Medical & Scientific

Outerspace understands the medical product development process

The unique language, standards and guidelines of regulated medical device development. We work closely with regulatory and quality specialists to develop appropriate strategies. With years of experience in Class 1 and Class 2 medical product development, we translate and help verify our client’s core technologies into viable manufacturable products.

We understand patients, conditions and the environments that diagnostic devices and instruments are used. We work with clinical specialists to improve tools and processes to improve clinical outcomes.

We have years of experience in a wide range of medtech diagnostic sectors ranging from neurology and opthalmics; to cardiac instruments, in vitro devices, hearing device systems, drug delivery products and wound treatment devices.

Precision That Can't Fail Quietly

We built Arc by Varivac, a variable vacuum negative pressure wound drainage pump, and it won a 2025 Good Design Award in the Engineering Design category. The jury praised its holistic approach to patient comfort and flexibility. In a medical device, comfort and function aren't separate design problems, they're the same one.

For Medical and Scientific Design at OuterSpace, we work in Class 1 and Class 2 medical product development, and we translate a client's core technology into something that can actually be manufactured and certified. Regulatory and quality specialists sit alongside our engineers from early in the process, not brought in at the end to check our work.

It has to work even when nobody's watching for it to fail.

The Standard Is Different in a Clinical Setting.

We design for the environments diagnostic devices actually get used in, clinics, homes, hospital wards, not lab conditions. That means designing for patients who are anxious, in pain, or unable to hold still, not just for the technology itself.

"The Medmont Meridia Vantage has become an essential part of my clinical workflow," says Hanish Patel OD, Founder and Partner at Eye Associates of New York. "It has reduced the number of trial lenses I need for sclerals, allows me to clearly monitor ortho-k treatment patterns, and provides objective imaging for dry eye that makes patient education much easier." We built the compact optical cone and single-handed joystick that made that workflow possible.

In-house capabilities:

Neurology, ophthalmics, cardiac instruments, in vitro devices, hearing device systems, drug delivery products, wound treatment devices, regulatory and quality strategy

Standards we work to: Class 1 and Class 2 device classification, ISO 13485, IEC 60601, ISO 14971, TGA / FDA / CE approval pathways