The PCL team will be headed to Anaheim, California next week for the MD&M Anaheim tradeshow. Stop by our booth to race some FAST cars and enter the chance to win an Amazon Echo!
As we get into the New Year, it is pertinent to be aware of new laws and regulations that may affect our industry in 2018. As an example, The Food and Drug Administration (FDA) recently announced plans for a new approval process to speed medical device products’ entry to the U.S. market. The new approval process will allow certain devices to go to market with initial approvals, with further evidence to assess performance coming later. While the process will not apply to all categories of medical devices, low-risk and well understood technological areas such as ultrasound and cholesterol blood tests will be affected first. When interviewed, FDA commissioner Scott Gottlieb described the new process as a “progressive” move to promote innovation and clear barriers to new business in the medical-device industry. Furthermore, Robert G. Hauser, a cardiologist and former device-company executive whose primary research interests have included device safety, said “investment in medical device technology is suffering because of FDA delays.”
Our lab technician, Sydney Eggleston, has been featured in a recent publication for Medical Design and Outsourcing Magazine! In the article Sydney highlights the process your medical device goes through while compleing validation testing through our lab. It is an interesting dive into the "life" of a medical device package in PCL!
You may not be aware, but Packaging Compliance Labs is the official test lab of The North Pole. Every year since our company was founded, Santa has been sending packages our way for testing before Christmas. Santa’s trip is wrought with peril, and he wants to make sure he doesn’t break little Billy or Susan’s hearts by leaving a broken toy under the tree. Seriously, who wants to deal with that sort of drama on Christmas? Not you, not Santa, and certainly not PCL.
Last week PCL hosted the West Michigan Institute of Packaging Professional’s (IoPP) quarter event. This event included package testing demonstrations and an exclusive presentation from Eric Hiser, the Technical Vice President of ISTA (International Safe Transit Association). It was truly a unique experience seeing Eric speak about standards while standing right next to a complete transit simulation set up!
Here at Packaging Compliance Labs we are consistently looking for opportunities for streamlining work and reducing waste while still focusing on quality to better serve and add value to our customers. To accomplish this, PCL uses Lean methodology to identify opportunities in the process of workflow, plan how the current process can be improved, execute and implement changes, and set metrics to review how the changes are working for our team and our customers.
Conditioning samples for testing is much like preparing a Thanksgiving dinner. Considerations need to be taken regarding storage and preparation to ensure that proper temperatures are used for the correct amount of time. Your Thanksgiving turkey is likely transported and stored in a frozen state, both to ensure it stays fresh until sold, and also to prohibit the growth of microorganisms such as E coli and Salmonella. If you cook that turkey for too long or at too high of a temperature it will likely be dry or burned, an unfortunate scenario since most people don’t like dry, crispy turkey (right, Clark?). Likewise, if you cook your bird at too low of temperature, you run the risk of undercooking it, which can lead to growth of microorganisms that cause foodborne illnesses (just like improper freezing). The goal is to find the perfect temperature and time – hot enough to cook the bird all the way through, but not long enough to burn it.
ASTM held it’s semi annual meeting in New Orleans on October 8 – 13th. PCL attended the first half of that conference focused on committee D10, which includes standards such as conditioning and transportation simulation. What an experience! It was a great opportunity for PCL to make valuable contributions to discussions about several key packaging standards and also understand potential changes coming down the pipeline. Here are a few takeaways affecting medical packaging that we thought were interesting:
September typically marks new deadlines in the rollout of FDA’s Unique Device Identification (UDI) final rule. That’s not the case this year – FDA’s next deadline doesn’t go into effect until 2018 – but we want to use the opportunity to provide a refresher.