Agent skill

Device Diligence

by hh-health-AI in hh-health-AI/healthcare-equity

This skill should be used when the user asks about "510(k) predicate risk", "De Novo vs PMA pathway", "FDA meeting history for [asset]", "TPP assessment", "CMC/manufacturing scalability", "freedom…

MITAuto-check passedLegal & Compliance

Install Device Diligence

skills CLI
$ npx skills add hh-health-AI/healthcare-equity --skill device-diligence -a claude-code

Project install by default; add -g for ~/.claude/skills/.

GitHub CLI
$ gh skill install hh-health-AI/healthcare-equity device-diligence --agent claude-code

Project scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).

Manual copy
$ git clone --depth 1 https://github.com/hh-health-AI/healthcare-equity.git skills-src && mkdir -p .claude/skills && cp -r skills-src/modules/clinical-catalysts/skills/device-diligence .claude/skills/device-diligence && rm -rf skills-src

Use ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.

Claude Code skills documentation · loads skills from .claude/skills/

Facts

Skill name
device-diligence
GitHub stars
101
Token cost
~1k tokens
SKILL.md length
426 words
Files
2 (incl. references)
Skills in repo
72
Repo updated
First seen
Licence
MIT

At a glance

This skill should be used when the user asks about "510(k) predicate risk", "De Novo vs PMA pathway", "FDA meeting history for [asset]", "TPP assessment", "CMC/manufacturing scalability", "freedom…

  • Works in 4 steps: Choose the workflow(s) from the table,… → Ground pathway and development-stage… → For legal-adjacent outputs (FTO), state… → …
  • Asks about 510(k) predicate risk
  • SKILL.md covers Execution rules and Combination products &…
  • Instructions only: no scripts, shell commands, URLs or credentials in SKILL.md

What it does

Device Diligence is an agent skill from hh-health-AI/healthcare-equity. This skill should be used when the user asks about "510(k) predicate risk", "De Novo vs PMA pathway", "FDA meeting history for [asset]", "TPP assessment", "CMC/manufacturing scalability", "freedom to operate / IP risk", "LDT rule impact", or "companion diagnostic linkage" — the regulatory and technical diligence layer for drugs, devices, and diagnostics.

Its SKILL.md is about 1k tokens, which your agent loads only when the skill is triggered. The skill folder holds 2 other files, including reference files (for example `references/prompts.md`).

It sits in Legal & Compliance, covering Intellectual property. The repository describes itself as: Synthesis engine for buy-side healthcare equity research. The licence is MIT.

When your agent uses it

  • Asks about 510(k) predicate risk
  • De Novo vs PMA pathway
  • FDA meeting history for [asset]
  • CMC/manufacturing scalability

Example prompts

  • “510(k) predicate risk”
  • “De Novo vs PMA pathway”
  • “FDA meeting history for [asset]”
  • “/device-diligence”

Workflow steps

4 steps, taken from the first numbered list in SKILL.md.

  1. Choose the workflow(s) from the table, load the prompt, and gather primary sources first: FDA databases via web research (Drugs@FDA…
  2. Ground pathway and development-stage judgments in ${CLAUDE_PLUGIN_ROOT}/references/fda-pathways-fto.md and…
  3. For legal-adjacent outputs (FTO), state the analysis is an investment-diligence screen, not a legal opinion, and note that definitive FTO…
  4. End each workflow with the EVIDENCE BRIEF block (layer: regulatory; competitive for TPP/CDx where share-relevant). Route label/coverage…

What it can do on your machine

Read from SKILL.md and the folder at commit 6c7bda8. It shows what the files ask for, not the result of running them.

  • Tool permissions

    Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.

    From allowed-tools in the SKILL.md frontmatter.

  • Runs code

    No scripts in the folder and no shell commands in SKILL.md.

    From the folder's file list and the shell code blocks in SKILL.md.

  • Network

    No URLs in SKILL.md.

    From URLs in SKILL.md, links to its own repository left out.

  • Credentials

    Names no API keys, tokens, secrets or passwords.

    From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.

Context cost

Device Diligence loads about 1k tokens when it runs, and up to ~2.6k if it reads all its reference files. Until then it costs about 93 tokens; SKILL.md has 426 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it
~93
When it runs · the whole SKILL.md, loaded when a task matches
~1k
With references · SKILL.md plus every file in references/, read only if the agent opens them
~2.6k

Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.

