# Base Reality Group

> Dave Saunders is a Fractional CPO for product companies: software, SaaS, connected
> devices, medical devices and hard tech. He has taken 40+ products to market, including
> a surgical robot through FDA De Novo clearance. This site holds the engagement terms,
> a daily industry brief, and a set of free courses on the standards hard tech runs on.

Every page below is also available as markdown at the same URL with a .md extension.

## The practice

- [Base Reality Group — Dave Saunders | Fractional CPO for Product Companies](https://www.baserealitygroup.com/index.md): Fractional CPO for founders crossing the prototype-to-product gap. 40+ products commercialized, including FDA De Novo clearance for a surgical robot.
- [About — Dave Saunders](https://www.baserealitygroup.com/about.md): Thirty-five years getting new technology out of the lab and into the world. Bell Labs, the original Apple AirPort, and FDA De Novo clearance at Galen Robotics.
- [Work With Me — Dave Saunders](https://www.baserealitygroup.com/work-with-me.md): Two ways to engage: a paid one-hour working session with follow-up, or a six-month Fractional CPO engagement. Senior product leadership for founders.
- [The Fractional CPO Engagement — Terms](https://www.baserealitygroup.com/fractional-cpo.md): The six-month Fractional CPO engagement: one to two days a week inside your company, $10K to $25K a month, with a guarantee tied to your next real gate.
- [Plan to Market — A Six-Week Commercialization Cohort for Founders](https://www.baserealitygroup.com/plan-to-market.md): Six weeks, five founders, live. Leave board-ready and pitch-ready: a commercialization plan, a traction narrative, and the investor pitch built from them.
- [Books — Dave Saunders](https://www.baserealitygroup.com/books.md): Founders Who Finish and future titles by Dave Saunders: thirty-five years of product commercialization distilled into books for founders in the fight.
- [My Values for Helping Good Clients Win — Dave Saunders](https://www.baserealitygroup.com/values.md): A personal manifesto on how Dave Saunders approaches the work of helping founders build products and businesses that hold up, at any scale worth having.
- [Contact / Apply — Dave Saunders](https://www.baserealitygroup.com/contact.md): Apply to work with Dave Saunders. I work with a small number of companies at a time. Fill out the application and I'll be in touch if there's a fit.
- [Podcast Guest — Dave Saunders](https://www.baserealitygroup.com/podcast-guest.md): Invite Dave Saunders on your podcast. Author of Founders Who Finish and Fractional CPO for product companies. Episode topics, bios, and headshot.

## Operator's Guides

Free, ungated courses on the standards hard-tech products have to satisfy.

