It can be said with a fair amount of assertion that the healthcare industry is the most dynamic. The outbreak of the pandemic presented a huge impetus for the swifter adoption of digital technologies. This was primarily towards the objective of observance of social distancing in the efforts to contain the virus. From remote care to research and development (R&D) initiatives of drug development and discovery, monitoring and evaluating standards of therapeutic care, and manufacturing medical devices, digitization is truly transforming healthcare in the truest sense of the term.
The sheer speed at which innovations are happening in medical devices manufacturing is one to be reckoned with. Manufacturers are cozying up to additive manufacturing (AM) to optimize the design of medical implants and instruments. This is essentially transforming entire manufacturing workflows through the end-to-end overhaul of legacy elements, the replacement of which is fulfilled using new-age tools and technologies, software applications, and smart services. This, in effect, bears business benefits in the form of reduced manual efforts, a lesser number of processing mandates, an overall reduction in the cost of manufacturing.
Scaling Potential, Navigating for Growth
Let us delve deeper into the mapping of these disruptions and the potential gains that the medical devices industry seeks to gain from the adoption of digitization:
• Upgrade Process Capacity:
Complexities in shop floor management arising out of the production of small batches, mixed orders, and rising demands of medical devices are necessitating manufacturers to embrace Industry 4.0. Equipped with the right automation tools, they can solve these complexities while simultaneously increasing production capacity and operational efficiency. At the core of Industry 4.0 lies the adoption of a new-age manufacturing execution system (MES), a monitoring and evaluation process that can help manufacturers address quality issues and regulatory compliances.
On the flip side of Industry 4.0 is the implementation of Quality 4.0, which essentially entails using smart tools to complement legacy systems across the value chain, viz. the seamless integration of MES, enterprise resource planning (ERP), and product lifecycle management (PLM).
As a corollary to Industry 4.0 and Quality 4.0, medical device manufacturers can analyze operational data, proactively manage risks, and pre-empt quality issues by analyzing real-time
data across the value chain in a unified manner.
• Reduce Costs: Price competition puts medical technology manufacturers under extreme pressure. Patients, governments, and healthcare providers’ demand for lower prices put them under further duress. In this era of value-consciousness, consumers are mostly aware of where they can get the best deal. Even though they are willing to pay higher for premium products and services, whenever a purchase isn’t urgent, they are more likely to bypass the same if they are on a budget constraint. In the face of this reality, medical device manufacturers can save their business only to the extent that they gravitate towards a system of “lights-out” factories. Minimized human interaction and automation can help reduce costs to a minimum. Automated molding is financially sensible for a large production volume over a longer period.
• Increased Agility and Improved Product Quality: Medical device manufacturing has come a long way since the United States Food and Drug Administration (FDA) approved Mazor SpineAssist in 2004, the first robot to guide the placements of pedicle screws. Following this breakthrough, the market has developed leaps and bounds. Several companies have developed their versions of spine robots, and several more are yet to come. Healthcare practitioners have lauded robots in surgical ecosystems for their ability to limit radiation exposure, their improved precision, which as a matter of consequence, translates into swifter patient recoveries and better surgical outcomes.
• Adhering to Extremely Stringent Global Regulatory Compliances: In early May 2017, the European Union (EU) imposed new marketing standards for pharmaceutical companies seeking to market products within their territory via the Medical Devices Regulation (MDR). In May 2021, they further strengthened this regulation when the same was enforced for Class III devices. In a world of extremely stringent regulatory compliances, medical device manufacturers must find out a solution to adhere to the same while navigating their way through elevated adherence costs.
The answer to this complexity is a solution that consolidates enterprise-wide regulatory requirements into a uniform process that systematically tracks whether the norms are being adhered to. This must be supplemented with seamless integration with the existing PLM processes. Stakeholders at the helm of managing such a solution would regularly receive updates on finished goods. Upon receiving these updates, they can fast-track the documentation based on pre-configured templates embedded within the solution.
• Harnessing Potential for Service Differentiation: Since medical device manufacturers face cost-conscious and value-oriented customers, they need to adapt their businesses accordingly. To make the most of this situation, they need to thoroughly understand its value segments, needs, and potential profit pools. The idea behind service differentiation is not always changing existing products or offering new ones but using innovative sales models for existing offerings. It is in the hands of pharmaceutical companies to determine their best option and create a business model in line with the same that helps them thrive in the value segment.
Role of AI in Medical Device Manufacturing
An early 2021 study by The Lancet found that 222 artificial intelligence (AI) and machine learning (ML)-based medical devices were approved by the FDA for use in the United States. It also reported that 240 such devices were approved for use within Europe. Medical device manufacturers have realized that digitally mature manufacturing will help create smarter and agile facilities.
As we progress further, technology will only bring people and processes together towards seamless manufacturing units that provide beneficial outcomes to communities. It will essentially help to better products through intelligently understanding the real needs of customers. A tech-enabled medical device manufacturing with an “intelligent layer” will set the tone of creating self-sufficient and empowered communities.