“Mark is one of the best project team leaders, quick learners, and innovators I’ve encountered over my 38 years in the pharma and device industries (as well as being an all-around nice and caring person). He has successfully led both early design and late product development efforts in the combination product space, most recently bringing a product to Phase 3 clinical readiness. He’s a creative problem solver, and understands how best to work with and manage colleagues at all levels of experience. Mark has a great career ahead of him!”
Mark Howansky
Basking Ridge, New Jersey, United States
3K followers
500+ connections
About
I am a dynamic, creative and collaborative engineer with a twenty-five+ year history of…
Activity
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The war rages on. Russia continues to bomb and kill civilians. Locally I hear a lot of people talk about money going to Ukraine and complaints…
The war rages on. Russia continues to bomb and kill civilians. Locally I hear a lot of people talk about money going to Ukraine and complaints…
Liked by Mark Howansky
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J&J reunion with Chanaka Amarasinghe and Matthew Krever, PMP Great catching up guys!
J&J reunion with Chanaka Amarasinghe and Matthew Krever, PMP Great catching up guys!
Shared by Mark Howansky
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Last week, we held our Product Development Town Hall at our Devens, Massachusetts development and manufacturing site. I had the privilege of…
Last week, we held our Product Development Town Hall at our Devens, Massachusetts development and manufacturing site. I had the privilege of…
Liked by Mark Howansky
Experience
Education
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Harvard University
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Activities and Societies: Varsity Soccer (All-Ivy League), Intramural Ice Hockey
Mechanical engineering curriculum with specialty in biomedical engineering.
Graduated cum laude. -
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Activities and Societies: Soccer, Ice Hockey, Lacrosse, Track&Field, National Honor Society
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Licenses & Certifications
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Drug-Device Combination Products: Quality & Regulatory Requirements
Symmetric Training (Professional Training & Coaching)
Volunteer Experience
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National President
Organization for the Defense of Lemko Western Ukraine (OOL)
- Present 11 years
Education
OOL is a national organization with eight active regional branches, whose mission is to organize Lemko Ukrainians in their communities, foster their language and traditions, conduct cultural and educational work, and provide humanitarian support to natives of the Lemko region and their descendants, including donating financial assistance to schools, churches, artistic ensembles, and educational institutions.
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Board Of Advisors
U.S.-Ukraine Foundation
- Present 7 years 2 months
Economic Empowerment
The U.S.-Ukraine Foundation is a U.S. 501(c)(3) nonprofit, nongovernmental organization established in 1991 to support democracy, a free market and human rights for Ukraine. The Foundation creates and sustains an exchange of information between the United States and Ukraine in order to build peace and prosperity. The Foundation is dedicated to strengthening U.S.-Ukraine relations and therefore the mutual objectives of both nations, advancing Ukraine as a cornerstone of regional stability and…
The U.S.-Ukraine Foundation is a U.S. 501(c)(3) nonprofit, nongovernmental organization established in 1991 to support democracy, a free market and human rights for Ukraine. The Foundation creates and sustains an exchange of information between the United States and Ukraine in order to build peace and prosperity. The Foundation is dedicated to strengthening U.S.-Ukraine relations and therefore the mutual objectives of both nations, advancing Ukraine as a cornerstone of regional stability and as a full partner in the community of nations.
Publications
Patents
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System and Method for Surgical Implant Placement
Issued US 7,527,588
A system and method for placing surgical implants and having particular application for pelvic floor repair. The system includes an assembly having a guide element with a tissue penetrating tip, a cannula, and a retrieval device having a capture element at its distal end. A channel in the cannula is dimensioned to allow passage therethrough of the guide element, and of the retrieval element when removably coupled with an extension of the surgical implant.
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System for Holding Surgical Fasteners
Issued US 7,452,368
A system for holding surgical fasteners each having a first anchor, a second anchor and a connector extending therebetween upwardly from the first and second anchors, and a method for loading the same into an applicator. The system includes a shuttle having first and second channels dimensioned to slidably receive therein the first and second anchors, and having first and second grooves respectively forming openings into the channels along a portion of a length of the channels. When the first…
A system for holding surgical fasteners each having a first anchor, a second anchor and a connector extending therebetween upwardly from the first and second anchors, and a method for loading the same into an applicator. The system includes a shuttle having first and second channels dimensioned to slidably receive therein the first and second anchors, and having first and second grooves respectively forming openings into the channels along a portion of a length of the channels. When the first and second anchors are received within the first and second channels, the connector of the surgical fastener extends out of the shuttle through the first and second grooves. The system also includes a cartridge having at least a first channel dimensioned to slidably receive the shuttle therein, and having a first projection extending into the first channel. When the shuttle and loaded fastener are received within the cartridge channel, the connector of the surgical fastener abuts the first...
