Do you ever wonder how the sausage gets made? Well, I’m specifically talking about a different kind of sausage than what you might see in most behind-the-scenes blogs or on a How It’s Made type show.
Jenn Chang, a sexual wellness product developer and creative strategist with over ten years of experience, gave a talk at SHA’s “Sexology & Media Summit” about safety and regulatory requirements as well as the stages of product development of sexual wellness products. Let’s start with some basics, and then dive into the sexual wellness product development process!
What is a Sexual Wellness “Product”?
At its most general, a “product” is something that meets a customer's needs and provides value to the business. Content and services are also considered products, but Jenn focused on consumer packaged goods or “CPG” which are physical products on a shelf. Sexual wellness products that are CPGs include lubes, lubricants, sex toys, and so on. Some of these products are more regulated than others.
Wait, Lubricant is Regulated By the FDA?
Jenn talked at length about how, in the US, a personal lubricant is actually regulated by the FDA as a Class II medical device under FDA 510(k). That means it has to go through premarket testing for things like tissue cell safety and condom compatibility before it can legally be sold as a lubricant.
I actually learned about the fine print that I would usually ignore:
Every lubricant has an "Indications for Use" line, and it varies from product to product (some may or may not be compatible with latex, polyisoprene, or polyurethane condoms, for example).
You can actually check whether a product is properly registered by searching here.
The market is full of lubes, glides, slides, creams, and some people even enjoy using coconut oil. The key distinction is that to be legally classified and sold as a "personal lubricant," a product has to be registered with the FDA.
So the next time you're standing in an aisle squinting at a bottle, know that there's a whole regulatory apparatus behind that little "indications for use" paragraph.
Are Sex Toys and Devices Regulated?
Short answer: not really. Sex toys and devices are largely unregulated in the US and sold under the "novelty" label, which means there's no formal oversight comparable to lubricants or supplements.
That said, there is a relevant voluntary international standard: ISO 3533, introduced in 2021. The standard apparently originated with a doctor in Sweden who got tired of patients showing up needing help safely removing sex toys, and pushed for standardization. ISO 3533 covers things like:
Risk assessment and safety, especially for anything that comes into contact with genitals or the anus
Design requirements, including that insertable items must be easy to remove without specialized tools, and free of hazards
Material safety, including restrictions on hazardous substances
Electrical safety, for obvious reasons (nobody wants a toy that shocks them mid-play, at least not in a way that's genuinely harmful)
Temperature control, for warming products, which must not exceed 41°C (or 106°F for my readers from the USA)
User information, such as instructions, which some companies mold directly into the packaging or product to increase the odds people actually read them
It's voluntary, but it's the closest thing the industry has to shared safety expectations.
What Are the Stages of Sexual Product Development?
In her talk at the event, Jenn walked through her sexual wellness product 7-step development process. She uses a stoplight system, not unlike how many of us think about consent: green light, keep going; yellow light, proceed with caution; red light, stop.
1. Market Research
Before anything gets built, Jenn starts by answering two questions:
Consumer needs: Who's the buyer, and what do they actually want from a sexual wellness product?
Competitive landscape: What already exists? What are the features, and what do they cost?
2. Idea Screening
Jenn uses the classic Iron Triangle framework (i.e. products can be two of the following: quick, good, or cheap) to figure out what resources are actually available, and where a product idea falls on what she calls the Creation Spectrum:
White/Private Label: The product already exists, so you would be building your brand around it.
Hybrid: Something like the sexual wellness product you’re looking to make already exists, so you’re really customizing a few key pieces.
True Creation: In this case, you would be essentially starting from scratch, building the formula, mold, or concept from scratch.
3. Product Design & Prototyping
Once an idea is locked in, Jenn builds out a brief called the Product Requirements Documentation or “PRD.” It answers seven core questions:
Intended use & performance: What is this for, and how is it used?
Formula/material spec: Should it be glass, silicone, or stainless steel, and why?
Regulatory & safety testing: What does it need to pass, and with which factories?
Target COGS: What's the cost of goods, and what can the market bear at retail?
Packaging requirements: It has to survive transit, sit nicely on a shelf, and look good doing it!
Claims to substantiate: What are marketing and the team allowed to actually say about the product?
Timeline & milestones: Product development can take anywhere from a couple of months to five or even ten years, depending on complexity.
Something I had not considered was an interesting consideration in this step Jenn mentioned. Getting feedback is typically much easier for lubricants than for devices. You can pass along lube samples the way you'd run an eye exam ("do you like 1 or 2 better?"). Toys and devices are harder to mass-sample, since companies generally can't just hand out physical prototypes to a wide pool of testers and you shouldn’t be double-dipping there, per say.
4. Product Roadmap
The PRD feeds directly into the roadmap, consisting of concrete milestones, resource requirements, and decision points, typically owned by a cross-functional team spanning R&D, Marketing, Sales, Operations, and Finance. This is also where the big-picture questions come in, like where the product will actually be sold and how the finances and demand planning shake out.
5. Market Strategy
Jenn emphasized a few key focus points of developing a market strategy:
Packaging appeal: Would someone actually pick this up off a shelf?
Pricing: Does "affordable" actually hold up at the register?
Claims: What do you want to call out or educate consumers on?
Packaging and labeling sometimes have to shift based on retailer restrictions or general concerns about what's appropriate to display. Jenn noted that products can get killed simply because the packaging doesn't invite someone to pick it up and take it to checkout in the first place.
She also gave a nod to adult stores specifically, which tend to do a much better job of educating customers on how to actually use certain toys, compared to more general multi-purpose retailers.
6. Sourcing & Manufacturing
This is where things go from "sample on a desk" to "thousands of units on a shelf." Once the retail market has given the green light, Jenn works with manufacturers to confirm materials, equipment, and costs so the product can be delivered consistently at volume, all while locking in quality control and regulatory requirements.
There seemed to be an acronym or two associated with every step. In this case it’s “PPS”, or pre-production sample which is the first sample that comes back closest to the final product. This is the "okay, sign here" moment before the manufacturer commits to producing thousands of units.
7. Product Launch
At this point, it’s time to celebrate. The product exists, it's been approved, and now sales and marketing take the wheel: retail placement, and the advertising, outreach, and promotion that actually gets customers to know the product exists.
That last piece is, in Jenn's words, notoriously difficult for this category. Sexual wellness brands routinely run into platform restrictions and content censorship that other CPG categories simply don't deal with.
And that is how the proverbial sausage gets made!
Want to become an in-demand sexual health professional? Learn more about becoming certified with SHA!
Written by Jesse John, B.S.
Jesse is a clinical psychology doctoral student at Rowan University in New Jersey. Their research focuses on sexual decision-making, sexual violence, and relationship experiences. The author identifies as a Queer, neurodivergent, non-binary, white person, which informs the way they write and see the world!
