In this new regular feature, Healthcare Packaging is interviewing some of the best and the brightest in the industry to learn more about their careers, their thoughts on what has changed over the years within the industry, and what challenges are arising. Dive in for some insights and interesting tidbits from your peers.
First up, meet Matt Picha, COO of Anexa Biomedical. Picha talks with us about the importance of continuous improvement and the substantial changes he has seen in the regulatory landscape.
Q: What is your name and position? How long have you been in this role?
My name is Matt Picha and I am the COO of Anexa Biomedical. I have actually been in this roll for two months, however, I was previously the VP of Operations for a different manufacturer for 6 years. I have been in a variety of different roles in Quality, Operations, and Manufacturing in the medical device and pharmaceutical manufacturing field for 29 years.
Q: How did you get into packaging, what attracted you to it?
I was hired by a pharmaceutical company right out of college as a Quality Assurance Technician to perform in-process testing, review documentation, and perform product release duties. At that time, I was unaware of the intense regulatory oversight associated with pharma/medical device manufacturing. As I started to learn several different quality systems, I became interested in developing and implementing new systems to improve quality and efficiency. As my career in the field continued, I became, and am proud, of the fact that the work we do can make a positive impact on someone’s quality of life.
Q: What has been the most important skill you’ve developed as you advanced your career?
I have found that being open to change is one of the most important skills. Additionally, continually advancing your education in manufacturing quality/operations utilizing certifications such as ASQ, Six Sigma, and ISO are important. Challenge yourself and those around you to have a continuous improvement mindset.
Q: What has changed the most in your career over the years? What are you most surprised at?
Over my career, the regulatory landscape has evolved the most. Over the years, risk management and validation of processes have become two important quality systems as well as real time control of processes. These items weren’t as prominent at the start of my career. Harmonization of the FDA and ISO guidelines will be a positive change creating a level of consistency.
Surprisingly, the U.S. has over 100 drugs or active ingredients on the shortage list. While this has improved over the last 15 years, it is important that we do what is necessary to ensure everyone has availability to these medications.
Q: What advances have been made in the sterilization space?
X-Ray sterilization is one area of advancement in the last 15 years that has improved the capacity to sterilize medical device products as the gamma sterilization capacity has been limited the past few years. We are seeing multiple X-Ray sterilization facilities completing validation activities and starting up that are able to sterilize high density products. This area has had no or limited capacity in the past.
Q: What do you see as the biggest challenge or biggest opportunity in the pharmaceutical/ med device industry? How does packaging help alleviate this challenge?
Our biggest challenge as an industry is creating cost effective drugs without comprising the safety, efficacy, and quality of the drugs. Developing new drugs/medical devices coupled with the cost of regulation makes this a difficult task but one that we need to tackle. Automation in packaging has improved the ability of a production line to be efficient in operation and labor costs long term. That wasn’t the case 30 years ago.