- [ISO 14971 Explained: A Free 12-Module Medical Device Risk Management Course](https://www.baserealitygroup.com/guides/iso-14971.md): A free 12-module video course on ISO 14971:2019 medical device risk management, taught by a 30-year operator. Builds a complete risk file on one worked device example.
- [Hazard, Hazardous Situation, and Harm: ISO 14971 Clause 3 Definitions](https://www.baserealitygroup.com/guides/iso-14971/hazard-hazardous-situation-harm.md): Hazard, hazardous situation, and harm are not synonyms. ISO 14971 Clause 3 definitions explained with a worked insulin pump example.
- [Hazard Identification with FMEA and FTA: ISO 14971 Risk Analysis Part 2](https://www.baserealitygroup.com/guides/iso-14971/hazard-identification-fmea-fta.md): FMEA alone will not satisfy ISO 14971. How to run FMEA and fault tree analysis together to find every hazard on a medical device.
- [Intended Use and Device Characteristics: ISO 14971 Risk Analysis Part 1](https://www.baserealitygroup.com/guides/iso-14971/intended-use-and-device-characteristics.md): Intended use, reasonably foreseeable misuse, and device characteristics: the three questions ISO 14971 risk analysis answers before any hazard hunting.
- [Overall Residual Risk Evaluation: ISO 14971 Clause 8](https://www.baserealitygroup.com/guides/iso-14971/overall-residual-risk.md): Every individual risk was acceptable. The whole device might not be. ISO 14971 Clause 8 overall residual risk evaluation, explained on a real device.
- [Post-Market Surveillance: ISO 14971 Clause 10](https://www.baserealitygroup.com/guides/iso-14971/post-market-surveillance.md): Risk management does not end at launch. ISO 14971 Clause 10 post-market surveillance: the five data sources, the action trigger, and the feedback loop.
- [Residual Risk and Benefit-Risk Analysis in ISO 14971](https://www.baserealitygroup.com/guides/iso-14971/residual-risk-benefit-risk.md): Residual risk done honestly: re-scoring after controls, building a benefit-risk case an auditor will accept, and knowing when a risk is worth shipping.
- [The Risk Control Hierarchy: ISO 14971 Clause 7](https://www.baserealitygroup.com/guides/iso-14971/risk-control-hierarchy.md): ISO 14971 gives medical devices their own three-tier risk control hierarchy in a mandatory order. Why you cannot lead with a warning label.
- [Risk Estimation with Severity and Probability: ISO 14971 Risk Analysis Part 3](https://www.baserealitygroup.com/guides/iso-14971/risk-estimation-severity-probability.md): How to score severity and probability honestly under ISO 14971, why your FMEA RPN is not your risk, and how to build the risk matrix.
- [Risk Evaluation and the Acceptability Line: ISO 14971 Clause 6](https://www.baserealitygroup.com/guides/iso-14971/risk-evaluation-acceptability.md): Risk evaluation is where a matrix color becomes a verdict. Drawing the ISO 14971 acceptability line, demonstrating ALARP, and handling the gray zone.
- [ISO 14971 Clause 4: The Risk Management Plan and System](https://www.baserealitygroup.com/guides/iso-14971/risk-management-plan-clause-4.md): ISO 14971 Clause 4 sets the plan, the policy, and the acceptability line before any analysis starts. How to set up the risk management system.
- [The Risk Management Report: ISO 14971 Clause 9](https://www.baserealitygroup.com/guides/iso-14971/risk-management-report.md): Your risk file is not your risk management report. What ISO 14971 Clause 9 requires, the seven elements of the report, and who has to sign it.
- [What Is ISO 14971? Why Medical Device Risk Management Exists](https://www.baserealitygroup.com/guides/iso-14971/what-is-iso-14971.md): What ISO 14971 is, why regulators require it, and the four definitions every medical device risk file is built on. Module 1 of a free 12-part series.

## Field Notes

One note per weekday on a real commercialization decision and what it cost.
Full archive: https://www.baserealitygroup.com/field-notes/archive — feed: https://www.baserealitygroup.com/rss.xml

