In 2021, the regulatory affairs market for global medical devices had been valued at $7bn, however this is expected to reach as much as $12.2bn by 2031, increasing at a CAGR of 5.8% over this period. This government regulatory affair specialises in regulated industries. These can include agrochemicals, pharmaceuticals, and medical devices. Regulatory affairs have a very specific use within the healthcare industry. The regulatory function within the healthcare industry has proved critical in ensuring the ready availability of healthcare products around the world which are safe and effective. Professionals within regulatory affairs can include those who enforce regulatory compliance, as well as those working in the fields of quality assurance or clinical affairs. Regulatory affairs experts on medical devices act as a bridge between that industry and various global regulatory bodies, such as the USFDA, MHRA, CDSCO, PFSB, or the TGA. A new medical device can cost millions to produce, and any errors in development may have a significant influence on the company’s reputation. Because these medical devices play a deeply integral part in the lives of patients, and could aid in things like prevention or treatment of disease, or early diagnosis, it is crucial that the quality of the device is assured, which is the role of the regulatory device expert. They are also responsible for ensuring that all essential information about the device is accurately conveyed to the user, and any mistake, even if seemingly small, can lead to recalls, and potentially millions of wasted dollars. The expectation is that the market will witness moderate growth during the next 9 years. This is likely down to the inventions and developments of advanced medical devices, which can be used to treat various kinds of disease, including cancer, cardiovascular, and infectious ailments, along with improvements in technology across a broad spectrum of the healthcare sector. Also, a surge in the geriatric population, alongside various advances in technology to meet the needs of all patients, may well factor in. But there are also factors which it seems like will restrict market growth to some extent, such as the tall cost of being able to provide regulatory services, as well as an increase in cyber attacks on software-based medical devices. While these may have a slight impact, however, it will ultimately not stop the forecast for the increase of market value.

The world-renowned company Smith & Nephew is gong to be leaving its location in Hull after being based 160 years in the city. The company is set to relocate 8 miles (13km) away in Melton, on a new site costing £80m. Around 800 are employed by the medical device manufacturer, which has been based in the city of Hull since its foundation in 1856. City Labour MP Emma Hardy has expressed disappointment in the firm’s choice to relocate, though has said she understands the reasons behind the move. In a statement, she said: "Hull was the birthplace of Smith & Nephew. It's where the company started. It has all its history, it has all its heritage there on this site in Hull. But, I understand they wanted 23 acres and, of course, you can't find 23 acres within the boundary of Hull, it's simply not there. My focus right now is going to be making sure everyone keeps their jobs when they open this new site." Smith & Nephew have claimed the new facility in East Yorkshire will make a "world-class research and development, manufacturing and flexible office environment" which would "generate more than $10bn (£8bn) of sales in its first ten years of operation". The investment is in part supported by a grant from the government. The Minister for Innovation, Lord Kamall, said: "Smith & Nephew's new R&D base will ensure the UK remains at the forefront of life sciences and innovative research, levelling up the health of our nation, tackling disparities and saving lives." The historic company was founded by Thomas James Smith in 1856, beginning as a dispensing chemist, but developing into a global business. Mike Ross, leader of the Liberal Democrats on Hull City Council, said he had had meetings with bosses at Smith & Nephew, who "made clear there was not sufficient suitable land within the city boundary that could be made available at the pace their plans required". He added that while his preference would have been for the company to remain inside the city, he felt "optimistic [that] the new location – just a few minutes up the road – means our residents will be able to keep their jobs. Protecting jobs has been the council's priority and we will continue to work with the company and local MPs to ensure this is the case. The company has also committed to working with us to ensure its current site plays a key role in meeting the city's future employment needs, and this will be central to the redevelopment of the wider English Street area."