Safety

Auto-check passed

The automated check found no risky patterns in SKILL.md.

Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); files beside SKILL.md are not scanned.

SKILL.md

The full file from hh-health-AI/healthcare-equity at commit 6c7bda8, republished under its MIT licence (© hh-health-AI). 426 words, ~1,032 tokens.

Download SKILL.mdSave it as .claude/skills/device-diligence/SKILL.md (or your agent's skills folder). This skill also uses 1 other file; get the full folder from GitHub.
name
device-diligence
description
This skill should be used when the user asks about "510(k) predicate risk", "De Novo vs PMA pathway", "FDA meeting history for [asset]", "TPP assessment", "CMC/manufacturing scalability", "freedom to operate / IP risk", "LDT rule impact", or "companion diagnostic linkage" — the regulatory and technical diligence layer for drugs, devices, and diagnostics.
metadata.version
0.1.0

Device & Regulatory Diligence

Deep regulatory and technical diligence: product profile, manufacturing, IP, FDA pathway and history, diagnostics regulation, and therapy–test coupling. Eight workflows, each a prompt in ${CLAUDE_PLUGIN_ROOT}/skills/device-diligence/references/prompts.md — pick by question:

QuestionPromptPrimary sources
Is the product profile differentiated or me-too?SUB-BIO-04 (TPP interrogation)Corporate deck, protocol, comparator labels
Can they make it at scale, at margin?SUB-BIO-05 (CMC/COGS scalability)Filings, manufacturing disclosures, CDMO contracts
Is the IP position durable?SUB-BIO-06 (FTO analysis)Patent databases, Orange/Purple Book, Para IV notices
What does the FDA interaction history signal?SUB-BIO-07 (meeting history risk)SEC filings, Drugs@FDA, correspondence disclosures
Is the 510(k) predicate sound?SUB-MED-03 (predicate validity)FDA 510(k) database, classification regs
De Novo or PMA — and what does the pathway cost?SUB-MED-04 (pathway risk)FDA classification, recent comparables
What does the LDT rule do to this diagnostic?SUB-TLS-03 (LDT oversight impact)FDA LDT final rule, company disclosures, litigation status
Does a companion diagnostic gate the therapy?SUB-TLS-05 (CDx linkage)Drugs@FDA labels, CDx approvals, guidelines
Does a delivery-format change (IV→SC, autoinjector, PFS) carry the thesis?Combination-product module (below)FDA combination-product precedents, ISO 11608, DMEPA/URRA records

Execution rules

  1. Choose the workflow(s) from the table, load the prompt, and gather primary sources first: FDA databases via web research (Drugs@FDA, 510(k)/PMA/De Novo databases, warning letters), the Clinical Trials connector for supporting studies, PubMed for published validation data.
  2. Ground pathway and development-stage judgments in ${CLAUDE_PLUGIN_ROOT}/references/fda-pathways-fto.md and ${CLAUDE_PLUGIN_ROOT}/references/device-development-checkpoints.md (includes the human-factors gate). For drug CMC, translate per the manufacturing row of references/evidence-translation-clinical.md: CMC progress moves launch probability, timing, yield, capacity, and capital — not patient demand or share.
  3. For legal-adjacent outputs (FTO), state the analysis is an investment-diligence screen, not a legal opinion, and note that definitive FTO requires patent counsel.
  4. End each workflow with the EVIDENCE BRIEF block (layer: regulatory; competitive for TPP/CDx where share-relevant). Route label/coverage consequences to adcom-label and cms-reimbursement; route pathway timelines to catalyst-calendar; route COGS/margin deltas to healthcare-equity model-valuation.
Show full SKILL.md (106 more words)Show less

Combination products & delivery-format changes

For IV→SC conversions, autoinjector/PFS launches, self-administration claims, and device changes on marketed drugs, work from ${CLAUDE_PLUGIN_ROOT}/references/combination-products.md: place the change on the four-domain evidence ladder (HF/URRA · PK bridging 80–125% · clinical · CMC/EDDO, with the Humira-s381 → Repatha precedent range), check device qualification (ISO 11608, aged/shipped verification, PPQ at filing) and the autoinjector deficiency base rates (~10/12 recent BLAs flagged on essential-performance traceability), note that shelf-life/device-change supplements are PAS-clocked dated events, and translate per the "easier administration" evidence row — a format conversion moves initiation/site-of-care/persistence, never efficacy or TAM, and is not a new patient (case C05 rule). Post-launch, hand MAUDE use-error trajectories to the quality-signals skill.

