Case Study: How a Thriving Medical Devices Co. Overcomes Legal Hurdles with Strategic Team Expansion

Client Challenge

A fast-growing medical devices company’s small but mighty legal team faced tremendous, multifaceted challenges in three areas:

1) Their existing global clinical trials attorney was drowning in work and needed the support of a subject matter expert and skilled negotiator to come in and support their abundant clinical trials work. 

2) The commercial contracts team was facing tremendous demand from the business side.  They lacked an effective CLM process and procedures to address the growing number of procurement contracts (e.g., DPAs and various IT agreements). They needed to merge their newly developed templates and clauses with their legacy contracts.

3) The privacy team needed a knowledgeable privacy professional to flag privacy issues for compliance with EU and US Privacy laws.  Soft skills were critical as the support needed to be highly organized, adaptable to their high-risk tolerance, and able to prioritize essential business decisions.

Paragon’s Solution

After listening to the challenges and needs of the three hiring managers and fully understanding their internal processes issues, goals, and budget, the Paragon team knew they had to have a holistic, multi-step solution that not only addressed bandwidth in three separate areas, but also solved their contract life cycle management/administrative infrastructure bottlenecks.  First, they provided the client with an experienced contract manager/attorney with an extensive background in drafting, reviewing, and negotiating multimillion-dollar commercial contracts in various industries.  The contract manager was also highly skilled in multiple CLM, ERP, and Document Review solutions.  With the contract manager helping to solve their administrative CLM challenges and bringing efficiency to the overall process, Paragon then deployed a 20-year experienced attorney with domestic and international laws within corporate research and development, clinical trials, licensing, and product marketing.  After addressing the client’s CLM structural issues and giving the clinical trials team a much-needed lift, Paragon embedded a privacy professional experienced in privacy matters and regulatory compliance in pharmaceutical, healthcare, and medical devices, to help the privacy team ensure compliance with both EU and US privacy laws.

Benefits & Savings For Client

The client was pleased because Paragon did not just rush in to throw three professionals at the problem at once without first working with the client to strategically solve the structural CLM process issues that were impacting all three functions.  Instead, Paragon helped the client methodically lay down the framework needed to address their long-term issues.  The client was able to iteratively leverage Paragon’s dynamic trio at a combined hourly rate of $605 per hour ($230/$225/$150).  This is a considerable value proposition as the equivalent outside law firm team of 3 to 5 subject matter experts and their respective support teams to address the variety of subject matter needs, with niche industry know-how, would easily exceed $2,000 per hour.  Over the approximately one-year life cycle anticipated for this engagement, the client will realize a net legal cost saving of over 2.3 million dollars by leveraging Paragon’s flexible, high-caliber talent.