Michael Bielski

Medical device & biotech entrepreneur. Founder @DevTechPartners, @Capseus & @NewLeaf_Sym.

[Capseus @capseus]

See why the Capseus BDC-15 is the premier autograft colletion device!

Highest Volume Collections - Superior Graft Quality - No setup time - No additional equipment needed - No added time or interuption to your workflow - Collect UNLIMITED amounts of autograft per case:

[Michael Bielski @MichaelBielski]

So proud of the @capseus team and the momentum we are building with the BDC-15. More exciting things to come!

[Capseus @capseus]

THANK YOU @spinesection & @TGHCares for hosting the Spine Summit Conference last weekend in Tampa! Capseus had a great show & we look forward to working with our new surgeons & account connections nationwide! #Spinesummit #Capseus #autograft the #goldstandard in #spinesurgery

[Center for Biotech @Center4Biotech]

Still time to register for the @nihseed SBIR/STTR webinar tomorrow (11/13)! Details below!⬇️

[NewLeaf Symbiotics @NewLeaf_Sym]

Early harvest results look promising for our EPA-registered corn rootworm bioinsecticide. Growers saw better standability, protection against CRW and abiotic stress, larger root mass and root regrowth if plants had corn rootworm pressure. Fun Fact: it comes with a built-in insurance policy – our PPFM-based corn biostimulant. So, whether growers see CRW or not, they see an advantage with #PinkPerformance. #Yield #AgInnovation

[NewLeaf Symbiotics @NewLeaf_Sym]

Hard work, dedication and meticulous planning pave the way for the pursuit of excellence in both agriculture and NASCAR racing. Our CTO Dr. Shawn Semones and @RossChastain discuss their commitment to advancing innovative solutions. 🏆 #PinkPerformance #NASCAR #AgInnovation

[Michael Bielski @MichaelBielski]

Had a great time talking about biomedical engineering, IP strategy and entrepreneurship with @crubin108 and his BME 505 class today at @stonybrooku . Always great being on campus!

[Michael Bielski @MichaelBielski]

Amazing launch of the @Capseus BDC-15 at @NASSspine!

Years of work and support from @DukalHealth validated by unbelievable feedback and product requests. Our new team absolutely crushed it. So much more to come. #autograft

[Michael Bielski @MichaelBielski]

Medical devices are really just a collection of individual user needs that each require a solution.

Break those user needs down. Immerse yourself in the disease state and current gold standard.

Make sure your compiled solution can improve outcomes and lower costs.

[Michael Bielski @MichaelBielski]

I see this mistake all the time: No time for Q&A and discussion during a licensing or partnering pitch.

Why is this a problem? Your #1 job is to figure out what the hurdles are to get to the next meeting and address them.

Don't waste the whole meeting presenting slides.

[Michael Bielski @MichaelBielski]

Podcasts are now the most valuable content I consume, by far.

Our ability to listen in to conversations previously reserved for a select few is such a game-changer.

You are falling behind if you aren't listening to 2 or 3 podcasts a week in your areas of interest.

[Michael Bielski @MichaelBielski]

2/2 Break down and prioritize critical device features (cutting vs. sensing vs. materials vs. size, etc.) and build experiments to test them individually.

Eventually, you will have mitigated enough risk to test the features all together in a more refined prototype.

[Michael Bielski @MichaelBielski]

1/2 Proof-of-concept is a critical value-driving milestone for any medical device project.

In early R&D/feasibility, sometimes it's tough (and expensive) to validate every technical feature of the design in the same experiment.

But, we need to make progress.

[Michael Bielski @MichaelBielski]

Understanding the current clinical gold standard and workflow is just as important as understanding how your proposed medical device works.

Validate your problem in the literature and with customer discovery before investing in expensive prototypes and patent conversions.

[Michael Bielski @MichaelBielski]

For startups: Long-term value from your IP portfolio is a function of how much is disclosed to IP counsel.

Don't limit your disclosure only to what you think is patentable.

Disclose everything you think is important and your IP team will filter. More is better.

[Michael Bielski @MichaelBielski]

The compounding effect of networking is real.

It is amazing how one seemingly random interaction can eventually lead to a valuable introduction or an opportunity. Maybe even years later.

Treat every new conversation with that in mind.

[Michael Bielski @MichaelBielski]

Many medical device inventors and entrepreneurs fail because they skip doing real customer discovery.

Hearing how other stakeholders feel about your hypothesis is going to happen at some point anyway.

Don't learn about fatal flaws you could have fixed during due diligence.

[Michael Bielski @MichaelBielski]

"Patent Licensing" is about pitching an exciting, risk-mitigated business opportunity to an investor (your licensee).

If they like the opportunity, due diligence will then see if patents protects it.

The license doesn't start with the patent, but a bad patent can end it.

[Michael Bielski @MichaelBielski]

Medical device development "waterfall" figure (from FDA's "Design Control Guidance for Medical Device Manufacturers").

Remember, it is just a model.

Lots of real-world feedback missing here, but all medical device inventors & researchers should know this figure in detail.

[Michael Bielski @MichaelBielski]

Couldn't agree with this more.

Do your homework, validate the (clinical) problem and your proposed solution (medical device).

[Martin Tobias (Pre-Seed VC) @MartinGTobias]

Startups aren’t always about being first. They’re about being the best.

Be it in functionality, user experience, or market fit.

Don't just strive to be first out of the gate. Strive for value.

[Michael Bielski @MichaelBielski]

It will be interesting to see how the recent emphasis on revenue-traction by VCs will affect investments in medical devices, biotech & pharma.