In Brief.

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Onesys Medical was founded in 1991 to develop a pioneering first-generation Surgical Navigation System, the Onesys Neuronavigator System.

It all began as a small project managed by the company with the help of a neurosurgical clinic at Oulu University Hospital.

The company sustained a setback in the form of a force majeure in 2009 which put much of the company's plans on hold. We are finally ready to put that chapter behind us.

We are currently embarked on two new products:

A 3rd generation surgical navigation system, and;

A mobile-native variant of the Onesys Navigator software, which will be the smartphone form-factor GUI with which to integrate smartphones and the EHR.

For a more comprehensive telling of our history, read below.

Chapter 1.

Hi reader.

Glad you're here.

"What is Onesys?"

Many ask us this question. We've never really bothered with storytelling, we just sort of do things and worry about the story afterwards.

But this is the age of stories, narratives and vision.

So it'd be remiss for us not to tell ours.

What follows is - though this might be difficult to accept - a small sampling of our work in medical technology.

Our story began as is the case with many great companies, with a "simple problem" that demanded a complex solution.

 

 

 

The first problem: "In order to operate, I have to know where the tumor is. I can't see it."

Our first patent. US5413573A, 1995. The technology described herein is a so-called "passive arm robot" or as we call it internally "a first-generation surgical navigator" which has since been replaced by second-generation navigators which are based on optical, typically twin camera IR systems.

Figures 1 and 2 showcase the arm itself, but it's in figures 3 and 4 that you will find the kind of thinking that set us apart then and sets us apart today.

We weren't the first to get a machine into the OR. But we were one of the first to do it in a way that made practical sense.

 The second problem: "How do you get 200lbs of steel and corners into an OR clean room, and keep it disinfected between operations?"

Answer: Plastic bags. And magnets.

We proved that plastic and magnets allow for the transfer of electrical current and, crucially, data in the form of sensor readings. This plastic bag idea is in use in most technologies ever brought to the OR, where electical devices are concerned. As of May 2020, this patent has over 400 citations.

None of this would have been possible without the work of many great minds at the time.

 

 

 

 

 

 

Let's keep things simple. This navigator is simply a mouse.

An XYZ pointer. You point the instrument at a thing, the computer figures out what your orientation is in relation to that thing by translating your movements in real space into movements in virtual space in relation to an imaged thing.

2D images -> 3D construct (but let's not get ahead of ourselves, yet)

Without this, the navigator is sort of like your mouse without a computer screen. Pointless.

So you need a way for a physical pointer to interact with a virtual image. A 3D image. You also need a way to render 2D images as 3D images (because no one's invented a 3D scanner, yet), store those images in some form of memory (typically RAM) and.. Well. I did promise to keep things simple.

That sounds like a patentable idea though.

US2007032720A1, 2007.

 
 
 
End Chapter 1.

Chapter 2.

You're still here?

Good.

You might be wondering: "What exactly is Onesys doing now that is relevant?"

What we've always done.

Invent new things.

Enter, the third problem:

"Now that digital systems are coming and analog storage is on the way out, how can we keep information accessible, interoperable and usable?"

You see, in building the surgical navigator, we were given a choice:

1. Build a system to store images on a server somewhere (because as you recall from Chapter 1, the navigator can't work without images: A pointer doesn't work without something to point at or against), i.e.

PACS -> Our server, or

DICOM -> Our server, or

 

2. Something else.

Instead by using existing servers, health records and archives and accessing images directly, we built an integrator - a server-client software suite which truly incorporates data from any source.

We call it the Onesys Navigator. Because it allows a physician to navigate even complex medical histories and share the gained insight with others.

It began as a means to an end: Making the surgical navigator practically usable in any hospital with minimal installation necessary.

 

Little did we know just how much EHRs would change medical care. How difficult it would become for data of any kind to be moved even from one hospital unit to the next (from radiologists to oncologists, for instance), let alone one HIS to another.

The ON continues to be the only scalable solution to this problem, with the above in mind.

That sounds like a patentable idea.

US20070266046A1, 2007.

What's it look like?

Like this. Click to enlarge.

In the image you can see:

On the bottom-left, "Workspace History" refers to previous ON workspace instances, as they relate to this Case. We'd love to tell you more about Cases.

Above it on the top-right, you see "Annotations", this is free-form text entry, diagnostic notes and such things which allows for the physician to collect the relevant, pertinent information into one glance.

We'd love to tell you more about pertinent information.

Above this, 2D and 3D Images. Our software comes with an inbuilt 3D rendering engine which allows a clinician or a surgeon to render 2D PACS/DICOM as interactive 3D slides.

We'd love to tell you more about why this is incredibly useful.

To the right, we see "Snapshots." These are source data from other archives such as images, labs and so forth. Anything from volumetric tumor growth curves over time to simple 2D PACS/DICOM image studies or 3D renderings thereof.

Snapshots come with inbuilt functionalities such as thumbnails, time of snapshot and the name given to the snapshot describing perhaps the reason or the finding.