- [GM Is Building Battery Cells It Will Never Sell So It Can Judge the Ones It Buys](https://www.baserealitygroup.com/field-notes/2026-09-13-gm-900m-battery-cells-it-will-never-sell.md): GM is spending $900 million on battery plants whose cells it will never sell. What a pilot line actually produces is the standing to judge a supplier.
- [Teradyne Is Suing Over Three Universal Robots Patents. All Three Expire in March.](https://www.baserealitygroup.com/field-notes/2026-09-12-teradyne-jaka-patents-expire-in-march.md): Teradyne is suing JAKA over three Universal Robots patents that expire March 2, 2027. A patent is a clock, and what you build behind it is the moat.
- [Axogen Paid $200 Million to Widen the Pool of Surgeons Who Can Repair a Nerve](https://www.baserealitygroup.com/field-notes/2026-09-11-axogen-200m-nerve-repair-without-the-microsurgeon.md): Axogen is paying $200 million for NerveTape, a sutureless nerve repair device. The asset it bought is a far larger pool of surgeons who can do the repair.
- [Nine Sites, $1.8 Million: How to Read a Hardware Company's Traction](https://www.baserealitygroup.com/field-notes/2026-09-10-nine-sites-1-8-million-reading-hardware-traction.md): Agility Robotics logged 65,000 humanoid hours across nine sites and booked $1.8 million. How to read a hardware company's traction before you believe it.
- [The Army Bought Its First Production Laser. The Factory Was Funded in March.](https://www.baserealitygroup.com/field-notes/2026-09-08-army-first-production-laser-factory-funded-in-march.md): The Army's $464.8M E-HEL award is the first production contract for a laser weapon. AeroVironment had funded the Albuquerque line six months earlier.
- [Cellares' Machine Met Every Release Spec. Bristol Myers Squibb Still Walked Away.](https://www.baserealitygroup.com/field-notes/2026-09-07-cellares-met-every-release-spec-bms-still-walked.md): Bristol Myers Squibb ended a $380M deal saying Cellares could not make commercial Breyanzi. Clinical release and commercial qualification are two different tests.
- [Stryker's Surgical Headset Is FDA Authorized. Its Own Label Keeps the Monitors On.](https://www.baserealitygroup.com/field-notes/2026-09-06-stryker-headset-label-keeps-the-monitors-on.md): Stryker's SportSuite Vision won FDA De Novo authorization on July 17. The narrow indication is what bought both the clearance and the predicate position.
- [Medtronic Paid $700 Million for a Surgical Robot It Can't Sell in the United States](https://www.baserealitygroup.com/field-notes/2026-09-05-medtronic-700m-robot-it-cant-sell-in-the-us.md): Medtronic paid about $700M for distribution rights to a surgical robot it did not build. What the Cornerstone Robotics deal says about buying coverage.
- [FDA Reclassified This Cancer Test Category. Fewer Than Five People Commented.](https://www.baserealitygroup.com/field-notes/2026-09-04-fda-reclassified-cancer-tests-five-comments.md): FDA moves oncology ISH companion diagnostics from Class III to Class II on September 16. Fewer than five people commented during the fifteen-month docket.
- [Kardium's Cleanroom Builds 500 a Year. The Business Needs 30,000.](https://www.baserealitygroup.com/field-notes/2026-09-03-kardium-cleanroom-500-a-year-needs-30000.md): Kardium won FDA approval and raised $250M for the Globe. A year later its Vancouver plant still needed $125M to go from 500 catheters a year to 30,000.
- [Two in Ten Storage Projects Now Treat the 30% Tax Credit as Optional](https://www.baserealitygroup.com/field-notes/2026-09-02-storage-projects-treat-tax-credit-as-optional.md): Two in ten US battery storage projects now plan without the 30% tax credit. Why an incentive you cannot price belongs in the upside column of the model.
- [Boston Scientific Is Pulling Catheters Its Complaint Data Never Flagged](https://www.baserealitygroup.com/field-notes/2026-09-01-boston-scientific-catheters-complaint-data-never-flagged.md): Boston Scientific is pulling its Imager II catheters with no rise in complaints behind the decision. The trigger was a gap against the approved design spec.
- [Oura Says It Isn't a Medical Device. The Ad Compared It to a Sleep Lab.](https://www.baserealitygroup.com/field-notes/2026-08-31-oura-not-a-medical-device-ad-cited-the-sleep-lab.md): A class action over Oura's 95 percent sleep accuracy claim shows what staying outside FDA jurisdiction actually buys a hardware founder, and what it does not.
