Medical device advisory

Medical technology, examined at every layer.


BlackWind Technologies is the advisory practice of Dimitri Chernyak, Ph.D. For 25 years he has taken ophthalmic and photonics devices from first prototype to FDA and CE Mark, and helped acquirers see what lies beneath a deal.

25+
Years in medtech R&D
13
Issued U.S. patents
$20M
Acquisition diligence led
$10.1M
Venture capital raised

FDA / CE MARK / MDSAP / ISO 13485

Where BlackWind helps

Each practice comes from work Dimitri has led himself — inside Abbott, Johnson & Johnson Vision and VISX, and as chief executive of a venture-backed device company.Built on work Dimitri led himself — at Abbott, J&J Vision, VISX and as a medtech CEO.

New medical product development

From proof of concept to commercialization

Most device programs lose time between a working prototype and a product that can be certified, built and supported in the field. BlackWind helps teams make the decisions that shorten that path.

  • Feasibility review and technology roadmap
  • System architecture for opto-electro-mechanical and software devices
  • Design controls, DHF and V&V strategy (ISO 13485, FDA QMSR)
  • Risk management and usability (ISO 14971, IEC 62366)
  • Regulatory pathway for FDA, CE Mark and MDSAP
  • Design transfer, in-house manufacturing, field reliability
  • Fractional VP Engineering or COO leadership

OutcomeBuilding a practical strategy to achieve a faster go-to-market.

Technical due diligence for M&A

An independent engineering view before you sign

Financial and legal diligence can't tell you whether a technology works, can be cleared, or can be manufactured at scale. BlackWind gives acquirers and investors a clear technical answer.

  • Technology maturity and product readiness
  • Design history, quality system and regulatory status
  • Software, algorithms and cybersecurity posture
  • IP position and real technical differentiation
  • Manufacturability, supply chain and cost of goods
  • R&D team capability and key-person risk
  • Realism of roadmap, timeline and budget
  • Technical Feasibility & Risk Mitigation

DeliverableA written report with red flags, a risk matrix, and the cost and time to close each gap.

Ophthalmic devices

Opto-electro-mechanical and software systems

Refractive lasers, aberrometers and imaging systems combine precision optics, mechanics, electronics and software. Dimitri has built them for two decades.

  • Excimer and femtosecond refractive surgery systems
  • Wavefront aberrometry and optical modeling
  • Eye tracking, iris registration, image processing
  • Corneal biomechanics and Brillouin imaging
  • Pre-clinical and clinical studies with physicians
  • Technology landscape and partnership assessment

OutcomeSpecialist depth that generalist consultancies rarely have.

Along the whole optical path

Hands-on experience with the systems that measure the eye and the systems that treat it.

Refractive laser surgery

Wavefront-guided procedures, ablation algorithms and energy calibration for the STAR S4 IR.

Iris registration & eye tracking

Cyclotorsional tracking and registration methods, protected by issued U.S. patents.

Corneal biomechanics

The Brillouin-based BOSS platform, from prototype to CE Mark, launch and FDA clearance.

Diagnostic workstations

Next-generation refractive diagnostic workstation development at AMO.

Wavefront aberrometry

Fourier reconstruction methods used in the iDesign and WaveScan platforms.

Optical modeling

Ablation, laser-delivery and custom-lens aberration models, published in JOSA A and Applied Optics.

Two decades of ophthalmic systems at

VISX  /  AMO  /  Abbott Medical Optics  /  Johnson & Johnson Vision  /  Intelon Optics

How engagements work

From a single expert conversation to ongoing technical leadership. Fees are agreed per engagement.

FormatBest forScope
Advisory sessionA focused question or a second opinion1–2 hours, remote
ProjectA defined deliverable: assessment, architecture, V&V planFixed scope and timeline
Due diligenceA pre-deal technical assessmentTypically 2–4 weeks, written report
Fractional leadershipOngoing VP Engineering, CTO or COO supportMonthly retainer

Every engagement can be covered by an NDA from the first detailed conversation.

From first call to results

  1. Intro call15 minutes, free of charge. Your situation and what a good outcome looks like.
  2. ProposalScope, deliverables, timeline and fee in writing.
  3. The workHands-on, alongside your team, with regular check-ins.
  4. ResultsFindings and recommendations you can act on immediately.

An NDA can be in place from the first detailed conversation.

From first call to results

What happens after you book a call.

Portrait of Dimitri Chernyak, Ph.D.

Dimitri Chernyak, Ph.D.

Founder, BlackWind Technologies

Ph.D. in vision science (UC Berkeley), then two decades building refractive surgery and diagnostic systems at VISX, AMO, Abbott and J&J Vision. Since 2017 he has led Intelon Optics as VP Engineering, CEO and COO, and advises medtech startups as a Scientific Advisor and Board Member.

Dimitri earned a Ph.D. in vision science at UC Berkeley and spent the next two decades building refractive surgery and diagnostic systems at VISX, AMO, Abbott and Johnson & Johnson Vision.

Since 2017 he has led Intelon Optics as VP Engineering, CEO and COO, taking a novel imaging platform through certification, financing and commercial launch. He has also served as a Scientific Advisor and Board Member to multiple medtech startups, providing strategic guidance across technology development, clinical translation, and commercialization.

BlackWind brings that range — from algorithm to boardroom — to companies and investors who need a senior technical partner.

Education

  • Ph.D., Vision ScienceUC Berkeley
  • M.S., Cognitive and Neural SystemsBoston University
  • B.S., Mathematics and BiologyBrandeis University

Research

  • 13 issued U.S. patentsplus U.S. and international filings
  • Peer-reviewed publicationsIEEE TBME, JOSA A, Applied Optics, IOVS, JCRS
  • SpeakerAAO, ARVO, ESCRS, SPIE

Honors

  • NIH STTR Grant2021
  • AMO Patent of the Year2008, 2009, 2013
  • Abbott Award for Excellence2011
  • MassHealth Innovation Eddy AwardMedical device category

Tell us about your product or deal

A short description is enough to start. Every inquiry is confidential, and an NDA can be in place before the first detailed conversation.

Location
Greater Boston, Massachusetts — working with clients worldwide
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