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Circulatory Support System
Issued US 6,716,189
A method for providing at least partial bypass of the heart to supplement the pumping function of the heart to thereby enable the surgeon to perform various surgical procedures thereon includes providing a circulatory assist system having a portable extracorporeal axial flow pump with a pump housing, a rotating pumping member disposed in the pump housing and inlet and outlet cannulated tubes respectively connected to inlet and outlet ports of the pump housing, accessing the patient's left…
A method for providing at least partial bypass of the heart to supplement the pumping function of the heart to thereby enable the surgeon to perform various surgical procedures thereon includes providing a circulatory assist system having a portable extracorporeal axial flow pump with a pump housing, a rotating pumping member disposed in the pump housing and inlet and outlet cannulated tubes respectively connected to inlet and outlet ports of the pump housing, accessing the patient's left atrium of the heart with the inlet cannulated tube, accessing the aorta with the outlet cannulated tube, actuating the rotating pumping member to draw oxygenated blood from the left atrium of the heart through the lumen of the inlet cannulated tube and into the inlet port of the pump housing whereby the pumping member imparts mechanical energy to the oxygenated blood passing through the pump housing and directs the oxygenated blood through the outlet port and through the lumen of the outlet...
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Circulatory Support System
Issued US 7,264,606
A method for providing at least partial bypass of the heart to supplement the pumping function of the heart to thereby enable the surgeon to perform various surgical procedures thereon includes providing a circulatory assist system having a portable extracorporeal axial flow pump with a pump housing, a rotating pumping member disposed in the pump housing and inlet and outlet cannulated tubes respectively connected to inlet and outlet ports of the pump housing, accessing the patient's left…
A method for providing at least partial bypass of the heart to supplement the pumping function of the heart to thereby enable the surgeon to perform various surgical procedures thereon includes providing a circulatory assist system having a portable extracorporeal axial flow pump with a pump housing, a rotating pumping member disposed in the pump housing and inlet and outlet cannulated tubes respectively connected to inlet and outlet ports of the pump housing, accessing the patient's left atrium of the heart with the inlet cannulated tube, accessing the aorta with the outlet cannulated tube, actuating the rotating pumping member to draw oxygenated blood from the left atrium of the heart through the lumen of the inlet cannulated tube and into the inlet port of the pump housing whereby the pumping member imparts mechanical energy to the oxygenated blood passing through the pump housing and directs the oxygenated blood through the outlet port and through the lumen of the outlet...
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Method and Apparatus for Assisting a Heart to Pump Blood
Issued US 6,238,334
A ventricular cuff is designed to assist a heart to pump blood by applying uniform pressure to a majority portion of an exterior ventricular surface of the heart. A heart engaging structure is preferably provided for releasably engaging the heart to hold the heart in place relative to the cuff. The ventricular cuff includes an outer shell, an inflatable inner bladder and a fastener assembly. The heart engaging structure and ventricular cuff define an upwardly opening chamber sized for receiving…
A ventricular cuff is designed to assist a heart to pump blood by applying uniform pressure to a majority portion of an exterior ventricular surface of the heart. A heart engaging structure is preferably provided for releasably engaging the heart to hold the heart in place relative to the cuff. The ventricular cuff includes an outer shell, an inflatable inner bladder and a fastener assembly. The heart engaging structure and ventricular cuff define an upwardly opening chamber sized for receiving a heart. The bladder has an opening for communication with a source of fluid under pressure so that the bladder is cyclically inflated and deflated at a predetermined rate to assist the ventricles of the heart to properly contract.
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Circulatory Support System
Issued US 5,965,089
A method for providing at least partial bypass of the heart to supplement the pumping function of the heart to thereby enable the surgeon to perform various surgical procedures thereon includes providing a circulatory assist system having a portable extracorporeal axial flow pump with a pump housing, a rotating pumping member disposed in the pump housing and inlet and outlet cannulated tubes respectively connected to inlet and outlet ports of the pump housing, accessing the patient's left…
A method for providing at least partial bypass of the heart to supplement the pumping function of the heart to thereby enable the surgeon to perform various surgical procedures thereon includes providing a circulatory assist system having a portable extracorporeal axial flow pump with a pump housing, a rotating pumping member disposed in the pump housing and inlet and outlet cannulated tubes respectively connected to inlet and outlet ports of the pump housing, accessing the patient's left atrium of the heart with the inlet cannulated tube, accessing the aorta with the outlet cannulated tube, actuating the rotating pumping member to draw oxygenated blood from the left atrium of the heart through the lumen of the inlet cannulated tube and into the inlet port of the pump housing whereby the pumping member imparts mechanical energy to the oxygenated blood passing through the pump housing and directs the oxygenated blood through the outlet port and through the lumen of the outlet...
