Digital Health Solutions & Medical Device Statistics

Medical device & digital health development requires rigorous statistical analysis to meet regulatory standards and ensure patient safety.

As a specialized medical device statistics consultant, I help you navigate the complex regulatory landscape from pre-clinical validation through post-market surveillance.

Whether you’re preparing FDA submissions, conducting clinical trials, or implementing post-market studies, my expertise ensures your statistical approaches meet the highest regulatory and scientific standards.

Comprehensive Medical Device Statistics Services

Transform your device data into compelling regulatory submissions and clinical evidence.

My end-to-end medical device statistics services help manufacturers, researchers, and regulatory teams build robust statistical foundations for successful device approvals and market success.

Study Design & Regulatory Planning

Build statistical frameworks that align with FDA expectations and international standards.

  • Design IDE studies and pivotal clinical trials with appropriate statistical power
  • Develop 510(k) predicate device comparison strategies and equivalence testing
  • Create PMA study protocols with regulatory-compliant statistical analysis plans
  • Plan Predetermined Change Control Plans (PCCPs) with appropriate statistical monitoring
  • Design post-market surveillance studies for ongoing safety monitoring
  • Establish clinical evaluation frameworks for combination devices

FDA Submission Statistics

Prepare statistical sections that meet regulatory requirements and support approval.

  • Generate 510(k) statistical summaries demonstrating substantial equivalence
  • Develop comprehensive PMA statistical analyses with clinical and non-clinical data
  • Create IDE study reports with interim analysis and safety monitoring plans
  • Prepare De Novo pathway statistical documentation for novel device classifications
  • Develop statistical sections for 513(g) requests and pre-submission meetings
  • Document statistical methodologies for regulatory correspondence and responses

Clinical Trial Implementation

Execute device trials with statistical rigor and regulatory compliance.

  • Implement adaptive trial designs with appropriate statistical monitoring
  • Conduct interim analyses with pre-specified stopping rules and efficacy boundaries
  • Perform safety analyses including adverse event reporting and risk assessment
  • Execute non-inferiority and superiority testing for device comparisons
  • Analyze multi-center trial data accounting for site effects and patient clustering
  • Handle missing data and dropout patterns specific to device trial challenges

Specialized Device Categories

Tailored statistical approaches for complex device types and emerging technologies.

  • AI-powered medical devices: Algorithm validation and performance assessment
  • Combination devices: Integrated statistical analysis of device and drug components
  • Cybersecurity validation: Statistical testing of device security and data integrity
  • Software as Medical Device (SaMD): Clinical evaluation and algorithm validation
  • Digital therapeutics: Efficacy measurement and user engagement analysis
  • Implantable devices: Long-term safety and performance monitoring

Post-Market Analytics

Ongoing statistical monitoring to ensure continued device safety and effectiveness.

  • Real-world evidence studies using claims data and electronic health records
  • Post-market surveillance statistical plans and periodic safety updates
  • Medical Device Reporting (MDR) statistical analysis and trend identification
  • Comparative effectiveness research using observational data
  • Device registry statistical analysis and long-term outcome assessment
  • Risk-benefit analysis updates based on post-market data

Regulatory Support

Beyond initial analysis, I provide comprehensive regulatory statistical support.

  • Statistical review of manufacturing quality control data
  • Design of experiments for device optimization and process validation
  • Biocompatibility and shelf-life statistical testing protocols
  • Statistical training for regulatory teams on device-specific requirements
  • Expert testimony and regulatory meeting preparation
  • Statistical responses to FDA questions and information requests
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Why Work With Me For Your Medical Device Statistics Needs?

Working with a medical device statistics expert benefits you in multiple ways.

Time Efficiency

Focus on device development while I handle complex regulatory statistics requirements.

Reduced Stress

Navigate FDA submissions and clinical trials with confidence in your statistical approach.

Regulatory Compliance

Use proven statistical methods that align with FDA guidance and international standards.

Successful Submissions

Increase approval probability with statistics that clearly demonstrate safety and efficacy.

