions is ever commercialized. The study found that only about 10% of all research conducted in the United States is eventually commercialized. Another data from a study by Elsevier, which analyzed the patent data of more than 400 universities and research institutions worldwide, found that only about 2% of all patents filed by these institutions are eventually commercialized.
- Knowledge of Regulatory affairs and FDA
Obtaining FDA approval for a new medical device can be a lengthy and costly process. Many medical device companies believe the FDA needs to expedite the process to prevent foreign competitors from getting their innovations to market first. This can result in U.S. patients seeking cutting-edge treatments abroad that are not offered domestically. However, the FDA’s approval process is also criticized for various shortcomings that could put patients at risk from using defective devices. Under the Medical Device Amendments of 1976, the FDA classifies all medical devices as Class I, II, or III, with Class III representing the most potentially harmful devices such as implantables. A Pre-Market Approval (PMA) application for an innovative device requires a clinical trial or similar study. A PMA notification for a new device that is similar to one already on the market does not require detailed scientific information on effectiveness and safety. Considering the academics space, researchers and academicians lack the extensive knowledge of regulatory affairs thus get stuck in carving the regulatory approvals pathways for their innovative product.
- Clinical Trials
The FDA mandates clinical trials before a new product can enter the market. These trials, also known as clinical studies, assess potential treatments such as drugs, medical devices, or biologics (e.g. vaccines, gene therapy, blood products) on human volunteers to determine their safety and efficacy. Before human testing, the treatments undergo toxicity testing on laboratory animals. Clinical trials follow a protocol to answer specific research questions and can compare the new product to existing treatments or no treatment. Healthcare professionals closely monitor and evaluate trial participants in medical facilities or research centers. Clinical trials can cost approximately $12 million and require rigorous quality and effectiveness evaluations. To gain approval, innovators must demonstrate the clinical significance of their product through published research and trial results.
Introducing a new medical device or drug is a complex and expensive process that requires thorough testing and clinical trials before receiving FDA approval. To prepare for commercialization, products must undergo stability tests, design and process validation, safety assessments, and regulatory clearance. By familiarizing themselves with FDA policies, procedures, and requirements through Pre-Sub FDA submission, scientists and innovators can streamline the approval process. Conlis Global Inc. aims to simplify this process by leveraging their extensive team’s expertise in regulatory affairs, clinical trials, and translational medicine, among others.
Sources:
https://koreascience.kr/article/JAKO201717447648339.pdf
https://link.springer.com/chapter/10.1007/978-3-030-78893-3_8