Tommaso Borghi, design program manager at Flex Health Solutions, writes about how new, low-cost manufacturing methods can help make disposable drug delivery devices more available and affordable.
Imagine a hundred men and women seated in a room in the year 2030. This group is a perfect sample of the global population. Of those seated, a staggering 58 will be from Asia, 21 will be from Africa, while a mere 13 will be from Europe and North America. These demographic trends, presented in the report Population 2030 by the United Nations, are built on a concerning foundation: population will shift most significantly to countries with the lowest income. The population will also be older, with a 56% global growth in those aged above 60, bolstering the already immense costs of chronic disease management.
While there are tremendous advances in medicine, success can only be truly claimed when those drugs are accessible by the most vulnerable and underprivileged in our society. Naturally, price will be an important consideration in the next decade of medical technology, especially for high-volume disposable devices that deliver these drugs.
Even today, price can inhibit healthcare access, with a particularly pronounced impact on those in developing countries and the elderly.
New manufacturing techniques for volume production can open innovation, remove barriers to prototyping and facilitate trials needed to introduce new tools. To succeed over the next decade, new solutions and financial models are an absolute necessity.
Beyond improving access for most of humanity, lower priced disposable medical devices also present significant incremental revenue opportunities for medtech companies. Lack of adherence to treatments, especially for chronic illnesses, common amongst the elderly, is estimated to reduce the revenue opportunity for medtech and pharmaceutical companies by 40%, while resulting in poorer outcomes for patients.
Pharmaceutical waste, including lack of adherence to treatments, currently costs the NHS in the UK an estimated £300 million. One obvious remedy is to infuse connectivity technology into the drug delivery devices so adherence to a given therapy can be monitored, reported and improved.
Even with pronounced revenue opportunities, the upfront costs of innovation and integration can be prohibitive. In specific terms, the raw manufacturing cost for high-volume medical devices can be, in some cases, over twice as expensive than it needs to be, given the current technologies and processes deployed.
New manufacturing
The first significant target to be addressed is waste. The consumer tech industry has come to accept a lower manufacturing yield than would be viable in many other industries. In producing technology, there is a lot of wasted material, time and resources - whether from testing, excess wafer material, errant chips, or chemicals used for etching. For high-end smartphones or computers, the loss can be absorbed in the higher prices for these products.
Despite the different roles each type of medical device must play, they are often made from “off-the-shelf” components. While the current technologies and architectures have largely been cost-optimised in their existing forms, they may be more than is needed for the task the device must perform.
For example, most active medical devices are designed with general purpose, “off the shelf” microcontrollers (MCU) or System On Chip (SoC) that embeds many more peripherals and functions than actually needed contributing more cost to the product than the value it delivers in that application.
By rethinking construction, we can find new ways to generate manufacturing cost efficiencies.
Flex is helping customers realise innovation in the manufacturing process by developing new architectures, supply chains, materials and technologies to reshape this market for the next decade.
The first step is a rigorous design process to deeply understand the function the device must perform and how the patient will use it. Then to build exactly what is needed using the minimum number of components and complexity, so the device needs fewer tests to get to market.
One innovation Flex is currently deploying sees the entire manufacturing process move in a vertically integrated manner into one production line, working with raw materials as opposed to already-assembled parts. Flex leverages new technologies such as printed batteries and printed circuits on less expensive substrates and can manufacture tens of devices simultaneously at high speed in a roll-to-roll production process. This saves on individual product costs.
Tangible innovation
Until recently, the lowest cost substrate option, polyethylene terephthalate (PET), was largely out of reach due to high temperatures of traditional soldering. Photonic curing changes this, applying highly focused light that creates durable bonds without damaging the surrounding materials. Not only does this allow for a remarkable cost savings in substrate material, it also creates an incredibly fast assembly process measured in seconds, not minutes. When lower cost materials combine with faster manufacturing processes, we can realise fantastic manufacturing cost savings.
While leading edge today, this method of manufacturing will be mainstream for certain types of devices five years from now. Five to ten years out, we will have the opportunity to then add further efficiencies. While subtractive technologies are the only viable solutions for silicon devices, additive technologies represent the future in other fields, including, displays, batteries, interconnections but also simple active electronics circuits that provide intelligence to the entire medical device by counting events, monitoring sensors or controlling displays.
If medicine is intended to improve the human condition, then the future of treatment must be tied with that of humanity - one where nearly 70 of every 100 people will live in Africa and Asia, and the greatest population growth will occur in the countries with the fewest resources. There will be almost a third more people alive over the age of 60 in those regions than the number of men, women and children living in Europe and North America combined.
A decade from now, price and scale will be the largest defining factor of success. By connecting the dots of the technologies available today, we can establish some remarkable efficiencies and lay the foundation for more flexible additive manufacturing methods in the years to come.
This isn’t pie in the sky. This is innovation we’re pioneering right now, and it will change how we think about the design, manufacture, distribution and use of the medical devices required to serve the future of the human condition.
