The Model and The System of MedTech Start-up Success

Guest blogger this week:
Stuart Kozlick, BCF Chief of Healthcare Technology Strategies and Business Development

Steve asks:

“Given your extensive and broad business experience with MedTech start-ups, as well as with Small-Medium-Large enterprises, what critical advice would you give to entrepreneurs, scientists and engineers interested in creating a successful start-up?”


Stuart’s reply:

Reflecting on my experience over the last 16+ years in medical device development, I’ll turn to my specific experiences with all sizes of companies.

No matter the size or the maturity of the organization at the time, these two key principles come to mind: (i) the ‘model’, and (ii) the ‘system’.

The ‘Model’

Regardless of the size or maturity of your organization, the technology track being pursued, the “disease” state or otherwise, one thing is for sure: your organization’s business cannot remain static in time as your company evolves.

For several decades, the standard operating model for medical device manufacturers of all sizes has been to bring good technology to patients and the market will reward you. This model and mindset is becoming more and more obsolete.  

Device companies need to revamp their traditional mindset to show how their products are not only efficacious to the patient population, but also have a positive impact on the respective health economics in which they will be playing.  

The MedTech sector is presently navigating the shifts in healthcare, including:

·      the transition from volume-based to value-based healthcare models

·      the application of real-world data in researching and commercializing therapeutics

·      the addition of patient services in improving outcomes and the increased presence of technology firms involved in patient care.

At the same time, the sector needs to continually transform their technology offering and core operations, ensure competitiveness in their operations, and leverage new developments in, for example, IoT in manufacturing and supply chains to remain ahead of the curve.

For you engineers and scientists out there, I would look at a business model like this: business modeling is the managerial equivalent of the scientific method – you start with a hypothesis, which you then test in action and revise when necessary. Keep this in the back of your mind as your business evolves and grows, and don’t be afraid to adapt to change.

The ‘System’

I can’t tell you how often I have conversations with entrepreneurs, scientists, engineers – both as leaders and as principle contributors – working on the development of medical products and technology where I learn that they have never set foot in either the operating room, the diagnostic lab, or a cathlab. This is essential to truly experiencing and understanding the ecosystem in which their product will eventually reside and be used.

As a systems engineer, for me, everything appears as a system – a construct or collection of different elements that together produce results unobtainable by the elements alone.

The fun part - and difficult at the same time - is ensuring that as a company you invest accordingly to identify and understand those elements of the system which can affect your product.

In other words, with respect to medical device development and utilization, it is extremely important for developers, leaders and all those involved at one point or another, to truly understand and respect the lifecycle of the product itself and obtain a true understanding and appreciation of how, by whom, where, when the product can, will, could be used, abused, disposed, dropped, squeezed, looked at, interpreted, etc. - you get my drift.

The product in which your organization is pursuing will not be handled just by the surgeon or clinician, which you believe to be the only user. I guarantee you that it will, at one point or another, need to be held or taken out of its packaging by someone other than the user; be disposed of by someone other than the user; be purchased by someone other than the user; be interpreted for use by someone other than the user, and so on.

These are just examples of elements that can and will aid in validating your true needs for efficient and robust product development and utilization. Hopefully, all of these examples seem trivial and are already being considered.

If so, you can check some items off of your product development checklist. If not, then take the time to invest strategically in understanding and incorporating as much of the system into your product from the onset. Investigate the many ways in which you and your teams can gain access to the system – whether this is real-world operating exposure or making use of medical simulation tools and centres available to you.

Once you get access: observe, ask questions, and learn. Appropriately and effectively translate the new wisdom back to the bigger team. If you wait too long, you’re bound to have more surprises down the line than you would hope for.