Precision for Value Expands Health Economics and Outcomes Research Team

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Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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February 19, 2015, New York – Precision for Value (www.precisionforvalue.com), a Precision for Medicine Company, which provides health economics, analytics, and marketing communications services to life sciences clients, today announced the expansion of its Health Economics and Outcomes Research (HEOR) Team to meet growing customer demand. Dr. Bob Nordyke was appointed as senior vice president, Health Economics and Evidence Strategy, Phil Cyr was named vice president, health economics and, Ellynne Dec was named senior principal, health economics.

“The fusing of health economics, market analytics, and strategic communication under the brand of Precision for Value is pointed squarely at where the market is headed,” said Dan Renick, president of Precision for Value. “Commercial clients are increasingly realizing that demonstrating and communicating value will be the challenge that separates winners from losers in the marketplace and that they need solutions that are faster, flexible, and innovative. We’re thrilled to add world-class HEOR experts like Bob, Phil, and Ellynne to our growing team, and confident their capabilities will further help our clients achieve commercial excellence through value demonstration that addresses unmet patient needs in the era of precision medicine.”

Dr. Bob Nordyke, PhD is responsible for delivering scientifically rigorous and commercially relevant services to global biopharma clients. Dr. Nordyke brings over 25 years of experience in health economics, outcomes research, and health policy experience. Dr. Nordyke has identified, built, and supported the economic value of biopharma products from the earliest stages of development to loss of exclusivity. Before joining Precision for Value, Dr. Nordyke established the health economics practice at PriceSpective and went on to lead the health economics practice following ICON Plc’s acquisition of PriceSpective and Oxford Outcomes. Prior to ICON, Dr. Nordyke was part of Amgen’s Global Health Economics team, where he served as the therapeutic area head for inflammation, the global payer lead and global health economics lead in oncology, and was the founding program lead for an EMR-based registry in oncology. Earlier he was the Director of Outcomes Research at Cerner LifeSciences, and a research fellow at the RAND Corporation.

Dr. Nordyke is an adjunct professor at the UCLA School of Public Health, formerly a lecturer at USC, and has authored or coauthored dozens of papers in leading journals such as the Journal of Managed Care Pharmacy, Value in Health and Social Science and Medicine. He received his Doctor of Philosophy from the RAND Graduate School and a Master’s from the University of Texas-Austin.

Phil Cyr is focused on developing and executing academically and commercially relevant health economic and outcome research studies and services for biopharma, medical device, and diagnostics clients. Mr. Cyr brings over 20 years of experience in health economics, outcomes research, health policy, and payer experience to Precision for Value. He offers practical knowledge of the global payer technology review process, having worked in technology assessment in the U.S. and Europe. Before joining Precision for Value, Mr. Cyr was Senior Director of Health Economics at PriceSpective and Icon Plc. where he drove the cross-function integration of the health economic practice across ICON’s Pricing and Market Access, Payer Engagement, and Peri-Approval practices. Prior to joining ICON, Mr. Cyr initiated and developed health economic practices for two healthcare consulting organizations, Navigant Consulting and Boston Healthcare Associates. Earlier in his career he held research and strategy positions at the Massachusetts General Hospital, Blue Cross and Blue Shield of Massachusetts, HCIA, Inc., and New England Medical Center.

Mr. Cyr has been an Adjunct Professor at the George Mason University School of Management and has coauthored numerous papers in leading journals such as American Journal of Health-System Pharmacy, Clinical Therapeutics, Cancer, and European Molecular Biology Organization (EMBO) Reports. He is also a peer reviewer for the American Journal of Managed Care. He received a Masters of Public Health, with concentrations in epidemiology and biostatistics, from the Boston University School of Public Health, and a Bachelor of Arts degree in biology and history from Kenyon College.

Ellynne Dec is a decision analyst and an actuary, and contributes over two decades of strategic economic advisory experience to Precision for Value. She contributes significant analytic and big data capabilities and international drug development experience to the team. Before joining Precision for Value, Ms. Dec was a healthcare actuary at Milliman, developing innovative cost impact and population health analyses using both real-world and clinical data sets. Prior to her work at Milliman, Ms. Dec was Director of Analytics and Operations at Novartis, and provided decision analytic support in a broad range of therapeutic areas and clinical operations. She also brings to Precision for Value over 10 years of experience in the United Kingdom, where she worked with the NHS, Department of Health, and other clients, building forecasting and valuation tools and developing cost impact analyses and “Green Book” appraisals.

Ms. Dec is an Adjunct Professor at both the Columbia University Business School and the Mailman School of Public Health. She has coauthored papers on cost and risk analysis, in publications including, most recently, American Health and Drug Benefits. She was a PhD candidate at Stanford University in Engineering Economic Systems, where she was a research assistant for Professor Ron Howard in the Decisions and Ethics Center. She is an Associate of the Society of Actuaries, and received a Bachelor of Arts degree in philosophy and logic at Smith College.

About Precision for Value

Precision for Value supports commercial excellence for global pharmaceutical and life sciences clients through the proficient demonstration of product value and outcomes. With locations in New York City, New Jersey, Chicago, Boston, Connecticut, and Indianapolis, Precision for Value’s teams provide clients with services grounded in decades of industry knowledge, demonstrated analytics proficiency, and marketing and communications prowess— making Precision for Value the preferred strategic partner in the industry. For more information visit www.precisionforvalue.com.

About Precision for Medicine

Precision for Medicine is a specialized company providing services and infrastructure to support life sciences companies as they develop new products in the age of precision medicine. Precision brings expertise, technology, and project execution to support innovative, patient-centric solutions from discovery through commercialization. The company is headquartered in Bethesda, MD. Visit www.precisionformedicine.com for more information.

# # #

Media Contact

Randy Zane

Precision for Medicine Media Relations

212-686-2650, ext. 3027

randy.zane@precisionformedicine.com

Randy Zane

Senior Director, Marketing Communications

Precision for Value

9 East 37th Street | New York, NY 10016

212 686 2650 office

212 686 2693 fax

A Precision for Medicine Company

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Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. 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