- [The FDA Wants to Know How You'd Test a Device That Answers Differently Every Time](https://www.baserealitygroup.com/field-notes/2026-08-30-fda-genai-devices-answer-differently-every-time.md): The FDA opened a docket on generative AI in medical devices. The verification problem underneath it belongs to anyone shipping a product that decides.
- [Medtronic Pulled These Capsules Twice for the Same Failure. Only the Cause Changed.](https://www.baserealitygroup.com/field-notes/2026-08-29-medtronic-bravo-recalled-twice-same-failure.md): The FDA says Medtronic's Bravo CF capsule failed the same way in two recalls with different causes. Why a closed corrective action can leave the hazard open.
- [Bedrock’s Excavators Dig With Nobody in the Cab. Bedrock Doesn’t Build Excavators.](https://www.baserealitygroup.com/field-notes/2026-08-28-bedrock-retrofit-excavators-nobody-in-the-cab.md): Bedrock Robotics has excavators digging with an empty cab in Texas and Nevada. The retrofit onto iron contractors already own is what closes the sale.
- [Uber's Software Decided Who Kept Earning. The Missing Human Cost 825 Million Euros.](https://www.baserealitygroup.com/field-notes/2026-08-27-uber-825-million-for-the-missing-human.md): The Dutch privacy regulator fined Uber 825 million euros because software deactivated drivers with no human review. What that ruling asks of your product.
- [Boston Scientific's Plants Went Quiet. Its Filing Names Shipping, Not Devices.](https://www.baserealitygroup.com/field-notes/2026-08-26-boston-scientific-filing-names-shipping-not-devices.md): Boston Scientific's 8-K names order processing and shipping, not devices. Why a regulated plant stops when the network does, and what to check at yours.
- [XPeng Raised $900 Million for a Humanoid. Its First Customer Is XPeng.](https://www.baserealitygroup.com/field-notes/2026-08-25-xpeng-humanoid-first-customer-is-xpeng.md): XPeng raised over $900 million for its IRON humanoid, but the first deployments go to XPeng's own stores. Where a robot lands first tells you what it can do.
- [Every COVID-19 Test EUA Ends December 26. Authorized Was Never the Same as Cleared.](https://www.baserealitygroup.com/field-notes/2026-08-24-covid-test-eua-ends-authorized-is-not-cleared.md): HHS terminates three COVID-19 device EUA declarations on December 26, 2026. What diagnostics founders still selling under an emergency authorization face now.
- [The FDA's TEMPO Pilot Isn't Reviewing These Devices. The Companies Wrote Their Own Limits.](https://www.baserealitygroup.com/field-notes/2026-08-23-fda-tempo-pilot-companies-wrote-their-own-limits.md): The FDA's TEMPO pilot lets four digital health devices reach patients without premarket review. The companies wrote their own indications and contraindications.
- [ARPA-H Bet $175 Million on Autonomous Stroke Robots. The Hard Part Is the Room They Land In.](https://www.baserealitygroup.com/field-notes/2026-08-22-arpa-h-stroke-robots-the-room-they-land-in.md): ARPA-H awarded $175.3M for autonomous stroke thrombectomy robots. The access gap it names is a building problem, and that changes what you are selling.
- [The FDA Authorized a Blood Draw Robot. The Ratio in the Label Is the Product.](https://www.baserealitygroup.com/field-notes/2026-08-21-blood-draw-robot-ratio-in-the-label.md): The FDA authorized Vitestro's Aletta blood draw robot on August 19. One phlebotomist oversees three machines, and that ratio is the whole business case.
- [GM Walked Away From This Battery Plant Twenty Months Before It Opened](https://www.baserealitygroup.com/field-notes/2026-08-20-gm-walked-away-from-this-battery-plant.md): GM exited a nearly finished Lansing battery plant in December 2024. It opened on August 18 making grid storage cells. Why the asset survived a bad call.
- [The Navy Wants Sixteen Times the Tomahawks. The Seven Years Is What Buys Them.](https://www.baserealitygroup.com/field-notes/2026-08-19-navy-tomahawk-seven-years-buys-the-rate.md): The Navy will pay Raytheon $22.9 billion to build sixteen times more Tomahawks a year. The seven-year term, not the money, is what actually buys the rate.

## Optional

- [Field Notes index](https://www.baserealitygroup.com/field-notes.md): the running list
- [Privacy](https://www.baserealitygroup.com/privacy.md): what this site collects
- [Full text of every page](https://www.baserealitygroup.com/llms-full.txt): one file, all content