Phase 3 - Compliance Officer Consulting

Even with a fully developed Compliance Program in place, many small and start-up medical device and pharmaceutical manufacturers are not prepared to maintain and evidence the effectiveness of the company's compliance program.  Typically, compliance responsibilities are added to the existing full-time duties of one of the company officers.  As a practical matter, the focus on growing the business limits the company's ability to effectively manage its compliance efforts.  At the same time, companies that have a goal of acquisition or financing cannot afford to minimize the focus on compliance.  For those who are not experienced in compliance, managing a compliance program in the high-risk device and pharmaceutical industry can be overwhelming.  Effective guidance is required from experienced compliance professionals.  


JD HealthCare Partners, LLC professionals have spent their entire careers in all phases of compliance.  Finding the same level of compliance experience in full-time professionals would not be affordable.  For that reason, JD HealthCare Partners, LLC provides compliance officer consulting ranging from assistance to full outsourcing of the compliance officer function.


The Compliance Officer function includes:

  • ​Overseeing the company's Compliance Committee meetings
  • Performing compliance risk area audits
  • Responding to compliance questions and conducting compliance investigations
  • Providing general and risk area specific compliance training
  • Sanction screening audits
  • Periodic compliance reports to the Board of Directors

You have worked hard to prepare your medical device or pharmaceutical company for an acquisition.  All the pieces are in place for a smooth due diligence process...or so you think.  

  • Do you have an effective Compliance Program?
  • Are you prepared to provide satisfactory responses to challenging questions about your Compliance Program?

Like it or not, the path through due diligence must travel through compliance.  How your company prepares for compliance due diligence can be the difference between a successful or failed acquisition or financing event. ​

Phase 2 - Operationalizing the Compliance Program

Compliance risk increases significantly once the company begins to commercialize its products,  With a solid Compliance Program foundation in place, the operational components of the Compliance Program can be created to address the added compliance risk.  The goal of Phase 2 is to add the function to the foundation of the Compliance Program built in Phase 1.  


Key objectives for Phase 2 include:

  • Developing specific compliance risk area policies
  • Establishing the confidential reporting mechanism or hotline
  • Developing and delivering general compliance training to all employees
  • Establishing a sanction screening process
  • Developing investigation, response, and discipline protocols
  • Conducting a compliance risk assessment
  • Establishing the compliance audit workplan
  • Develop a process for tracking and reporting payments to physicians (Sunshine Act Reporting)

Phase 1 - Building the Compliance Program Foundation

Whether just starting or already commercial, the Compliance Program Foundation should be integrated into the company's operations as early as possible.  The Compliance Program Foundation includes the structural documents and key policies that shape the Compliance Program.  It is upon this foundation that the remainder of the Compliance Program can be built.  Early integration of the Compliance Program foundation into the company's operations enhances the ability of the Compliance Program to grow with the company.

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Key components of the Compliance Program Foundation include:

  • Compliance Program Charter
  • Code of Conduct
  • Compliance Committee Charter and establishment
  • Compliance Officer appointment and job description
  • Non-Retaliation Policy
  • Sanction Screening Policy​

A Cost-Effective Approach to Compliance 

Resources

Medical Device and Pharmaceutical Manufacturers

Phase 4 - Compliance Due Diligence Consulting

Now that you have built the success of your company to be attractive to acquiring companies, you need to prepare for due diligence.  In the medical device and pharmaceutical industry, many of the larger companies have endured federal investigations, settlements, and in some cases, criminal convictions.  Those acquiring companies will ask difficult questions about the Compliance Program.  Preparation and experience can help ensure that the due diligence process does not derail the acquisition.  JD HealthCare Partners, LLC has the experience to successfully lead you through the compliance due diligence process on the path to acquisition.

Most small and start-up medical device and pharmaceutical manufacturers do not have the resources to invest in a robust Compliance Department.  Unfortunately, ignoring the compliance program will inevitably result in significantly higher costs later.  JD HealthCare Partners, LLC has developed a cost-effective solution for small and start-up device and pharmaceutical companies to build and operate effective Compliance Programs based on the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Department of Health and Human Services Office of Inspector General over 4 progressive phases.​