The Science and Art of Sustainable Medical Device Design
David Rutledge
CEO & Founder of Global Strategic Solutions, LLC | PRRC for the Medical Device Sector | Best Selling Author, Mythical Medical | Podcast - What's in Your Strategy? | Lead Auditor ISO 13485 | Notified Body - BSI Trainer
Medical device manufacturers are being asked to look at ways to create sustainable medical devices to help reduce the industry’s carbon footprint. However, it’s not an easy process moving to sustainable medical device design as there are several things to consider in the process.
We’ve put together this guide to share with you what you’ll need to know about the science and art of sustainable medical device design.?
Designing Medical Devices With Sustainability in Mind
Sustainability has become an essential part of the business model of many industries, and the medical device industry is no exception. The medical industry can help reduce its global carbon footprint by developing sustainable medical devices. Here are some items to consider as you begin sustainable medical device design.
Selecting Sustainable Materials
One of the first things to consider in sustainable medical device design is if you can make the device from sustainable materials.
Here are some considerations for selecting materials for sustainable medical devices:
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●??????Look to make the device out of a bio-based material instead of a petroleum-based one.
●??????Try to reduce the number of materials the device is made from so it’s easier to recycle at the end of its lifecycle. ?
●??????Try to utilize stainless steel and glass in the design so the device can be reused and refurbished.?
●??????Use recycled materials like polyethylene terephthalate (PET) that don’t lose their technical properties after their first use and use fewer greenhouse gasses when recycled. ?
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Build Sustainability Into The Design of the Device
It’s crucial to incorporate sustainability into the device from the initial stages of the design of the device instead of trying to reverse engineer solutions later in the process. When looking at developing sustainable medical devices, another thing to consider is trying to reduce the size and weight of the product to minimize the number of materials needed to create it. ?
It’s essential to try and look for ways to shrink and minimize the use of electronic components to reduce the impact of disposing of them at the end of their lifecycle. If the device needs batteries, look at finding a way to reduce the size of the batteries required. Or, look to use sustainable battery sources like rechargeable batteries. ?
Making medical devices smaller and smarter demands several critical qualities from the components used to produce them. For example, nickel-titanium is a unique alloy with two defining characteristics: strain resistance and ‘shape memory.’ Remember, the size must be reduced without compromising quality, application-specific attributes (a flexible guidewire) must be reliable, and biocompatibility must comply with stringent medical industry standards and local requirements.?
Read how making a significant change in your medical device might affect your approval process in the EU.?
Design With Recycling and Reprocessing In Mind
Another way to make a medical device more sustainable is to convert it from a single-use device to a device that can be recycled or reused. Recycling and reprocessing medical devices are more likely to be contaminated by blood and other substances, making it easy for healthcare professionals to toss devices into the red bag for incineration. However, a study by the Association of Medical Device Preprocessors indicated that 100% of top U.S. hospitals use reprocessed single-use medical devices and 39 out of 39 military hospitals.??
With healthcare facilities in the U.S. generating an estimated one million tons of non-infectious plastic waste annually, there’s a tremendous opportunity to increase the amount of recycling in the industry. The US FDA has an informative discussion on reprocessing reusable medical devices. See their guidance document here.?
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Work With The Right Manufacturing Partner
It’s essential to work with the right manufacturing partner for the product of sustainable medical devices. Here are several factors to consider when choosing the right manufacturing partner:?
●??????Make sure they have the engineering expertise and experience in manufacturing your device. ?
●??????Look for a partner that is serious about environmental sustainability. Verify that they are following environmental best practices for the disposal of waste and carbon capture. See if they are using manufacturing options that reduce water and energy use. Do they have a LEED certificate??
●??????Work with a manufacturing partner who clearly understands your product’s performance requirements and overall goals for the product.??
●??????It’s essential to consider the device’s packaging and whether it can be recycled, reused, or composted.
Consider The Supply Chain and Transport of Your Device
The materials a medical device is made from are significant drivers in the overall carbon footprint of a medical device. However, the supply chain and transport of the device are also essential to consider. ?
Another thing to consider is the strategic location of the manufacturing locations and warehouses to minimize the distance the medical devices need to be shipped. In addition, being able to ship within a region helps reduce the carbon footprint of medical devices.??
For example, container ships often used for oceanic transport are one of the most egregious contributors to greenhouse gas emissions. According to one report, it only takes 15 of the largest container ships in the world to produce the same amount of pollution created by every car in the world combined.?
Work With a Consultant Group With LEED Consultants
The design of sustainable medical devices is complicated. For many companies, it’s challenging to transition to thinking about sustainability in the design of a device unless doing so produces significant cost savings. A consultant group like Global Strategic Solutions, which has a LEED-certified consultant, can significantly benefit a company moving toward sustainability. The expertise and guidance of a consultant can help manufacturers, and product development teams better understand the factors that impact the material design of a product. A consultant can also help an organization navigate the clinical and regulatory minefields inherent in the medical device industry.?
Think About Sustainability Early in The Design Process for Medical Devices
The medical industry is increasingly looking for ways to reduce its carbon footprint. One of the key ways they can do this is by designing and producing sustainable medical devices.?
There are several factors to consider in sustainable medical device design. Both the materials the device is made from and how easily it can be recycled or reused should be regarded as early in the process.?
You’ll also want to partner with a manufacturer as committed to sustainability in their manufacturing process as you are. It’s important to remember that producing the device is one thing, but transporting it to your customers worldwide also tremendously impacts its carbon footprint. ?
It’s always a good idea to work with a consultant with experience in sustainable medical device design who can help guide you through the process.?
David R Rutledge, Pharm.D. FCCP, FAHA, President & CEO
Best Selling Author and ISO 13485 Lead Auditor
A really nice summary, thanks David Rutledge. I agree that this should be baked into the design process, not just an afterthought. I also (theoretically) look at it similar to benefit-risk. E.g. does the 'cost' of the reprocessing (in terms of materials used, energy expended, waste materials generated etc.) outweigh that of the single use device.
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1 年Wow, I love this concept! 1. Materials selection 2. Size reduction 3. Consider recycleability 4. Consider manufacturing processes 5. Packaging & Transport 6. From the beginning, think about what's even going into the design of your product. There's a lot more to sustainability than what typically meets the eye. Fantastic article, thank you for sharing David!