Parcus Medical is an orthopedic medical device company based in Sturgeon Bay, Wisconsin. Parcus designs and manufactures a variety of interference screws, suture anchors, and orthopedic procedure accessories. My business partner, Scott Durlacher, started working with the company in 2008, assisting Parcus with quality system and regulatory needs. The founders of Parcus knew and worked with Scott several years ago and decided to bring him in to help them launch several products. Parcus was a client of Scott’s consulting practice, a business that he established years before he and I teamed up with Creo Quality. He was able to assist them for a couple years, and decided to bring the full Creo Quality resources on board during the summer of 2010. Our primary objective was to put Parcus Medical in a position where they no longer required Creo Quality services.

The Creo Quality approach implemented was a balance of strategy and tactics. Scott’s focus was to continue to assist the company with quality and regulatory needs and consisted of getting Parcus products registered in identified strategic markets. My focus was to audit the company’s quality system and business processes, assessing regulatory compliance while ensuring processes and procedures are not overly burdensome. Scott and I are a good team, providing an approach of checks and balances while directing our clients towards their strategic vision. The Parcus engagement was a great example of this. Scott worked closely with Parcus management, identifying products and markets to expand the business while driving regulatory product registrations. I established the internal audit program of the Parcus quality system, a system Scott had previously implemented. Since 2008, Parcus Medical has been experiencing steady growth. Our challenge was three-fold:

1. Transfer knowledge and responsibilities of day-to-day quality and regulatory needs to in-house Parcus resources.
2. Help “right size” Parcus business practices for continued regulatory compliance and company growth.
3. Transition from providing tactical consulting services to providing strategic business direction.

We anticipated the Parcus engagement could be 12 to 18 months. Because Parcus Medical has limited resources (by good design, by the way), we expected transferring day-to-day responsibilities would be the biggest challenge. After just a few months, however, we were pleasantly surprised at how quickly the in-house resources were able to accept and successfully manage quality and regulatory needs without compromising other aspects of the business. By the end of October, Scott’s role had been nearly 100% absorbed by Parcus, and I completed internal audits of the entire company quality system. While we haven’t assisted the company much with business strategy, we were able to accomplish our primary objective in under six months. Why?

• Parcus Medical management. From the beginning of this company, the management has had the proper focus: work quickly to introduce products into markets with revenue potential, while ensuring regulatory compliance.
• Parcus resources desire for growth. The company resources are hungry and have the curiosity to take on significant responsibilities and pushing the limits to help the company be successful.
• Creo Quality approach. The Parcus Medical engagement is just like any other Creo Quality engagement. We assessed the current situation, identified long-term objectives, and worked quickly to implement sustainable solutions.