Medical Devices and Diagnostics

Almost no other regulated industry sector has experienced the regulatory innovation and change found in today’s medical device and diagnostic sectors. From EU MDR and FDA’s stated ISO 13485 alignment to MDSAP, GUDID, cybersecurity, and VSMR, the medical device and diagnostic sector is dealing with accelerating product innovation, digital convergence, and a rapidly evolving, globally aligned regulatory landscape.  For companies that play a crucial role in addressing patient disorders, providing quality treatment options, and improving patient outcomes, this confluence of challenges often necessitates expert help and assistance from innovators and problem solvers. 

Our expert consulting leadership team has experience from the plant-floor to the C-Suite and have navigated some of the most complex issues for leading medical device and diagnostic companies. Risk Management for MD&D Manufacturers from the 2021 American Medical Device Summit 

When it comes to breadth and depth of experience in FDA-regulated industries, you will be hard-pressed to find someone better equipped than John Daley.  In his 30-plus years in the industry, John has worked for companies that range from global behemoths with $60B sales to small tups that brought in $12MM/year.   

He has worked with all classes of devices in both the US and globally.  He has meaningful, direct experience in combination products, In-vitro Diagnostics, and pharmaceuticals.  He has been on the leadership teams that resolved probation agreements and corporate warning letters. 

As evidenced by his extensive management board experience with Johnson & Johnson, Boston Scientific, and IBM, he has delivered value and grown as a leader. 

John has done this by remaining perpetually curious, holding himself and others to a high standard of excellence, and seeking out, attracting, and retaining great people. 

John is that person if you need someone who can come, fly the plane, and then swap out the engine. 

Pedro A. Martínez Rivera, a native of Juana Díaz, Puerto Rico, embarked on a remarkable journey that spanned various industries and educational pursuits. Here is a concise summary of his impressive career and accomplishments:

• Chemical Engineering: Pedro attended Clarkson University, earning a bachelor’s degree in chemical engineering.
• Pharmaceutical Industry: He joined the chemical industry, gaining experience in Process Development, Quality, and Manufacturing. Later, he transitioned to the Pharmaceutical Industry, overseeing facilities specializing in active pharmaceutical ingredients.
• Medical Devices: Pedro entered the medical device arena, actively contributing to developing and commercializing minimally invasive surgical technologies.
• International Business Operations: He drove innovative solutions in Interventional Cardiology, Orthopedics, General Surgery, ENT, and Gynecology.
• Global Manufacturing: Pedro established the first global manufacturing facility for the commercially sold Drug-Eluting Stent.
• Management Consulting: He was part of the Gallup Management Organization, specializing in Employee Selection, Organizational Engagement, and Customer Retention.
• Education: Pedro pursued further education, completing an MBA in Management from Universidad del Turabo, an MS in Finance from Baruch College-Zicklin School of Business, and advanced executive programs at Northwestern University Kellogg School of Business, and Purdue University – Krannert School of Management.
• Certifications: He is a Registered Professional Engineer and a Johnson & Johnson Certified Black Belt¹.

Teresa Gorecki is VP and Practice Lead at Compliance Architects LLC, with over 30 years of experience in Quality Assurance across various sectors, including medical devices, biopharma, pharma, and consumer products. She has held senior executive roles at Johnson & Johnson for 15 years and has been a Quality Consultant for eight years. Teresa has led the FDA approval of numerous products, including monoclonal antibodies, r-DNA products, and complex combination products.

As a consultant, she has expanded her expertise to include RadioPharmaceuticals and Companion Diagnostics, applying regulations to novel products. She supports virtual start-ups in BioPharma, helping them navigate from pre-clinical to FDA/global approvals. Teresa has developed a risk-based approach to creating phase-appropriate quality management systems for clinical development.

She is also experienced in managing FDA inspections, preparing 483 and Warning Letter responses, and developing strategies to prevent regulatory actions. Teresa emphasizes thorough, risk-based, and transparent communication with the FDA to maintain compliance.