Increasing Quantity, Maintaining Quality

By: Alexandria Mason
August 14, 2020

John Honkanen still remembers his first day as the Quality Manager at Biocut Systems.

It was pretty straight forward: “I was told there’s your desk, now go be a Quality Manager.”

Coming from a background of mechanical engineering, quality and operations and two decades of experience in the automotive industry, Biocut Systems was Honkanen’s first opportunity to utilize his skills in the medical field and take a step back from a world which was becoming too comfortable.

“I looked at it as a challenge — The opportunity itself, being a relatively small company, but a rapidly growing company. I don’t thrive in a stagnant environment. I thrive in one that’s constantly changing and evolving –that’s what I enjoy,” said Honkanen.

Now four years later, his role has evolved and expanded to Director of Operations overseeing production, shipping, receiving, quality and manufacturing engineering.

While engineers and designers handle the creation and testing of the prototype bioprocessing equipment, Honkanen plays a crucial role in product longevity. “My main focus is taking a concept/prototype from where it is developed… to where it’s going to begin production and then through all of the production steps/repetitions for the rest of that product’s lifecycle.”

One of Honkanen’s greatest tasks is to ensure all of these steps meet the same quality standards for every customer. Biocut Systems abides by the International ISO Quality Management System, specifically ISO 9001. These standards implement practices that formalize training and legitimize consistent procedures for each product.  The standards that go into this certification, many times translate into customer trust and satisfaction and more opportunities to expand into a global market.

“The definition of quality means, the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs, basically getting what you’re asking for, getting the price you ordered it for, and getting it in the time you’d been promised,” said Honkanen. “Being in the medical device space some things are really emphasized, for example, traceability of materials; making sure our customers understand what exactly went into their products, if anything were to happen, they are able to trace back all the raw materials that were used in the manufacturing process.”

Prior to Honkanen’s arrival, there hadn’t been a specific standard in place. ISO certification helps the company increase its inventory offerings without compromising the integrity of their products.

“The reason I was hired was to develop the Quality Management System. Knowing the company was “directionally” moving away from the printing, packaging and leathermaking industries and into the medical device industry, we needed to have a robust, mature quality system. That’s what I was brought here to do, for the first year, until the time of the (Stuck) acquisition it was my main responsibility: developing, implementing and training in this area.”

Much of the current growth in the company, Honkanen attributes to an expansion of machinery.

“The biologic die cutting side of our business is really mature, but the machinery side has grown quite a bit. That’s been fun to participate in all of the things that are different and thus in creating an assembly-type operation.”

As the company continues to expand its inventory offerings, maintaining these standards are critical for success. Honkanen says over the next two years he wants his team to focus more on an inventory control system to not only properly maintain existing products, but also to support future creations.

“Launching all of the new products we’ve got in place is going to be a big area of focus. We’ve had a number of new products and are constantly launching more,  which we’re out in the marketplace promoting… that growth leads to more growth, which is a great thing,” said Honkanen.

“My primary area of focus is to just keep the entire organization working together as a team to do what we have to do on a daily basis to satisfy our customers.”