22. January 2018
When thinking of the start of revolutionary advancements in an industry, its imagery tends to hold a common theme: a small group of creative minds tinkering in a garage, on the cusp of a breakthrough with their big idea.
While it can come across as a storybook, romantic notion, it’s a theme that holds some truth in the medical industry. There are roughly 7,000 firms in the medical device sector. The vast majority are small or medium-sized companies with intense focus on a single product or medical condition.
The creative minds in this circumstance are highly specialized in their focus on medicine and have facilities much better than the garage. They also have neighbors – lots of them. They form an expansive ecosystem of manufacturing, design, packaging, and regulatory experts with the skills to get a product over the finish line – if they work together.
To meet and exceed patient needs while maintaining a healthy bottom line, medical device manufacturers must reduce time to market. To do that, they must lean on their suppliers as resources to navigate an increasingly competitive marketplace.
Small companies, big networks
Medical devices can have surprisingly short product lifecycles, just 18 to 24 months in some cases. Competition with other firms, feedback from physicians, and a complex regulatory environment have forced an ever-quickening tempo in the industry that manufacturers must be able to constantly adjust to in order to keep up.
Those shortened timelines compound the competitiveness of an industry faced with rising healthcare costs, intense competition from new market entrants, and evolving global regulatory challenges.
Highly specialized small-to-medium enterprises (SMEs) benefit tremendously from a more agile business structure with fewer layers of decision-making and red tape. Quite often, however, they don’t possess the depth of knowledge or the resources to solve some of their most difficult challenges.
To survive, smaller companies need to tap experts into a product ecosystem for help with advancement of R&D, optimization of manufacturing chains, enhancement of product design, and solutions for packaging dilemmas. By engaging in collaborative practices, these companies stand to benefit from reduced time to market while enhancing — not sacrificing — performance and quality.
To understand how vendors and a network of experts can help small and medium-sized medical device manufacturers, we can look at an example. Imagine a medical device engineer wants to improve an instrument by integrating an LED module into it. Instances like these create opportunities to re-examine the device components and find materials and parts that elevate the device’s performance while offering longevity, durability, and possibly even cost improvements – all appealing qualities for an end user.
In this instance, the medical device engineer looks into traditional LEDs, which typically use organic-based packaging materials such as silicon and epoxy to encapsulate the bulbs. However, after consultation with surgeons and hospital technicians with experience in the field, it is determined these organic materials are on the path to obsolescence.
The silicon packaging is not the market’s topline solution because it does not adequately protect the sensitive LED chips from the harsh conditions of the autoclaving process. As many hospital technologists know, exposure to heat, moisture, and chemicals degrades silicon and plastic materials over time, which leads to premature failure of the protective barrier.
This can happen after just a few steam sterilization cycles, requiring costly repairs or replacements when the LED’s glob top sealing no longer adequately protects against the autoclave’s elements.
The engineer reaches out to several experts for a solution, some of whom are vendors, others engineers at related companies with experience in similar device challenges that are not direct competitors. Finally, a strategy is determined for building an autoclavable LED system.
In this scenario, integrating an LED module made with autoclavable glass-to-metal sealing technology improves the durability by swapping out permeable injection-molded plastics and silicon materials for a gas-tight assembly. This change might seem small, but this upgrade offers significant benefits: Only housings made with purely inorganic materials such as glass, ceramics, and metal can offer long-term resistance against the harsh conditions of the autoclaving process. These improved materials can withstand several thousand sterilization cycles without seal compromise.
Such attention to detail in material selection can have lasting effects. The improvement in quality and performance can make a lasting impression on users, encouraging brand loyalty by way of a reputation for quality and reliability.
Streamlining R&D amid shorter product life cycles
Medical device manufacturers invest approximately 7 percent of their revenue into research and development, according to Kalorama Information research. By some measures, that is a higher level of investment than other manufacturing sectors, including automotive and aerospace businesses.
The result of this is the development of components that can withstand the requirements of the devices they are integrated into. In this case, autoclavable glass- or ceramic-to-metal-sealed components have been put through sterilization testing that has proven they are able to withstand the autoclaving process over 3,500 times in conditions of approximately two bars of pressure at 275 degrees Fahrenheit. After exposure to such conditions, they have maintained hermeticity while still delivering high optical performance.
For medical device designers, these results demonstrate strong performance in applications where frequent use and constant sterilization are necessary. For end users, this means high reliability and less downtime spent on repairing broken components.
Clear benefits to collaboration
By collaborating with materials experts, medical device manufacturers can minimize testing timeframes for new or updated products, accelerating speed to market. By increasing durability and extending the life of devices, health care organizations save money through lower cost of ownership.
Integrating quality components that support multiple product iterations also helps reduce costs and eases manufacturing processes by minimizing disruption – updates, changes, or new product development don’t come with the burden of reinventing the wheel.
Collaborative practices aren’t just a feel-good ideal: one study by McKinsey & Company saw that manufacturers who collaborated with partners saw growth rates 196 percent higher than manufacturers with no collaborative projects in the pipeline.
That, if nothing else, should encourage advancement in medical device developments through collaborative practices.