Who We Are.

Our experts are client-focused, trustworthy, compassionate, and strategically located across the globe to ensure maximum efficiency.  The consultants of HDH Solutions Group have years of practical experience navigating and applying complex medical device, IVD, pharmaceutical, biotech, and dietary supplements regulations, guidance, and standards.

The founder of HDH Solutions Group LLC, Heather brings 35+ years of experience educating stakeholders on medical product regulations. Leveraging her diverse background, Heather helps clients communicate effectively, achieve regulatory compliance, meet global competency requirements, and improve operational efficiency. 

With demonstrated success building high-performing diverse teams, Heather identifies the best qualified resources and right-sized solutions for your toughest regulatory challenges.  A consummate public health and safety advocate, she’s proficient in securing strategic partnerships, building strong relationships, and maximizing stakeholder engagement. 

Heather lives in the Washington, DC metro area and works globally. She holds a Bachelor of Science degree in Behavioral Science, and Master’s certificates in both Project Management and Organizational Leadership.

From 1989-2016, Heather enjoyed an impactful career with the US FDA, culminating with her role as a Deputy Office Director in the Center for Devices and Radiological Health (CDRH).  

With authority over industry education and risk communication, Heather ensured messaging was timely, promoted patient safety, and aligned with Agency policy. Her oversight included final clearance of all CDRH Safety Communications and more than 4000 webpages, multiple social media platforms, and a state-of-the-art broadcast television/video production facility. 

As CDRH Liaison with industry associations and patient/consumer groups, Heather developed robust outreach policies still in place today, such as CDRH Speaker Requests, Public Meetings, and External Expertise. 

Early career included leadership roles in the FDA Office of Regulatory Affairs/Northeast Region, FDA Office of the Commissioner/Office of Media Affairs, and CDRH Office of Device Evaluation.

From 2016-2023, Heather supported Health Sciences clients with NSF International, a premier public health organization that provides global Consulting, Training and Certification. Heather held executive-level positions and advised the C-suite and Board of Directors on global health sciences business and regulatory matters.  

As the Executive Vice President for Global Training Solutions, Heather grew an impressive client base and pioneered highly profitable instructor-led and digital training programs for the Medical Device, Pharma Biotech, Dietary Supplements and Cosmetics industries, offering competency-based regulatory compliance training programs to a broad global client-base. 

Experienced in crisis management, Heather was hand-selected in 2022 by the CEO to provide interim leadership and stabilize the global Health Sciences Division after the $85 million business was suddenly without critical leadership. As interim Vice President, Heather created a robust 5-year Strategic growth plan for the six global businesses, retained all key clients and technical experts, increased employee satisfaction by 28%, and onboarded a permanent VP.  

Before leaving NSF in late 2023, Heather drove the Health Sciences go-to-market and global growth strategies – establishing the first formal Sales program for Consulting and CRO services. She strategically recruited global sales and marketing resources,  introduced commercial KPIs, and implemented Salesforce across five global businesses.

• Chaired the MDIC Patient Communication Subcommittee and co-authored publications on effective patient communication. 
• Forged innovative FDA-Industry collaborations and co-authored the CDRH Safety Signal Escalation Guidance.  
• Championed novel FDA resources such as CDRH Learn, the CDRH Regulatory Webinar Series, and Experiential Learning Program.
• Served as FDA Mentoring Champion for nearly a decade.
• Commercialized NSF’s first B2B medical device training program, including digital offerings, a cloud LMS, and eCommerce. 
• Built first-of-a-kind e-Learning to meet competency requirements of the Medical Device Single Audit Program (MDSAP). 
• Transitioned NSF’s Health Sciences Training portfolio into a fully virtual classroom.
• Led a highly specialized, complex global consulting business through a financial crisis to achieve $85M profitable revenue.