Growing Up With Compliance: Reflections on 15 Years in Healthcare Compliance

By Andy Bender

Since its inception in 2001, Polaris has been at the forefront of the Life Sciences compliance industry, a sector that has experienced phenomenal growth and evolved in myriad ways as it has matured.

The Birth of An Industry

The business landscape in the early 2000s was a challenging one. Large companies such as Enron, Tyco and Worldcomm were making headlines, failing the public trust. Pharmaceutical companies were under intense scrutiny by the OIG, resulting in investigations, prosecutions and landmark settlements.

Realizing the industry had to make some radical changes to adapt its business model to this new environment, the trade group PhRMA, Pharmaceutical Research and Manufacturers of America, developed an industry code.

Polaris was launched with the mission to instill transparency and compliance within the pharmaceutical industry, and help restore the public’s trust. The general trend to digitize processes and information, as well as the rise of social media accelerated the need for transparency and compliance in the pharmaceutical and medical device industries further.

The first services Polaris offered focused on helping US based pharmaceutical companies establish compliance programs in reaction to investigations from the government. As part of the seven elements of a compliance program, we helped companies develop codes of conduct, policies and procedures and SOPs, conducted audits and helped with monitoring of events.  Some of Polaris’  first solutions were audit guides; resources used for outlining and documenting audits in all compliance risk assessments, that were also used to train clients on how to conduct audits on their own.

Adolescence Approaches and the Birth of our Technology Business

As the compliance industry matured, the Polaris team realized that many of the processes we were developing and recommending required additional controls, making our recommendations resource-intensive.  At the same time, our clients were being inundated with additional compliance requirements and controls, making compliance inefficient from a business perspective.  To alleviate this burden, Polaris crafted technology solutions to address the inefficiencies created by the regulatory environment.  We developed best practices, then translated them into technology applications and packaged them as products all clients could benefit from. The first software solution we launched was the Polaris Grants Management Process.

Our technology business emerged.  Polaris was building a reputation as a software and technology business that developed best-in-class, automated and online processes that allowed its clients to benefit from its collective insights and curated best practices. The strategy was to develop a business model that provided compliant solutions, was practical, provided bottom-line efficiencies, and recurring revenues that would allow us to invest in developing future solutions. With this strategy in place, our Software as a Services (SaaS) business was born. A SaaS business model would deliver a steady, stable cash flow in the long term that would allow us to invest and develop new solutions and services as the compliance landscape changed and matured, growing with our clients’ needs.

As the industry matured, Polaris was maturing right alongside our clients.  We constantly asked ourselves “What challenges would they face next?”  This gave birth to Polaris’ renowned “What’s Next?” initiatives. Adopting this “What’s Next?” philosophy would ensure that Polaris stayed at the forefront, relevant and could help set the industry’s agenda.

Our Teenage Years – Becoming a Better Business

The growth of our technology business did have its challenges.  To deliver a quality product, that was On Time, On Budget and On Scope (OTOBOS), resulting in satisfied clients, we had to start formalizing our processes and procedures.  Polaris had to go onto a “fitness program.” In 2008, we started the first internal project to take our fitness to the next level: Process Excellence.  Process Excellence set common standards on how we ran and managed a project.

In 2010, we formalized Polaris’ Customer Satisfaction objectives for our delivery and support organizations, and set about relentlessly measuring these objectives. We set exacting standards and expectations for performance, created our account management programs and implemented quarterly reviews of our clients’ satisfaction.

A year later, we formalized the Polaris Value Statement, that enabled our staff to make decisions based on a common set of Polaris values and norms. That helped create today’s process in which every person’s goals are tied to the overall company goals, in addition to his or her personal goals for growth and development within the organization.

More recently, in 2015 and 2016 we have been implementing Project Evolution, refocusing and crystalizing our strategy to reflect the ever-evolving industry and marketplace in which we work. As the market has matured, our clients expect our products to be implemented faster, to be integrated as a compliance platform, have a global footprint, and be delivered at a lower cost with higher quality.  In order to accomplish these objectives, we implemented a Product Roadmap, with a dedicated Product Team responsible for understanding and identifying our client’s needs and requirements, then translating these into a consistent framework for future deliverables for each of our technology products.  Our vision is to develop products that can be delivered as “out of the box” solutions requiring few customizations, being highly configurable.

Maturity and Trends on the Road Ahead

The market and our clients continue to change and evolve.  For example, originally many of the compliance tasks were headed and managed by our clients’ law and compliance departments. Over the last few years, the ownership has transitioned to the business; business defined as Sales, Marketing and Medical Affairs departments, parts of the organizations that have direct contact with Health Care Practitioners and Organizations (HCP/Os).  The business is seeking compliant solutions that are efficient and scalable, while also providing them with a competitive advantage through technology and access to data.  An apt analogy would be having seat belts and airbags in the automobiles we buy nowadays. We automatically assume they are included features in any car we buy, but wouldn’t be the main reason we make the purchase.

Going forward we see two major trends:

  1. Our Clients Want Global Solutions

The US government started with prosecution of pharma and device companies in the US, and by using the Foreign Corrupt Practices Act (FCPA), has expanded its reach to prosecute companies outside the United States.   In addition, other nations around the world have joined the effort for better compliance and spend reporting, raising the ethical standards that companies are being held to by instituting Anti-Bribery and Anti-Corruption Legislation.

  1. Our Clients Want More Benefits from the Data They Collect

Transparency reporting has fueled the unquenchable thirst for data, creating a tremendous desire to collect additional information for strategic purposes.  Several of Polaris’ clients are starting to collect information beyond the required spend reporting, and are combining spend data with other data sources in the organization, serving strategic business purposes, leading to an evolution in this field.

In our “What’s Next?” quest, Polaris is finalizing several solutions that will allow our clients to not only collect, combine and analyze available data, but also interpret and utilize the information in myriad other areas of the business.

The Road Ahead

Polaris has grown from 1 person in 2001 to 150 people in 2016, with an additional 200+ people as independent contractors.  We have grown between 20-25% per annum since 2001.  Part of our success has been our culture, and our people, striving to identify our clients’ needs and industry trends, constantly asking ourselves “What’s Next?”, thereby staying relevant, and setting the direction for our clients.

A major part of Polaris’ success has come from our consulting business, which has been the incubator of most of our technology products.  A great number of our technology ideas have come from the consulting group.  Comprehending the compliance requirements, translating these into processes and understanding compliance trends, has enabled us to better understand what technology applications our clients require to be efficient.

The impact that the Polaris team has had on the compliance landscape in the US has been tremendous; past, present and future. Polaris has launched over 160 successful systems, with most of our current implementations being global.  Our software is being hosted on three continents, with more than 55,000 users on our system, a number that will double over the next two years, processing more than $1.5 billion in transactions throughout our systems annually.