Tag: MedTech

Organ on a Chip – The Future of Drug Testing and Development

Organ chip technology is transforming modern research because it mimics personalized organ systems and will serve as an alternative to animal testing and other testing methods. The organ on a chip is the size of a coin, clear and flexible with a two-channel microfluidic chip separated by a cell-permeable membrane. The microfluidic chips mimic organ functions or states in the body. The cell-permeable membrane is thin and can be stretched by a vacuum to allow for cellular communication between microfluidic chips. A tissue-specific support layer covers the cell-permeable membrane to aid in tissue growth and maturation. Organ chips are grown in a small device that controls chip movement so it can properly demonstrate the functions of the body. 

The first organ on a chip was developed in the 2000s. It was designed to model excess fluid accumulation in diseased lungs. The organ chip mimicked the airways in the lungs and even made a similar “crackle” noise, a symptom in patients with diseased lungs. Following the development of the lung chip in 2010, fifteen more chips were developed after other organs and systems in the body and can even mimic diseases and genetic disorders in the body. Beyond human systems, organ chips have been developed to model dogs, rats, and mice

As opposed to traditional animal testing methods, organ on a chip provides information about a drug’s effect specifically on human cells. Organ on a chip technology is intended to accurately represent the body’s organs and functions on a small, simple to use device to support a faster way to test the impact of drugs and their doses on the body. The technology is capable of determining whether new drugs are safe by discovering early warning signs which helps researchers accurately understand disease effects on the body. This information and technological ability can lead to tailored treatments for individuals by providing researchers information on how specific people will respond to a drug. A “Patient-on-a-Chip” program is being developed to provide patients with tailored treatments to make care safer and more effective. Scientists collect blood or skin cell samples that are converted into special stem cells and then created into organ cells containing the person’s genetics. Scientists can test drugs on the organ chips and see how the specific person would respond before the person takes the medicine.

Since this is a novel technology, regulatory agencies can be less likely to accept the data from an organ chip and may require additional information to confirm the accuracy of the findings. However, the Food and Drug Administration (FDA) has conveyed interest in organ chips through working with pharmaceutical industries to help further develop the technology. In April 2025, FDA announced that the administration would be phasing out animal testing in replacement of human based models, such as organ chips. To implement this change, FDA will be updating policy and regulations to allow for new methods during drug testing. In doing so,  FDA expects that this will accelerate drug testing and reveal human-specific side effects that may not be revealed during animal studies. The Human Liver-Chip was recently accepted into FDA’s Innovative Science and Technology for Advancing New Drugs pilot program, which allows for the use of drug development tools that do not meet regulatory standards but provide supportive data. This program is intended to aid in the acceptance of new drug development tools

NASA has also expressed interest in the technology and plans to send organ chips to the Moon to study effects of gravity and space radiation. Microgravity from space travel can make the human body age at an accelerated rate. Researchers developed a program called Tissue Chips in Space 2.0 that sends organ chips to the International Space Station with the goal of studying the effects of microgravity to understand how diseases develop, test treatments, and improve astronaut health during space travel. 

M&A Momentum in the Medical Device Industry


From EpiPen smartphone cases to portable kidney dialysis, the MedTech industry revolutionizes access to life saving care for patients. Robust market innovation has improved personalized treatments, reduced time in hospitals, and lowered healthcare costs. In the past year, high value investments and acquisitions have gained significant traction as businesses seek to leverage their portfolios to generate new solutions for healthcare providers. Over 305 acquisitions were announced in 2024, exceeding $63 billion, according to JPMorgan figures. In light of regulatory challenges and complex mega-deals, M&A legal teams have taken a leading role in facilitating these high stakes transactions, counseling clients across borders and fostering vital alliances. The strategic consolidation of smaller innovators with well-established MedTech companies catalyzes a swifter deployment and integration of new devices into health systems around the world. This article investigates driving forces behind the industry’s M&A surge and future implications across the health law landscape.

External innovation has long played a crucial role in market capitalization for leading MedTech companies, such as Johnson & Johnson, Medtronic, Stryker, Abbott Laboratories, and Boston Scientific. Although multi-billion dollar deals draw more public attention, smaller strategic opportunities have become an attractive avenue for garnering strong returns by harnessing the novel creativity of breakthrough start-ups. Specialized technologies that impact essential clinical areas, such as cardiovascular health, stroke prevention, and advanced screening and diagnostics, have grown through recent advancements in AI. In an industry hungry for innovation, competitive designs specifically related to preventative medicine and remote monitoring have become high-demand targets of M&A activity. These deals tend to offer a more cost effective method for portfolio growth and maintaining a competitive advantage, rather than developing products in-house. Law firms across the globe diligently guide corporations in navigating intricate regulatory, commercial, and ethical challenges to help bring cutting-edge products to the market.

Along with recent scientific progress, economic and political factors contribute to the rise in MedTech transactions and venture investments, such as declining interest rates and industry deregulation. From advising on intellectual property protections to litigating industry-wide resolutions, M&A lawyers assume a significant role in the oversight of successful MedTech deals. In response to modern technology, legislators continuously adjust regulations on both national and state-specific levels, requiring practitioners to adapt to ongoing changes across the industry. For example, many digital products in medicine present future challenges for safeguarding patient privacy and ensuring consumer transparency, placing a greater emphasis on compliance for market expansion in the field. In order to make products accessible in the global market, corporations must secure various approvals, often requiring the regulatory expertise and risk-averse strategies of legal counsel. Specialized knowledge about data privacy, structured finance, and market dynamics are a key backdrop of MedTech dealmaking, with the goal of delivering and implementing life changing health care devices.

With a variety of unique ideas and actors populating across the medical device industry, new and exciting products are on the horizon. Many have already accumulated data and evidence reflecting success but await FDA approval for public distribution. Because of extensive relations between physicians and medical device companies, incremental modifications are made in the research and development process to maximize potential. The emergence of “wearable” health technologies, such as electrocardiograms, glucose monitors, and AI-powered robotic prostheses, offer numerous benefits to patients by adapting to the body using real-time data and trends. Smartwatches that detect irregular heart rhythms offer a vital form of self-monitoring, as heart disease remains the leading cause of death worldwide. Certain types of paralysis and blindness, previously incurable diagnoses, are now targeted with neural implants, altering the future of regenerative medicine and stimulating cell growth. By facilitating deals between promising tech firms and far-reaching device companies, M&A has expedited patient access to remarkable tools and encouraged a competitive edge in pushing innovative boundaries.