What Does It Take to Become Patient-Ready?

For our 9th San Diego Hardware Meetup, we focused on Medtech — Pathway to Patient-Ready.

I liked this topic because “patient-ready” sounds like a destination, but getting there involves a lot more than proving that the technology works.

You have to understand the user. Design something they can actually live with. Work through engineering constraints. Think about manufacturing. Build trust.

And, depending on the product, navigate regulatory requirements and a market that may already have very established ways of doing things.

We had three speakers looking at that journey from very different perspectives: Kaheawai Kaonohi, founder and CEO of The Disabled Soloist. Young Lee, Lead Industrial Designer at Dexcom. And Brian Coullahan, Director of Regional Market Development at Element Biosciences.

Start with the person using it

Kaheawai’s presentation was probably the clearest reminder that a medical or mobility product is still a product somebody has to use every day.

The Disabled Soloist is looking at mobility devices differently.

The problems he highlighted weren’t only functional. They included aesthetics, size, customization and comfort.

Existing devices can feel clinical or impersonal. They can be difficult to travel with. Customization can be limited. And extended use can create pain and strain.

Their concept is a modular system across canes, crutches, walkers and wheelchairs.

What I found interesting was the perspective behind it. When you’re developing something for healthcare, it can be easy to define success around whether the product technically performs its intended function.

But the person using it doesn’t stop being a person because they’re using a medical or mobility device.

They still care about how something looks. How it feels. Whether they can travel with it. Whether it fits into their life. That’s part of the product too.

Industrial design comes in much earlier than appearance

Young’s presentation gave another perspective on that same idea.

Industrial Design is not about making things look good.

I liked that because industrial design is sometimes brought into a conversation too late, almost as if engineering finishes the product and design then makes it look better.

His presentation showed something very different.

Industrial design can sit across the entire development process — market research, human factors, mechanical R&D, operations, regulatory, brand and the customer experience.

At the center of that is the user.

User Needs = Business Needs.

Young used his experience working on the Dexcom G7 to show how those decisions become very practical.

Cost, size, usability, manufacturing and appearance don’t live in completely separate boxes. They affect each other.

One example from the presentation compared a previous receiver at around $400 with a next-generation target of $40.

That’s a pretty significant constraint.

And it shows why good design isn’t just about asking what you could build. It’s also about understanding what the product needs to become.

A good product still has to earn trust

Brian’s presentation with Element Biosciences moved us into a very different part of medtech and life sciences: DNA sequencing.

Element’s goal has been to lower some of the barriers to high-quality sequencing so that more laboratories can generate their own data.

What I found particularly interesting was the discussion around entering an established market.

Having different technology isn’t enough. You have to give customers an economic reason to switch. You have to fit into workflows that already exist. You have to build credibility against established players. And you need enough data and real-world evidence for people to trust the platform.

Element framed those barriers around economics, switching costs, trust and credibility, and demonstrating genuinely differentiated applications.

I think that applies well beyond sequencing.

In medtech especially, technically better doesn’t automatically mean adopted.

If a product requires customers to completely change the way they work, creates additional risk or doesn’t yet have enough evidence behind it, adoption can still be difficult.

The path toward the patient is also a path toward trust.

Patient-ready isn’t one engineering milestone

That’s probably what I took away most from the evening.

There isn’t one point where engineering finishes and suddenly the product becomes patient-ready. It’s much more connected than that.

The Disabled Soloist showed how deeply understanding the person using the product can change what you decide to build.

Young showed how industrial design, engineering, human factors, business and regulatory considerations have to interact throughout development.

And Element showed that even after the technology works, getting it adopted requires economics, integration, evidence and credibility.

Different products. Different stages. But the same general direction.

One last thought

In hardware, we talk a lot about getting from prototype to production.

Medtech adds another question: Getting to production for whom?

A product can work technically and still not fit the user. It can be beautifully designed and still be too expensive. It can perform better and still be too difficult for a customer to adopt. And it can be manufacturable without being ready for the environment where it will eventually be used.

Patient-ready is probably less of a final checkpoint and more the result of getting a lot of those decisions to work together.

That’s what made this meetup interesting for me.

A big thank you to Kaheawai, Young and Brian for sharing their experience, to Expertise Engineering for hosting and sponsoring the evening, and to informal for continuing to support the San Diego Hardware Meetup community