Every number has a source
Market figures come as a range with the publisher named, because estimates vary a lot depending on who you ask.
A YouTube channel about wound care devices
Wound care, from the wound up.
Devices, markets and regulation explained in plain English, by someone who has spent 30 years building them.
Launch film
The channel in about a minute.
The Wound Brief · launch filmwith Christian Stephenson · Karandash Consulting
Why I started The Wound Brief
I've spent 30 years getting medical devices from an idea to a patient. Most of it I learned the slow way.
Wound care is a small corner of medtech with a lot packed into it. A dressing looks simple. Behind it sits materials science, sterile manufacturing, stability, biocompatibility testing, design control, risk management, clinical evidence, regulatory systems and a buyer who has to be convinced it's worth the money.
The knowledge exists. It's spread across regulations, standards, guidance documents and the heads of people who have done it before. Very little of it is joined up, and that makes the field harder to get into than it needs to be.
The Wound Brief is my attempt to join it up. I want people new to wound care to understand why it works the way it does. I want anyone weighing up a career in it to see how interesting it is. And I want experienced teams to get a fast, independent read on what is changing.
This field has been my working life, and I still think it's one of the most rewarding places to build products. I hope that comes through.
Christian Stephenson
Fig. 2What sits under a dressing
What you see: a dressing on a shelf
what it takes to get it there
- Materials, and how they handle wound fluid
- Sterile manufacturing and cleanrooms
- Biocompatibility testing
- Design control and risk management
- Clinical evidence behind every claim
- EU, UK and US regulation
- A buyer who has to see the value
The series · beginner to advanced
Four layers. Start where it touches the wound.
Each series is one layer of the stack. Foundations sits closest to the wound, where everyone starts. Each layer above goes deeper, and The Briefing faces the outside world, keeping you current.
Where to start
Tell me where you are. I'll point you at the right layer.
Pick the line that sounds most like you and you'll get a route through the series, in the order I'd watch them.
How it sounds
“A dressing for a wound that goes through the dermis and has to heal from the bottom up healing by secondary intent is Class IIb.”
Plain English first, technical term second. Half the audience needs the plain version, and the other half doesn't mind hearing it. That's the rule for every episode.
Standards
The rules the channel keeps.
Proposed is never blurred with final
A proposed rule and a rule in force are different things. Every episode says which one it's talking about.
Primary sources first
The regulation text itself, then MHRA, FDA and MDCG guidance, then company filings. Trade press comes second.
EUR-Lex · legislation.gov.uk · eCFR · Federal Register
No clinical claims, no clients named
I never comment on a product's clinical performance beyond its own labelling, and I never name a client.
Made in the open
AI helps with the design and presentation of every episode. The research and opinions are mine.
Education, not advice
Commentary and education, not regulatory advice. Check the current text of any regulation before relying on it.
years in medical devices, from start-ups to blue-chip companies
Who's behind it
Christian Stephenson
I'm Christian Stephenson from Karandash Consulting. I've spent 30 years in medical devices, from start-ups to blue-chip companies.
I've run R&D at one of the biggest names in wound therapy, led R&D, quality and regulatory at a UK wound care manufacturer, built and sold a company, and sit as a non-executive director. Today I help companies get wound care products to market.
- FormerlyVP R&D, Acelity / KCI
- FormerlyR&D, quality, regulatory and board roles, Crawford Healthcare and Smith & Nephew
- Hands-onBuilt scores of products from cradle to grave
- NowFounder, Karandash Consulting
Working on a wound care product?
If your team is bringing a wound care product to market, I can help.
I support that work through Karandash Consulting: development, manufacturing, regulatory strategy, commercial strategy and the decisions in between.