Statistical consulting · Medical device & pharmaceutical
Confidence,
Quantified.
M-D Stats helps device and drug manufacturers turn product and process data into defensible, regulator-ready evidence — across design of experiments, process validation, control, capability, and reliability.
Trusted for the statistics behind
- Design verification & validation
- Manufacturing & process control
- Quality & regulatory submissions
- Reliability & shelf-life
What we do
The right statistical method, applied to the data your product and process generate.
From a first prototype run to a validated production line, your data holds the answers to questions your teams have to defend: Is the process capable? Are the specifications met? How much testing is enough? M-D Stats brings the statistical rigor to answer them clearly.
We partner with R&D, quality, manufacturing, and regulatory teams to design sound studies, analyze the resulting data, and document conclusions that withstand scrutiny — translating statistics into decisions you can stand behind.
See how we workServices
Statistical support across the product & process lifecycle
Focused capabilities for the questions medical device and pharmaceutical manufacturers face on the bench and the production floor.
Why M-D Stats
Rigor you can defend, delivered by someone who has been there
Regulator-ready by design
Every method is chosen and documented so it holds up in audits and submissions — clear assumptions, justified sample sizes, and a rationale reviewers can follow.
Senior attention, start to finish
You work directly with the statistician doing the analysis — not a hand-off chain. Fewer misunderstandings, faster answers, and advice grounded in your context.
Engineering fluency
A background in mechanical engineering means the statistics connect to real manufacturing: tolerances, gauges, fixtures, and the way processes actually behave.
Focused scope
We concentrate exclusively on product and process data. That focus means deep, current expertise in exactly the problems device and drug manufacturers face on the floor.
How we work
A clear path from question to evidence
- 01
Frame the question
We clarify the decision behind the data, the risks involved, and the evidence a reviewer will expect — before any analysis begins.
- 02
Design & analyze
We choose the right method, size the study, and run the analysis — checking assumptions and pressure-testing the conclusions along the way.
- 03
Deliver defensible evidence
You receive clear results, plain-language interpretation, and documented rationale your quality and regulatory teams can put straight to work.
The principal
David Plescia
Principal Statistician · Member, American Statistical Association
M-D Stats is led by David Plescia, who brings more than two decades of experience applying statistics to real medical device and pharmaceutical manufacturing problems. An engineer by training, he pairs statistical depth with a practical understanding of how products are made and measured — so the analysis fits the shop floor, not just the textbook.
Start a conversation
Have a data question you need answered with confidence?
Bring your product or process data challenge. In a short introductory call we’ll scope the statistical approach and the evidence you’ll need.