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Medical Device Start Ups and Connectivity

Much like solving the original problem with an innovative product design, finding an answer to the connectivity problem starts with asking the right questions.

Entrepreneurs are all about commercializing their novel technology, getting to market, driving adoption and realizing an exit strategy. Yet with the incredible focus on transforming their novel technology into something customers can buy, few startups take connectivity requirements into account until too late in the process. The consequences frequently result in revised go-to-market strategies, like going to market without important features or shifting to niche markets with lower connectivity requirements.

Customers Want More than the Box

There are many barriers to entry in health care: regulatory hurdles, entrenched competitors and gatekeepers like group purchasing organizations (GPOs). Increasingly, connectivity is becoming a barrier to entry - or perhaps a new price of admission. There are few medical device product categories that don’t have some connectivity requirements. (More on the actual requirements below.) But besides buying the embedded device, providers are increasingly interested in buying whole product solutions.

Coined by Geoffrey Moore, a whole product solution is just that, all of the components and services required to fully realize the potential of the overall solution. Thus if one of your connectivity requirements is integration with an EMR for electronic charting, just putting a serial port on your device is not a whole product solution. Of course neither do you have to do the whole solution yourself. Frequently the best strategies entail providing part of the solution directly (developed yourself, outsourced, licensed, etc.) and creating the rest through business development and alliances with other vendors.

Connectivity As Competitive Advantage

Sometimes connectivity can be leveraged to gain competitive advantage. Point of care testing (POCT) startup EPOCAL is a great example. This company has apparently done an exemplary job in recognizing market requirements and formulating a design that maximizes connectivity features and capabilities, while minimizing development costs and time to market. If this new system is successful, established competitors will have to scramble to catch up.

CardioNet is another startup that leveraged connectivity from the get go.  The acquisition of ECG signals is pretty routine. The algorithms for analyzing ECGs are also well understood, but continues to yield occasional innovations. Besides superior ECG analysis algorithms, CardioNet implemented a near-continuous connection with a remote service center that wirelessly acquires and reviews patient ECG waveforms - during the diagnostic test. This continuous recording and analysis contrasts with conventional holter monitors that record a batch of heartbeats (typically 24 or 48 hours) that are read at the end of the study. This unique connectivity enabled workflow provides CardioNet with unique clinical capabilities that have resulted in much higher diagnostic confidence than conventional holters - and a sustained competitive advantage. Continue →

June 24th, 2008 | Published in Business Planning, connectivity  |  1 Comment

Previously


AAMI 2008, San Jose, Day Two

“We can’t solve problems by using the same kind of thinking we used when we created them.”


AAMI 2008, San Jose, Day One

There is special focus on workflow analysis.


What’s Wrong with the Proposed FDA MDDS Rule

It is foreseeable… that an MDDS could initiate a command to a medical device that results in unintended operation of the device.


IEC 80001 - An Introduction

The intent of this standard is the application of risk management to enterprise networks incorporating medical devices.


Selling Connectivity - Sales Strategy

The qualification step, an event that clearly demonstrates the prospect’s intent to buy.


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