services
Medical Product Safety & Recall Advisory
Independent physician judgment when product safety, patient risk, FDA action, or legal strategy depends on what the medical evidence actually means.
THE PROBLEM
Where healthcare innovations lose their footing
When a medical product raises a potential safety concern, the critical question is not simply whether something went wrong, it is what the issue means clinically for patients.
RNB Ventures helps manufacturers, counsel, investors, and leadership teams evaluate clinical plausibility, severity and probability of harm, reversibility, vulnerable populations, detectability, continued-use risk, and the medical significance of complaints or failure modes, so consequential decisions are based on defensible medical judgment.
WHAT'S INCLUDED
How the engagement helps
HHE & Recall Advisory
Authoring or critical review of HHEs; patient-harm characterization; severity and probability; vulnerable populations; detectability and reversibility; continued-use versus removal risk; recall scope and medical rationale.
FDA Enforcement & Compliance
Physician review of medical-device reporting, complaint handling, CAPA, inspection findings, warning-letter issues, and the medical implications of product-impact investigations.
Transaction & Investment Diligence
Independent review of complaint trends, recall exposure, unresolved safety signals, clinical-evidence limitations, workflow risk, intended-use vulnerabilities, and management assumptions.
Product-Safety Investigations
Complaint and adverse-event review; medical chronology; safety-signal characterization; interview participation; and retrospective assessment of whether escalation and corrective action were proportionate.
Product-Liability Consulting
Non-testifying medical consulting addressing clinical plausibility, causation, warnings, alternative explanations, medical records, literature, opposing expert theories, and preparation of testifying experts.
AdPromo & Claims Substantiation
Medical and scientific review of express and implied claims, comparative or superiority statements, endpoints, risk balance, physician-facing materials, and alignment between clinical evidence and promotional messaging.
WHO IT'S FOR
Who this serves
Medical-device, diagnostic, pharmaceutical, and healthcare companies facing significant product-safety or regulatory questions. RNB Ventures also works with life-sciences attorneys and legal teams requiring independent physician judgment in matters involving HHEs, recalls, FDA interactions, investigations, product liability, or other questions where the clinical significance of a product issue is central to the decision.
Proof
Credentials behind the work
Robert N. Bilkovski, MD, MBA is a physician executive with experience in medical product safety, clinical risk assessment, and FDA-facing benefit-risk evaluation. Relevant experience includes authoring and critically reviewing Health Hazard Evaluations and medical product-risk assessments; prior physician consulting on multiple medical-device HHE matters for leading life-sciences counsel; medical assessment of severity, probability of harm, vulnerable populations, and benefit-risk; more than 30 clinical trials across pharmaceuticals, devices, and diagnostics; former medical leadership at Abbott, GE Healthcare, and Hospira/Pfizer; two consecutive years as a Regulatory Affairs Professionals Society (RAPS) annual-meeting panelist on medtech advertising and promotion; and experience in medical affairs, regulatory strategy, commercialization, claims review, and executive medical leadership.
QUESTIONS
Frequently asked
What is the role of a physician in a Health Hazard Evaluation?
An HHE requires more than a technical assessment of the failure. It requires medical judgment about clinical plausibility, severity, probability of harm, vulnerable populations, reversibility, detectability, and the consequences of continued use. My role is to make sure those conclusions are clinically grounded and defensible.
When should a manufacturer seek an independent medical review of an HHE?
Independent review is particularly valuable when the clinical consequences are uncertain, an HHE is weak or disputed, medical, quality, regulatory, and legal teams disagree, an FDA interaction is approaching, or a safety issue could materially affect recall, litigation, or diligence decisions.
Can you work directly with outside counsel?
Yes. RNB Ventures can work in a counsel-directed consulting role on HHEs, recalls, product-safety investigations, FDA matters, claims, diligence, and litigation-related medical questions. The consulting or testifying role should be defined clearly at the outset.
Do you provide support beyond recalls and HHEs?
Yes. The practice also includes product-safety investigations, FDA enforcement and compliance support, non-testifying product-liability consulting, transaction and investment diligence, and advertising, promotion, and claims substantiation.
Can you support urgent product-safety matters?
Product-safety issues are often time-sensitive. For appropriately scoped matters, RNB Ventures can provide expedited review when rapid medical judgment is required. Timing depends on the complexity of the issue, the amount of supporting information, and the specific deliverable required.