The US Food and Drug Administration (FDA) recently authorised the Labcorp Seasonal Respiratory Virus (acronym: RT-PCR DTC) Test for usage without a prescription by those with symptoms of a respiratory viral infection with a similar consistency to COVID-19. This is the first non-prescription straight-to-consumer multi-analyte Covid test which has been authorised by the FDA, and allows the individual to collect a nasal swab themselves from home, before sending the sample to Labcorp, so it can be tested. This test can identifya multitude of respiratory viruses simultaneously, detecting both Influenza A and Influenza B, more commonly known as the flu, along with respiratory syncytial virus, more ubiquitously known as RSV, and also SARS-CoV-2, which is the virus that acts as a catalyst to Covid-19. The results are then delivered via an online portal, as well as follow-up contact from a healthcare practician in the event of either positive or invalid results. “While the FDA has now authorized many COVID-19 tests without a prescription, this is the first test authorized for flu and RSV, along with COVID-19, where an individual can self-identify their need for a test, order it, collect their sample and send it to the lab for testing, without consulting a health care professional,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “The rapid advances being made in consumer access to diagnostic tests, including the ability to collect your sample at home for flu and RSV without a prescription, brings us one step closer to tests for these viruses that could be performed entirely at home.” The home sampling collection kit can be bought either online or in-store without having to provide a prescription. These samples are viable for self-collection by those aged 18 or older, or collected by those aged 14 and above with adult supervision. The kit is also available for use of those as young as 2, as long as it is collected and administered by an adult. All of this means consumers can determine more easily whether or not they may be infected with RSV, flu, or COVID, which in turn can allow them to determine whether or not quarantining in self-isolation is necessary. It also aids in assisting decisions following a discussion with a healthcare professional. The FDA is an agency contained within the US Department of Health and Human Services. It’s role is to protect the public by regulating the safety and security, as well as effectiveness, of drugs designed for human and veterinary consumption.

Leading musculoskeletal solutions company Globus Medical, Inc. today announced the world’s first surgeries performed using Excelsius3D, an advanced intraoperative three-in-one imaging platform, which is the latest addition to the Excelsius Ecosystem from Globus Medical. The first clinical cases using this technology were performed by Paul C McAfee and Mesfin A Lemma, and Jeffrey A Goldstein. Dr. Lemma has said that “the Excelsius Ecosystem can help us provide patients with minimally invasive treatment options. We are excited about the addition of the new Excelsius3D™ imaging system to our ExcelsiusGPS robotic navigation platform at MedStar Union Memorial Hospital.” Dr McAfee added: “With these two technologies, we are able to efficiently perform surgery with minimally invasive techniques. The seamless interface between the two platforms allows us to provide the best leading-edge technology to patients.” Dr. Kent, the founder of Axis Spine and a surgeon at Northwest Specialty Hospital, commented: “We are very proud to feature some of the most advanced surgical spine solutions in the nation. We have performed over 700 cases with ExcelsiusGPS and are now excited to add Excelsius3D to provide our patients with more efficient surgical solutions that have the potential to further improve surgical outcomes.” Dr. Goldstein, the Director of Education and the Director of the Spine Surgery Fellowship at NYU Langone Health, stated: “The addition of Excelsius3D™ to our operating room has helped to streamline our navigation workflow with ExcelsiusGPS®. The intraoperative imaging technology enables us to efficiently visualize anatomy, offers three imaging modes in a single comprehensive system, and is easy for our radiology technicians to maneuver and position. We’re excited about this new tool to help us provide patients with the best possible care.” Globus Medical has an innovative platform of enabling technologies, and Excelsius3D is the latest addition. Combined with the ExcelsiusGPS robot-navigated system, Excelsius3D provides an advanced intraoperative robotic solution which is image guided. It’s designed to further the accuracy of implant placement, as well as decrease exposure to radiation and shorten operation times, and is now available commercially in the US. The Excelsius3D mobile X-ray system can be used for for 2D digital radiography and 2D fluoroscopy, as well as 3D imaging for use with both adult and pediatric patients. The system is intended for use when a physician would benefit from such things as 2D and 3D information on anatomic structures or high contrast objects with a high level of x-ray attenuation (eg metallic objects, or bony anatomy). The images generated by Excelsius3D are also compatible with image-guided systems, for example ExcelsusGPS. The Globus Medical, Inc. company was founded in 2003. Its base of operations is in Audubon, PA.