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Medtech Startup Showdown 2017: Round 1—Linear Health Sciences vs Shift Labs


Posted in Medical Device Business by mthibault on March 20, 2017

 

Linear Health Sciences

vs.

Shift Labs

 

 

 

Describe your device and how it will benefit healthcare.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The Orchid Safety Release Valve is designed to mitigate IV dislodgment by integrating its patent pending valve design in to existing IV sets between the extension set and administration set, using standard luer connections. When a predetermined tension acts on the IV line the valve will break away, sealing the flow path—creating a sterile barrier on the system. Instead of resticking a patient, introducing another needle, or moving toward a more invasive procedure, the practitioner can simply remove the activated halves of the Orchid SRV, dispose, and attach a new Orchid SRV in its place to restart treatment.

The benefits for healthcare fall in to three categories.

For hospitals:

  • Reduced potential for infiltrations, phlebitis and healthcare-acquired infections.
  • Cost savings due to fewer time-consuming, costly ($30 average hard cost) IV restarts after accidental dislodgements; reduction in potential for phlebitis, infiltration, and other healthcare acquired conditions, including infection; greater patient satisfaction and fewer complaints about repeat needlesticks. 

For nurses:

  • Greater efficiency through avoiding dislodgements and unscheduled IV restarts.
  • Less exposure to sharps injuries and potentially infected blood.
  • Ease of use: Integrating standard connectors with Orchid SRV doesn't require any special training.

For patients:

  • Fewer IV restarts including painful needlesticks
  • Reduced potential for more invasive treatment such as central lines placed due to loss of peripheral IV integrity

While this alone is set to fundamentally change the standard of care for patient/provider safety and satisfaction, the implications of the tech are much farther reaching—in to a multitude of other medical tubing applications such as Foley catheters, chest tubes, and insulin pump delivery catheters.

 

The DripAssist Infusion Rate Monitor was created to make gravity IV infusions more reliable, accurate, and efficient. It’s a simple handheld device that was developed to help all healthcare workers, in any setting, to precisely and affordably manage IV infusions.

Infusion pumps are commonplace in U.S. hospitals, but there are still many clinical settings worldwide where IV medications and fluids are administered via gravity infusion with a roller clamp or flow controller. DripAssist quickly attaches to any gravity IV drip set to continuously watch flow rate and volume during fluid and medication administration. It takes less than five minutes to learn, uses one AA battery, and works instantly with any tubing set.

DripAssist is an FDA-cleared and CE-marked solution developed for clinical settings where infusion pumps may not be a viable or efficient option, or where a portable and lightweight IV monitor is needed.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

How does your product differ from the competition?

 

 

 

 

 

 

 

 

 

 

 

 

Existing IV administration and extension sets have remained unchanged in 20 years, creating one of the most commoditized product offerings in medtech. Another competitor is mirroring Linear Health's development pathway toward FDA approval, but its own tension based breakaway valve has several limitations when put side by side:

  • Spring based system—Metal in line was removed from IV disposables 20 years ago, and it lacks MRI/potential drug compatibility versus Linear Health's standard material use.
  • Power Injection support—The competition will not be able to integrate its product with power injection applications, like the Orchid, limiting its use.
  • Cost competitiveness—Based on manufacturing review given existing designs, the competitor will not be capable of scaling manufacturing/commercialization near to the potential of the Orchid's more affordable price range.
 

Infusion pumps are a mature technology, however, the majority of infusions done globally are still provided via gravity IV. There is currently other no tool that accurately monitors gravity infusion. The most significant market threats are flow controllers and complacency with the status quo of unmonitored infusions.

In the past, there have been competitor products that performed drip counting, prior to the availability of low-cost, sophisticated software and electronic capabilities. DripAssist uses infrared to detect drops, and the electronics convert that information into a flow rate and volume display with 99% accuracy.

 

 

 

 

 

 

Do you have customers yet?

Product is not yet commercially available, however pilot sites are being developed - engaging in letters of intent to integrate product in to use.

   

How much money have you raised?

 

Linear Health Sciences has raised $1.25M in series Seed round, slated to formally open up a Series A round of $5M in coming months. Currently being vetted by several Venture Capital Firms regarding Series A.

 

Seed rounds totaling $1.6M raised in 2014 and 2015, $100,000 raised for Note conversion in 2016. Nondilutive funding from USAID of $300,000 in 2015.

Who are your investors?

 

 

 

 

Series seed investors include a nonprofit state fund in Oklahoma City, an angel investor group, and an individual investor group. Eighty-five percent of the angel/individual groups are practicing physicians and nurses.

 

 

 

 

What is the next milestone for your device?

 

 

Primary inflection point is 510(k) submittal/FDA approval slated for late August. This will be the primary inflection point of the series seed round of funding.

Following this and manufacturing scaling, given Series A funds, pilot site integration will follow, alongside formalized commercialization.

 

Expanding distribution network

 

 

 

 

 

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