ISMR March 2022 | Page 29

INDUSTRY REPORT continues unabated in most countries , the industry is still struggling to make informed decisions about the supply chain , general markets , products and regulatory duties .

“ The pressure to reduce medical device prices is another key concern . Before launching a product in the market , numerous costs ( such as rent , expenses on labour and materials , etc .) are incurred , which must be considered by manufacturers . All these costs determine the overall price of the device ,” explained Nagarro .
“ Cybersecurity risk remains a major concern for the industry . Digitalisation technologies , such as AI and robotics , have overhauled the healthcare industry . However , these technological innovations have also paved the way for cyber threats . Hackers can gain access to medical devices and tamper with them through a security breach .”
As consumer requirements are changing continuously , it also recommended that traditional MedTech companies rethink enhancing the customer experience . The growing interest of technology giants in medical devices may also hamper the market share of existing players . Many start-ups are imposing continuous innovation pressure on medtech giants .
The medical device business model is also transforming with digital disruption . This change is driving massive investments in medical devices across the spectrum , whether as an accessory , software as a medical device ( SaMD ) or while connecting to other devices in a specific ecosystem etc .
Metals in healthcare
Metal , rather than plastic or other material , is generally chosen for applications that require the highest degree of strength and durability , especially when used for tools or as replacement joints which are subject to a lot of mechanical stress .
Aside from purely mechanical performance , metals used in a healthcare environment must meet specific criteria that most other products do not . For example , they may need to be non-toxic in the presence of human tissue or fluids . Or , they might have to resist chemicals such as detergents and alcohols which are used for cleaning . Metals used for implants must be non-magnetic and non-corrosive , in addition to being non-toxic .
Metals used in global medical markets include titanium ; stainless steel ; platinum ; tantalum ; cobalt / chrome and Nitinol . Platinum ' s biocompatibility makes it suitable for temporary and permanent implantation in the body , a quality which is exploited in a variety of treatments . Although rarely used in medical implants , copper has outstanding antiviral and antibacterial properties and is suitable for surfaces that are constantly being touched ( such as door handles , bed rails and switches ).
“ While seldom used in direct contact with the body , aluminium is very commonly employed for various types of support equipment that must be light , strong and corrosion-resistant . Examples include bed frames , wheelchairs , walking sticks , orthopaedic supports and IV stands . Since raw aluminium can tarnish or oxidise very easily , aluminium parts are typically painted or anodized for durability ,” commented medical manufacturing specialist , Star Rapid .
However , while titanium ’ s near-term opportunities in the medical field are lucrative , several experts have offered words of caution regarding downward cost pressures and challenges to the global supply chain for medical devices . The expectation appears to be for steady , incremental improvements in metal grades that offer enhanced strength , wear resistance and properties that encourage bone to fuse to titanium — a process called osseointegration .
Orthopaedic applications , especially hip and knee replacements , continue to drive medical market applications for metals . Trauma applications , such as bone plates and screws , and spinal components , represent two other major sales areas for the medical market .
Examples of application areas include surgical instrumentation ( arthroscopic ; ophthalmology ; endo-laparoscopic and electrosurgical ) and
Stampings for the medical industry . electro-medical implants ( such as pacemakers ; defibrillators ; hearing assistance devices and heart pumps ) as well as interventional stents ( angioplasty ; catheter ablation and distal protection ) and orthopaedics ( spinal fixation ; hip implants and knee implants ).
The requirements for materials , production quality and process documentation are high , making for a demanding environment for production technology and process planning . To enter the marketplace , medical devices must comply with pre-defined product lifecycle parameters intended to maximise patient safety and ensure the highest quality standards . n
Orthopaedic applications , especially hip and knee replacements , continue to drive medical market applications for metals
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