The Medical Device Statistics Process

My consulting process is designed for regulatory success and scientific rigor.

Discovery Phase

We connect to understand your device, regulatory pathway, data availability, and timeline requirements for submission or clinical studies.

Statistical Plan Development

Together, we establish the statistical approach, including study design, analysis methods, and regulatory strategy. All details are documented in a formal Service Proposal.

Analysis and Implementation

I execute your statistical analysis with precision, handling complex issues like multi-endpoint studies, adaptive designs, and regulatory compliance requirements.

Deliverables

I provide comprehensive statistical reports, regulatory submission sections, and publication-ready analyses that meet FDA standards and support your business objectives.

For urgent questions, my on-demand consultation service offers quick, cost-saving solutions.

Book Express Consultation

Case Studies

I worked on large medical datasets to answer causal questions related to epidemiological determinants of disease through complex exposures. Challenges included selection bias, confounding, and missing data. I successfully developed a strategy that gave researchers confidence in their results.
I’ve worked with R&D scientists who were simultaneously running multiple experiments to answer important questions about their cutting-edge products that would have a direct impact on various stakeholders. My role was to help in designing and analyzing the experiments, balancing the conceptual purity of the Design of Experiments theory (DoE) with pragmatic concerns relating to costs and timeline. Most of this work is sealed behind a Non-Disclosure Agreement (NDA) which prevents me from elaborating more.

Don’t Just Take My Word For It…

The positive experiences of my happy collaborators showcased through their glowing testimonials, serve as powerful proof of trustworthiness and the impact of the results I deliver. These testimonials offer real-life examples of how I’ve helped research projects succeed. Here are some of their thoughts:

5/5

"He has a deep understanding of statistics, yet is able to skillfully explain complex concepts to people with little-to-no background in statistics both in French and English."

Elsa Brunet-Ratnasginham

Post-doc, UCSF

5/5

"I had never before worked with a biostatistician who speaks the same language as me! [...] Personally, our collaboration has allowed me to reconcile with statistics."

Manon Nayrac

Post-doc, CRCHUM

5/5

"I highly recommend Justin and his team for your data processing needs in order to have a more robust statistical model than the tests we are accustomed to conducting as biologists!"

Gérémy Sannier

Ph.D candidate, CRCHUM

5/5

"Thanks to him, statistics appeared to me as solutions rather than obstacles."

Mathieu Dubé

Research Associate, CRCHUM

Read Full Collaborator Testimonials
Justin Belair - Causal Inference Expert

My Statistics and Causal Inference Expertise

As a university-level statistics lecturer with a substantial LinkedIn following, scientists from all over the world come to me for my unique combination of academic excellence and practical experience in statistics and causal inference.

I’ve applied causal inference methods in varied settings in both academia and industry: in biomedical sciences such as nephrology, immunology, neuroscience, virology, occupational therapy, epidemiology, dermatology, psychiatry, and oncology; in natural sciences such as agronomy, ecology, and zoology; and social sciences such as communication, and psychology. The list keeps on growing!

I am currently writing an advanced textbook that I hope will give a young generation of academic and industry researches the tools needed to grapple with the complexities of causal inference, and maybe even develop a passion for the subject!

Need help with medical device statistics? From regulatory guidance to complex clinical trial analyses, I offer expertise and collaboration to maximize your device development success.

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Tools and Technologies

Statistical Software Excellence

Using industry-standard software like R, SAS, and Python, along with specialized medical device analysis packages, I ensure your statistical analyses meet the highest regulatory standards.

Regulatory Compliance Systems

I leverage advanced statistical computing environments designed for FDA submissions, including validated software systems and documented analysis workflows that support regulatory inspection.

Clinical Trial Management

I integrate with clinical data management systems and electronic data capture platforms to ensure seamless statistical analysis of device trial data.

Client Industries Served

My statistical consulting expertise extends beyond specific industries, serving clients in fields ranging from R&D in biotechnology and pharmaceuticals to researchers and Principal Investigators (PI) in academia.