Once information - whether text, image or lab in nature - has been collected into such a "workspace" (imaged), these workspaces can be saved, shared and exported. Sharing and export differ in the sense, that a Shared workspace allows others to make Instances into the Case, whereas Export merely contains the content and no ability to edit.

 

The doctor uses the workspace as the first and last point in the diagnostic process and this eliminates as much as 90% of frivolous busywork of finding "that one image" from a set of 30, or reading through page after page of "potentially useful" information again and again, looking for the relevant bits.

The worst case scenario is that someone still has to go through the above ordeal for old data, but only one person has to do it and only once. Even this is huge progress.

The ON allows physicians down the road to familiarize themselves with patient cases that might have decades worth of data associated with them, in as little as 5 minutes.

The time saved is immense.

Another added benefit is the ability to keep everyone in the loop - doctors could be given for instance a copy of the diagnostic process for a patient, which allows for training and education to take place. When sending a patient to a hospital, the GP gains valuable insight.

End Chapter 2.

Onesys_Navigator.png

FORCE MAJEURE

Not a happy chapter.

In 2009 the company was hit by a lot.

A catastrophic accident disabling the acting CEO in the middle of Global Financial Crisis put us in a dark place.

This led to soul-searching followed by bootstrapping:

Was there, is there a point for us to keep going?

Yes.

Chapter 3.

What's next?

  • 1. We're working on the OMN or "Onesys Mobile Navigator." Patents pending. [1]

  • 2. We're working on a 3rd generation navigator. Patents pending. [2]

  • 3. We're launching a smart card solution, available currently to select partners. Negotiations ongoing. Patents pending. [3]

  • 4. We will be publishing research, whitepapers and will work with stakeholders and partners to advance clinical technology.
     

  • 5. We will also do our part in combating the COVID-19 epidemic with modern technological solutions, including artificial intelligence.[4]

[1] The Onesys Navigator GUI has proven itself to be a novel, concise and practical means of documenting and visualizing the diagnostic process, adding functionality otherwise absent in a contemporary EHR.
We believe that our GUI, along with its underlying technology and approach, is the demonstrably superior method of data access, use and sharing in the smartphone form-factor for the 21st century.

We are looking for an OEM to make this a possibility. Negotiations ongoing.

What's stopping OEMs from penetrating the healthcare vertical today?

As the reader will likely know, HIPAA (USA) and MDR/IVDR (EU27) make any smartphone application in medical use a complicated issue:

In the most basic of terms, the moment medical data (PHI, medically-relevant PII, EHR data) enters a smartphone, the phone becomes a "Medical Device."

The magic word thereafter is "Consent." Managing Consent for all archives and records systems in a typical HIS is fraught with challenges. Having a single point of interaction (the "ON workspace") allows for the patient to unambiguously know what their data is used for and when and is exceptionally easy to monitor ("ON workspace access management").

This, is one key reason why data from consumer wearables, blood pressure monitors and other measurement devices have seen virtually zero adoption in healthcare.

Specifically, while "information" can move (the patient can simply show a piece of paper or a data readout to a physician), data itself is very challenging, often impossible in practice, to incorporate into an EHR as anything more than an observation.

[2] As mentioned elsewhere, ours was a "first generation" navigator, since made obsolete by second generation optical navigators. We believe that our experience in navigation in general gives us an unrivalled ability to envision - and build - the next natural chapter of "medical virtual/mixed reality."

[3]  Medical data is a problem, still:

In the USA, 75% of medical information between HIS moves via FAX. In Finland, by printing.

Images move via CD-ROM in both markets.

[4] COVID-19 is a disease caused by the novel coronavirus nCoV-SARS-2. As a novel coronavirus it's requiring us all to figure out new, smarter ways to do diagnosis.

One of these involves imaging, and the other specific kinds of blood tests looking for certain things. Both approaches necessitate algorithmic solutions and at-scale deployment in complex HIS at the operative level.

 

Apart from these potential opportunities, the ON possesses utility in interoperability, specifically as it relates to sharing of specific information or collections of information with authorities, such as national institutions tasked with tracking the epidemic. Many such solutions today use pen and paper combined with the latest in landline telephone technology and FAX.

This is especially true when discussing COVID-19 diagnoses made without the use of PCR-testing, as may be the case in national pandemic strategies as they were formulated in response to H1N1.

The technologies unless otherwise specified are properties and/or patented properties of Onesys Oy, Finland. This list of activities or plans (together "What's next") are forward-looking statements which constitute no obligation on behalf of Onesys to you or any person or entity. All material disclosed herein is public domain or privileged. Patents current and non-current constitute Onesys intellectual property rights (IPR) with absolutely no conflict of interest with any other party. No claims are made herein unless expressly defined in the patents cited. Claims may or may not be current as of the time of reading. Onesys is under no obligation to inform you as to the current patent status should they lapse or expire in the future.

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