I recently conducted an interview with Larry O’Cull, President of Priio on the topic of medical device prototyping.

Creo Quality: Tell us a little about Priio. Give us the 30-second pitch.

Larry O’Cull: Priio does ‘whole solution’ product development, whether it’s creating new products or fixing current problems. We generate products from basic concept to anywhere along the ideation-to-creation process using industrial design, software development, and mechanical and electrical engineering (often small medical or electronic devices with interactive intelligence).

Our ‘special sauce’ is a keen understanding of human factors engineering – because we believe product function should be obvious to the user as well as pleasing in design.

CQ: When is the right time to build a prototype?

LO: It depends on your goals, and where you are on the development timeline. If you need a “proof-of-concept” model, a little clay and duct tape might be enough to tell you whether or not an idea is feasible. If you’re seeking late stage funding, a fully realized “looks-like, feels-like” prototype can be a great tool for gathering user data and market feedback.

CQ: What types of prototypes are there?

LO: There are several type of prototypes, including:

• Proof-of-concept Model – a crudely formulated model (also known as the “Quick and Dirty”)
• Form Model  - a prototype that “Looks Like” the end product; not interactive or functional
• Functional Model – a prototype that “Works Like” the end product; used to prove usefulness
• Interactive Functional Model – a computer-based interactive device, such as a diagnostic meter, a web-site, an app, etc.
• Clinical-Use or Field-Use Model – a pre-production product that is ready to go into the field for human-interaction study and product use validation. (This models may be handy in regulatory testing for agencies such as UL, CE, FCC, TUV, FDA, FAA, etc.)

CQ: Describe a few of the preferred prototyping methods used by Priio?

LO: Some of Priio’s everyday methods for realizing mechanical components include:

• 3D printed models from either a fused-deposition-modeling machine (FLM) or stereolithography assembly machine (SLA)
• Urethane-foam models hand-shaped or milled on a CNC machine
• Cast-urethane molded models

We often create electronic devices with software on board, so we’ve been known to hack up/bodge together manufacturer-supplied demonstration boards and sample softwares in order to get something working fast. We may also build and test a user interface for a hand-held instrument on a PC before before we even begin to create the instrument itself.

We find CAD simulation tools are also an effective way to prototype – we can simulate some circuits or “twist” a mechanical part in-silico (on the computer) before we ever create a “real” printed circuit board or mechanical component.

CQ: Describe Priio’s typical medical device client? What stage are they usually at?

LO: Our medical device clients range from startups to large experienced companies, with products ranging from invasive diagnostic instruments to pharma-storage environments used on aircraft.

In the case of startups, it’s generally early stage. Having proven some feasibility in the lab, a scientist, bio-engineer, etc. will now seek to commercialise the idea.

In the case of some of more experienced clients, they may already have market presence but are seeking to bring on something new or update a current product.

CQ: Priio develops products for multiple industries. What special circumstances and considerations that Priio must consider for medical device prototypes?

LO: The design process at Priio is generally the same regardless of market, although medical devices typically require extra documentation and due diligence. Occasionally other industries require levels of due diligence compatible with the FDA, such as those which manufacture devices that must intrinsically-safe, explosion-proof, or concerned with safety..

The FDA seems pretty consistent about safety and patient and end-user needs. They have established a “minimum code” (IEC-60601) to use when constructing a device or product, mechanically and electrically. This guidance code is usually required even at the prototype stage – because if the device is even potentially unsafe you cannot use it for collecting field-trial data.

CQ: What do you view is the biggest obstacle for medical device entrepreneurs / inventors?

LO: The biggest obstacle for nearly every entrepreneur is funding. With the current economic climate (particularly in Indiana) there seems to be much more late-stage than early stage funding available.

Medical device entrepreneurs have an added disadvantage of regulatory agency requirements (FDA 510K) that increase costs – easily doubling or tripling cost of development over other market segments.

CQ: When clients approach you, have they proven the science behind their ideas or do they expect Priio to do this work?

LO: Some of our clients would like us to help them prove their science, but for the most part they come with basics already established.

We do find, however, that re-proving the science is common. Once a concept is realized to commercial form, a validation process (usually a field study) is necessary. This is a good path because it uncovers any potential anomalies.

CQ: Do you have any medical device product development case studies you are able to share, including images?

LO: Therametric Technologies, Inc. (TTI) came to Priio asking for a wireless, battery powered, hand-held device which dentists could use to get diagnostic photographs of individual teeth.
Expediency was important for testing this product because the expense of dental research is often prohibitive to marketing innovations.  With this in mind, Priio devised an alternative: an ergonomic hand-held device which accomplished the required task but without wireless connectivity and battery operation, instead using USB as the power source and data connection to the analysis computer. The solution was cost effective and quick to develop and produce “looks like/works like” models that could be used for testing.