Posted by Tristan Sedgwick on Fri, Sep 03, 2010
A Farm development case study on Cooper Surgical’s Trocar was recently featured in an article posted on Sustainable Minds’ blog. The article focuses on the development of a new trocar, designed by Farm, to replace the existing, fully disposable plastic trocar currently in use today. The new sustainable design features a re-sterilizable metal main body combined with a small plastic disposable tip.
One of the challenges for sustainability in medical devices is single-use disposable instruments. While single-use devices are preferred for infection control and may have usability benefits (no assembly required), they also create a large volume of waste that puts an increasing cost burden on hospitals as well as the environment.
Due to the material differences between the existing and newly designed trocar, Farm was interested in whether the re-sterilizable instrument would actually score better in a Life Cycle Assessment (LCA). Farm used Sustainable Minds’ LCA software to analyze the two designs. The result was an improvement with the combination reusable and disposable trocar scoring better based on the projected number of uses. The multiple re-uses of the metal trocar offset the higher material manufacturing and transport impacts. Even when factoring in the disposable plastic component over multiple uses, the re-sterilizable trocar still reduced environmental impact.
Farm realizes that sustainable product development creates real opportunities for competitive and economic advantage in the healthcare industry, including cost-effective manufacturing, optimized materials usage, minimized weight, and reduced waste. These sustainable strategies are part of the research, usability, design, and engineering philosophies that drive Farm’s product development process. If your mission is to meet specific sustainability goals, Farm has a dedicated, cross-functional team that is trained in sustainable product development.
Read the full article on Sustainable Minds’ blog.
Learn more about sustainable product development at Farm.
Posted by Chris Loughnane on Mon, Jun 07, 2010
Kaiser Permanente is raising the bar for it's suppliers.
From Fast Company:
We [Kaiser Permanente] evaluated the four major players and found that clinical performance and pricing were comparable, but there were big differences in terms of sustainability performance," explained Robert Gotto, the executive director in Kaiser Permanente's Procurement & Supply group. "One supplier had the foresight to develop a camera that doesn't need to be sterilized with chemicals. It uses steam instead, and can cut down chemicals in operating room by half." So the steam-sterilized endoscope provider ended up getting the five-year, $100 million contract.
Four OEMs. Each one indistinguishable from the next on the basis of cost and performance, but only one lands the $100M contract by virtue of its sustainability.
I was pumped to hear the news. Finally, a product selected on its sustainable merit. Surely this will lend credibility to the not-so-new green movement in the medical sector.
Much to my dismay, I found nothing regarding bioplastics, compostable materials, PCB reduction, or even alternative power. In fact, it seemed as though the only sustainable feature of the product was that it was able to be steam sterilized.
Steam sterilized? Well that's not terribly impressive.
Or maybe it is.
As much as sustainabiliphiles like myself tend to worship the latest widget on the front page of TreeHugger, Kaiser realizes it won't make any hay by demanding top-flight sustainable innovations from OEMs. Not yet anyway.
No, for now Kaiser has deemed it prudent to encourage device firms to test the water rather than push them into the deep end, and their Sustainability Scorecard is as simple and straightforward as you could ask for. At 13 line items deep, it's worth the 30 seconds to garner the insight into Kaiser's new strategy.
If you've got a few more minutes (or are wondering what Polybrominated Bipheyls are),
check out the breakdown of some key scorecard line items.
Is it a NICU Product?
Kaiser doesn't elaborate on why it cares if it's a NICU product. However, it's a good bet that if your product is going into the NICU, the importance of sustainable, healthy materials (especially with regard to RoHS, below) will be exaggerated.
Why?
Children are generally more susceptible to certain substances (such as lead), so allowing them to exist in products used on (or in) fragile infants would likely incline Kaiser to look elsewhere.
Is it a PICU Product?
Likewise.
Is it Latex Free?
The CDC estimates that anywhere from 1% to 6% of the general population, and 8%-12% of healthcare workers, are sensitized to latex.
That's not news... Latex has been a touchy subject for quite a while, and most medical device companies take precautions to avoid its use wherever possible. The result is that there are whole organizations dedicated to cataloging both consumer and medical latex-free alternatives.
Is it RoHS Compliant?
Although Kaiser Permanente fails to mention the EU's RoHS regulation by name, the prohibitions listed in the Sustainability Scorecard are identical to what has been banned in Europe for years.
Like latex, there aren't any surprises here. In fact, it's likely that the last time you heard the name of any of the substances listed below, it was followed by the word "poisoning."
The following substances can exist in quantities <0.1%
Lead (why it's bad)
Mercury (why it's bad)
Hexavalent Chromium (of Erin Brockovich fame)
PolyBrominated Biphenyls (PBBs) (why it's bad)
PolyBrominated DiPheynyl Ethers (PBDEs) (why it's bad)
The following substances can exist in quantities <0.01%
Cadmium (why it's bad)
The good news about all these restrictions? Printed circuit board manufacturers and custom polymer compounders (whose products are some of the biggest potential RoHS offenders) have been dealing with RoHS for years, and can help you with compliance.