© hh-health-AI, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file

Files

SKILL.md and 1 other file (references) in modules/clinical-catalysts/skills/device-diligence of hh-health-AI/healthcare-equity.

  • SKILL.md
  • references/prompts.md

Open the folder on GitHubat commit 6c7bda8

Compare with similar skills

Device Diligence next to the 5 skills that share the most tags, products or categories with it. Stars are the repository's; “used in” counts other GitHub owners with a copy.

Device Diligence compared with similar skills
SkillStarsUsed inTokensAuto-checkLicenceRepo updated
Device Diligence this skillhh-health-AI/healthcare-equity101—~1kAutomated safety check: PassMIT
Paper to Chinese Patent DrafterYuan1z0825/nature-skills47k1 repos~1.1kAutomated safety check: PassApache-2.0
Paper To Cn Patentsnipp-zha/Paper-to-patent-Skill1071 repos~959Automated safety check: PassNone
Patent Examinegfodor/legal-skills393—~4.8kAutomated safety check: PassGPL-3.0
Patent Auditgfodor/legal-skills393—~2.9kAutomated safety check: PassGPL-3.0
Replica BrandJakeschincariol/replica-skill1.4k—~1.1kAutomated safety check: PassMIT

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Questions about Device Diligence

What does Device Diligence do?

This skill should be used when the user asks about "510(k) predicate risk", "De Novo vs PMA pathway", "FDA meeting history for [asset]", "TPP assessment", "CMC/manufacturing scalability", "freedom…. Device Diligence is an agent skill from hh-health-AI/healthcare-equity. This skill should be used when the user asks about "510(k) predicate risk", "De Novo vs PMA pathway", "FDA meeting history for [asset]", "TPP assessment", "CMC/manufacturing scalability", "freedom to operate / IP risk", "LDT rule impact", or "companion diagnostic linkage" — the regulatory and technical diligence layer for drugs, devices, and diagnostics.

When should I use Device Diligence?

Device Diligence fits situations like: asks about 510(k) predicate risk; de Novo vs PMA pathway; FDA meeting history for [asset]; CMC/manufacturing scalability.

How do I install Device Diligence in Claude Code?

Run `npx skills add hh-health-AI/healthcare-equity --skill device-diligence -a claude-code`. Or copy the skill folder (modules/clinical-catalysts/skills/device-diligence in hh-health-AI/healthcare-equity) into .claude/skills/device-diligence in your project. Claude Code loads it when a task matches its description.

How do I install Device Diligence in Codex?

Run `npx skills add hh-health-AI/healthcare-equity --skill device-diligence -a codex`. Or copy the skill folder (modules/clinical-catalysts/skills/device-diligence in hh-health-AI/healthcare-equity) into .agents/skills/device-diligence in your project. Codex loads it when a task matches its description.

Can I use Device Diligence in Cursor, Gemini CLI or GitHub Copilot?

Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add hh-health-AI/healthcare-equity --skill device-diligence -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/device-diligence, .gemini/skills/device-diligence, .github/skills/device-diligence and .opencode/skills/device-diligence in your project.

What does Device Diligence need to run?

SKILL.md names no scripts, command-line tools or credentials: Device Diligence is instructions for the agent only.

Does Device Diligence access the network?

SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.

Is Device Diligence safe to install?

Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. Review the folder before installing.

What licence does Device Diligence use?

Device Diligence is published under the MIT licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.

How many tokens does Device Diligence use?

About 1k tokens (SKILL.md is roughly 4.1k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 1.6k tokens, read only when the agent opens those files.

What are the alternatives to Device Diligence?

Skills that share tags, products or a category with Device Diligence: Paper to Chinese Patent Drafter (Yuan1z0825/nature-skills, 47k stars), Paper To Cn Patent (snipp-zha/Paper-to-patent-Skill, 107 stars), Patent Examine (gfodor/legal-skills, 393 stars) and Patent Audit (gfodor/legal-skills, 393 stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.

Who maintains Device Diligence?

hh-health-AI (a GitHub user) maintains it in hh-health-AI/healthcare-equity, which has 101 GitHub stars. The repository holds 72 skills in this directory. The repository was last updated on October 8, 2026.

Source: hh-health-AI/healthcare-equity on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.