The Boston Scientific Corporation announced recently that it has entered into an agreement with the Synergy Innovation Co. to purchase the latter’s majority stake (which is estimated to be around 64% of the publicly traded Korean company M.I.Tech. M.I.Tech is a medical device company which manufactures and distributes equipment for urologic and endoscopic procedures. The aforementioned agreement comprises a purchase price of KRW 14,500 per share. As a total, this represents KRW 291.2Bn, which, in dollars, set at current exchange rates, would be roughly $230m, which would be subject to closing adjustments. M.I.Tech is responsible for the creation of HANAROSTENT tech, which is a collection of conformable metal stents, which are self-expanding and non-vascular, and they have been in distribution through Boston Scientific in Japan for the last 7 years. These stents, which are designed for non-vascular gastrointestinal and airway use, aid in the clearing of occlusions and strictures around various area’s of the patient’s body. The pancreatic duct and biliary tree are two such examples, as well as the colon, duodenum and oesophagus. In the majority of cases, stent placement can be minimally invasive, possibly aiding in a faster recover for the patient than surgery. The technology of the HANAROSTENT features a design with a unique hook-cross nitinol structure, with the intent of providing a flexible and natural fit within the anatomy of the patient. It also features flared ends to aid in preventing stent migration. "M.I.Tech is an innovator in non-vascular stent development, with product offerings that complement our existing stent portfolio, including the differentiated AXIOS™ Stent and Electrocautery Enhanced Delivery System and the flexible and conformable Agile™ Esophageal Stent System," said Art Butcher, executive vice president and group president, MedSurg and Asia Pacific, Boston Scientific. "We are committed to investing in technologies that advance care for patients around the world and are eager to work more closely with M.I.Tech to expand their international footprint." The transaction is expected to be completed during the 2nd half of 2022, but is subject to the customary closing conditions. The impact to GAAP (Generally Accepted Accounting Principles), as well as adjusted earnings per share, is anticipated to be irrelevant in 2022.

One of the global leaders in healthcare technology, Medtronic PLC, has recently received FDA (the US Food and Drug Administration) approval, as well as Breakthrough Device designation regarding its LigaPASS 2.0 tech. The latter is a Ligament Augmentation System, and it is the 1st and so far only FDA-cleared device with is designed for ligament augmentation within the field of spinal surgery. Ligament augmentation has been the subject of study for use on PKJ proximal junctional kyphosis), which is a common post-op complication of spinal deformity surgery in adults. Though the precise cause in unknown, PJK is assumed to involve the disruption of of spinal ligaments, and can likely affect up to 46% of all patients. It is a condition which can significantly impact the patient’s quality of life, and while its severity can differ from subject to subject, there is a risk that it can mutate into a more severe form, know as PJF (proximal junctional failure). Patients who develop this may end up suffering from neurological and structural complications, leading to the need for further surgery. “The surgical treatment of adult spinal deformity provides significant clinical benefit to patients but unfortunately many require revision due to early mechanical failure. The most common cause of mechanical failure is proximal junctional kyphosis,” said Christopher Ames, M.D., Director of Spinal Tumor and Spinal DeformitySurgery at UCSF Medical Center in California. “Failure reduction strategies, such as ligament augmentation, are likely to become critical techniques in the treatment of this challenging patient population. In my practice, LigaPASS™ 2.0 helps me meet my goals to reduce revision surgeries with these patients.” It is also possible to pair the LigaPASS 2.0 system with the UNID ASI (Adaptive Spine Intelligence) platform. UNID’s ASI is improving the standard of care of patient specific spinal surgery by utilising data science and AI aid surgeons in the planning, analysis and execution of their procedures. “This clearance and Breakthrough Device designation demonstrates our ongoing commitment to innovation in spine surgery and delivering industry-leading solutions that improve care for patients and improve the experience for surgeons,” said Dan Wolf, Vice President and General Manager, Intelligent Data Solutions at Medtronic. The ligament augmentation technique made possible by LigaPASS offers surgeons the possibility of stabilising between collapsed vertebrae in adult patients with spinal deformities who require constructs which may extend as far as the pelvis. This new procedure is built with the aim of compensating for muscle collapse during open posterior surgery, as well as aiming to decrease junctional stress.

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."