WHAT GETS SHIPPED
Three pillars of the medical device practice.
DEVICE MECHANICAL DESIGN
Housings, interfaces, and instrument geometry
We take external device hardware from concept CAD through a release package a supplier can build from without a phone call. Wall thickness, draft, ribs and bosses, parting strategy, and tolerance stack-up get resolved against the molder’s constraints before tool release, not after. Drawings come out toleranced to ASME Y14.5 in your title block, revision controlled, ready for your PLM vault or a supplier RFQ.
SIMULATION AND PROTOTYPES
Evidence before you commit to tooling
Structural, thermal, durability, and material selection analysis carries the same reporting standard as our automotive and defense work. Deliverables are engineering reports with methodology, assumptions, results, and margin summaries, not just images. Prototypes come off our own Auburn Hills floor, which means a fit problem found on Tuesday is a revised print on Wednesday instead of a two-week loop through a vendor queue.
RECORDS AND HANDOFF
Engineering evidence your quality system can use
Buyers usually ask for this as design history file inputs. We produce the engineering half: requirements-linked drawings, analysis reports, design review records, verification results against your written specifications, revision history, and first-article dimensional reports. Your quality and regulatory team owns the file, the design controls, and the submission. We build the evidence that goes in it and keep it traceable enough that nobody has to reconstruct it later.
HOW A PROGRAM RUNS
Four steps from brief to release.
NDA and scope
Mutual NDA before substantive disclosure, then a written scope that names the device, the approved mechanical inputs, the deliverables, the CAD platform, and the boundary. Implant scope, electrical work, and regulatory ownership are ruled out in writing here, not discovered later. You own everything we produce.
Concepts and DFM
Concept CAD with manufacturability constraints applied from the first sketch. Material candidates, moldability, assembly sequence, service access, and tolerance strategy are argued out on screen and in a documented design review while changes still cost hours rather than tool steel.
Analysis and prototype
Structural, thermal, and durability analysis against your load cases, Moldflow on molded parts, then physical hardware from our Auburn Hills prototype floor. Findings loop straight back into the model because the engineer and the machine are in the same building.
Release and evidence
Toleranced drawings in your title block, assembly documentation with BOM, verification reports, and first-article dimensional records. Native CAD released to you, and the package handed to your supplier or ours in a form they can build from.
THE SCOPE LINE
External devices only. Not ISO 13485.
ADAPT is a mechanical engineering practice, and on medical programs that scope line matters more than it does anywhere else on this site. We engineer external devices and surgical instruments: handheld and bedside hardware, housings and enclosures, mechanical interfaces that meet skin or a hospital rail, non-electrical wearable structures, external diagnostic tools and fixtures, and non-implantable mechanical delivery devices. We do not engineer implants. No spinal hardware, no orthopedic plates or screws, no dental implants, nothing intended to remain inside the body.
Our scope is mechanical only. No electrical, no PCB, no firmware, no software as a product. If your device has a board in it, we design the structure around the board and coordinate with whoever owns the electronics, and we say so in the quote rather than after kickoff.
The work itself is what a Tier 1 program looks like applied to a device housing. Concept CAD in the platform your supply chain requires, structural and thermal FEA, certified Moldflow for flow, pack, cooling, and warpage before a tool is cut, drawings toleranced to ASME Y14.5 with a datum strategy an inspector can actually use, prototypes on our Auburn Hills floor in FDM, SLA, SLS, cast urethane and silicone from RTV tooling, or CNC, and dimensional records off a FaroArm or CMM when a first article needs to be proven rather than asserted. WarriorNP is a documented ADAPT customer in this space, working with us since 2022 on external neonatal and pediatric tools including the ArcAngel endotracheal tube holder.
On regulatory work we are deliberately narrow. ADAPT is ISO 9001:2015 certified. We are not ISO 13485 certified, we are not a regulatory consultancy, and we do not prepare, sign, own, or file a 510(k). What we produce is engineering evidence for your quality system: requirements-linked drawings, calculations, design review records, verification reports against your written specifications, revision history, and dimensional results. Your team owns intended use, risk management, design controls, validation, and every submission. Electrical safety, EMC, and biocompatibility testing go to qualified labs and CROs, and we coordinate with them rather than claiming their scope.
We turn down implant work every year, and we decline regulatory ownership just as often. Both answers protect you. Buy mechanical engineering from us, and buy your quality system and submission strategy from people who do that for a living. If procurement requires an ISO 13485 certified design supplier, we are not your fit, and you should know that before the RFQ.
Brian Smith, Director of Engineering
FREQUENTLY ASKED
Questions and answers
Does ADAPT design implantable medical devices?
No. Our medical scope is external devices and surgical instruments. We do not engineer implants of any kind, including spinal hardware, orthopedic plates and screws, dental implants, pacemakers, stents, drug-eluting devices, contact lenses, or anything intended to remain inside the body. That work demands a quality system, biocompatibility program, and regulatory apparatus we do not operate. External housings, mechanical interfaces, non-electrical wearable structures, external diagnostic tools, fixtures, and instrument geometry are all in scope.
Is ADAPT ISO 13485 certified?
No. ADAPT is ISO 9001:2015 certified and performs mechanical engineering under that quality system. ISO 13485:2016 is the medical-device-specific quality management standard, and it carries obligations around regulatory requirements, risk, and process validation that ISO 9001 does not. Holding ISO 9001:2015 does not replace a medical-device-specific supplier requirement. If your procurement process requires an ISO 13485 certified design supplier, we are not the right fit, and we would rather tell you on this page than three weeks into an RFQ.
Can ADAPT prepare a 510(k) or perform IEC 60601 testing?
No to both. We do not prepare, sign, own, or file a 510(k), we do not provide FDA or EU regulatory consulting, and we do not guarantee an approval. The submitter holds legal authority over the device, and that stays with you. We also do not design electrical systems or perform IEC 60601, EMC, or electrical safety testing. What we provide is the mechanical engineering that supports your work: toleranced drawings, analysis reports, design review records, verification results against your specifications, revision history, and dimensional evidence. Regulatory strategy and agency interaction belong with your team or a qualified regulatory consultancy.
Can an outside engineering firm produce design history file inputs?
Yes, as inputs. Buyers still say DHF and we know what they mean. We generate requirements-linked drawings, calculations, design review records, verification reports against your written specifications, revision history, and dimensional results in a form your quality system can absorb. You own the record, the design controls, the validation, and the submission. We do not operate your quality system, and we do not perform IEC 60601 testing, sterilization validation, or biocompatibility certification.
TALK TO AN ENGINEER
Tell us what you are building.
Send the program brief. An engineer on our team will read it and respond within one business day. Not a sales coordinator. Not a routing form.