Is it PVC + DEHP Free?
Polyvinyl Chloride (PVC) and Diethylhexyl Phthalate (DEHP) are bad news.
With countless advocacy groups sternly cautioning against the use of PVC and DEHP (DEHP is used to make PVC more flexible) in everday products like shower curtains, flooring, and credit cards, it's no surprise that Kaiser is pushing to eliminate it from products people have a much closer relationship with, such as tubing and catheters.
This concern has been around for a while as well, and though PVC-free alternatives do exist, PVC is such a great material otherwise that, although declining, use is still broad.
In any case, Kaiser has seen the danger in PVC for a while, and now they aren't buying it.
It will be interesting to see where sustainability in the medical field goes from here. My bet? It's only a matter of time before RoHS (or something similar) becomes law; and even if it doesn't, the great BPA backlash of 2008 exposed the kind of brand damage (Nalgene anybody?) that can occur when short-term thinking results in the use of controversial chemicals.
But regardless of what I think, the fact is that Kaiser Permanente wants you to be sustainable.
Right now that means complying with the Scorecard.
We should all be prepared for what it might mean tomorrow.
Posted by Beth Loring on Tue, Mar 30, 2010
A couple of weeks ago, I attended the Human Factors Committee meeting of the Association for the Advancement of Medical Instrumentation (AAMI) in Nashville, TN. If you aren't already familiar, AAMI is "a nonprofit organization comprised of nearly 6,000 members from around the world with a variety of different backgrounds unified by their commitment to increasing the understanding and beneficial use of medical instrumentation through effective standards and educational programs, and publications."
The Human Factors Committee convenes several times a year, and its members are responsible for writing the Human Factors standards that are adopted by AAMI and ANSI (the American National Standards Institute) and become best practices that the U.S. FDA expects device manufacturers to follow. This committee worked long and hard to develop the forthcoming ANSI/AAMI HE75:2010, "Human Factors Engineering-Design of Medical Devices." This nearly 500-page document will provide detailed Human Factors engineering design guidance, examples, checklists, and case studies. There is a delay in publication due to the fact that the publisher needs to obtain permissions for some of the figures it contains. It should be available for purchase shortly, but because it's so big, you won't be able to download it.
Another important development to be aware of is the FDA has officially endorsed the international standard IEC/ISO 62366:2007, "Medical Devices-Application of Usability Engineering to Medical Devices." IEC/ISO 62366:2007 calls for manufacturers to follow good Human Factors processes when designing medical devices, but does not provide detailed design guidance. Interestingly, Annex D in 62366 is almost a direct replica of ANSI/AAMI HE74, the document developed by this committee.
The meeting ended with discussions of diverse topics, such as post-market surveillance, user interface design for medical software, and guidelines for observational field research. The group is deciding which initiatives to pursue next.
In addition to hearing about these developments, it was a great opportunity to get a behind-the-scenes glimpse at the work that goes into creating, editing, and approving Human Factors standards. It was an insightful experience and a pleasure to finally meet some of the members that make up this influential group of thought leaders. I highly recommend attending if you're interested in Human Factors standards.
Posted by Jack Harkins on Thu, Feb 18, 2010
Have you seen the recent Verizon FiOS ad on television? The one where a focus group is being conducted on high-speed fiber optic service? After the users weigh in, the technician (cable guy) asks why they are talking to users anyway. The Verizon tech (smart guy) only needs to say "oh boy" to make the point that the competition just doesn't get it.
I've been in the product development business for forty years and the industry has come a long way since the early '90s. Back then there was marketing and there was engineering. One was focused on the competition and the other was focused on the technology. We in the design community talked about the importance of user needs research, but it was serious missionary work back then.
Today companies are acutely aware of the importance in understanding the end-consumer's needs but have been slow to adopt a rigorous process to meet those needs, even those companies in the medical device industry. Over the last five years, the FDA has strengthened its emphasis on usability and human factors guidelines. This requires companies to demonstrate best practices, including field research to learn user needs, preference testing of early concepts with customers, and usability testing of both prototypes and pre-production units for verification and validation. Rather than testing individual devices for safety and efficacy, there is a renewed focus basically saying- there's a right way to do this and we will evaluate your process to make sure you did it that way.
This is a blessing in disguise for device manufacturers due to the fact that it can provide many competitive advantages such as significant cost reductions, including the prevention of expensive device modifications. Medical device manufacturers are also able to minimize risk on liability and recall expenses. User research and validation ultimately yields a product that is easier to use, quicker to adopt, and improves patient treatment.
With user needs research lives have been saved and accidents associated with improper usage are now being avoided. With all of these positive aspects, it's still confusing to me why companies don't leverage the user research benefit earlier into the development process. Why do you think companies are so reluctant?