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Drug Cartridge, Drug Delivery Devices, and Methods for Preparing Thereof
Filed WO2022261540A2
In one aspect, a method is provided herein of preparing a drug delivery device, the drug delivery device having a body with at least one fluid duct being open along a first face of the body, the at least one fluid duct for conveying drug from at least one reservoir to a needle configured for injection into a patient, the method including: providing a barrier across the first face of the body to at least cover the at least one fluid duct, wherein the barrier is ultraviolet transmissive; and…
In one aspect, a method is provided herein of preparing a drug delivery device, the drug delivery device having a body with at least one fluid duct being open along a first face of the body, the at least one fluid duct for conveying drug from at least one reservoir to a needle configured for injection into a patient, the method including: providing a barrier across the first face of the body to at least cover the at least one fluid duct, wherein the barrier is ultraviolet transmissive; and, exposing the first face of the body to ultraviolet radiation so as to allow the ultraviolet radiation to pass through the barrier and decontaminate the at least one fluid duct.
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Drug cartridge, drug delivery device, and methods for preparing thereof
Filed WO2022261543A2
In one aspect, a drug delivery device is provided herein including: a monolithic body having a plurality of fluid ducts and at least one outlet duct formed therein; a plurality of drug cartridges attached to the body, the drug cartridges each including a reservoir for accommodating at least one drug wherein, the plurality of fluid ducts is arranged to convey the drugs from the drug cartridges to the at least one outlet duct; and, a needle support spaced from the body, the needle support…
In one aspect, a drug delivery device is provided herein including: a monolithic body having a plurality of fluid ducts and at least one outlet duct formed therein; a plurality of drug cartridges attached to the body, the drug cartridges each including a reservoir for accommodating at least one drug wherein, the plurality of fluid ducts is arranged to convey the drugs from the drug cartridges to the at least one outlet duct; and, a needle support spaced from the body, the needle support including a needle configured for insertion into a patient for drug delivery, the needle support including adhesive for releasable securement to a patient, wherein, the needle support is connected to the body by a flexible tether through which passes at least one fluid passageway formed to convey drug from the at least one outlet duct to the needle.
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Alternative fluidic pathing for serially connectable drug modules
Filed WO2021092578A2
Various embodiments are disclosed herein related to fluidic connections for modules useable in combinatorial drug delivery devices. The fluidic connections allow for variable flow paths to be defined for serially-connected, and base-tray mounted, modules.
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Piston valving for serially connectable drug modules of a combinatorial drug delivery device
Filed WO2021092534A1
A valving arrangement is provided herein for regulating fluidics of modules useable in a combinatorial drug delivery device. The valving includes a slidable piston valve, adjustable to selectively seal an outlet path from a drug vial and a sealing port, in parallel to a vent, for selectively sealing an inlet path to the drug vial. Advantageously, the subject invention allows for applied negative pressure to adjust the valving to allow flow between serially-connected modules forming a drug…
A valving arrangement is provided herein for regulating fluidics of modules useable in a combinatorial drug delivery device. The valving includes a slidable piston valve, adjustable to selectively seal an outlet path from a drug vial and a sealing port, in parallel to a vent, for selectively sealing an inlet path to the drug vial. Advantageously, the subject invention allows for applied negative pressure to adjust the valving to allow flow between serially-connected modules forming a drug delivery device.
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Radially adjustable multi-cartridge combinatorial drug delivery device for subcutaneous injection
Filed WO2021092558A1
In one aspect, a drug delivery device is provided for delivering drug from a plurality of drug cartridges. The drug delivery device includes: a cylindrical cassette configured to accommodate the plurality of drug cartridges; a reversibly advanceable plunger; and, an indexer for incrementally rotating the cassette to align the plurality of drug cartridges individually with the plunger. The indexer includes first and second shafts with cooperating elements which cause incremental rotation of the…
In one aspect, a drug delivery device is provided for delivering drug from a plurality of drug cartridges. The drug delivery device includes: a cylindrical cassette configured to accommodate the plurality of drug cartridges; a reversibly advanceable plunger; and, an indexer for incrementally rotating the cassette to align the plurality of drug cartridges individually with the plunger. The indexer includes first and second shafts with cooperating elements which cause incremental rotation of the first shaft, relative to the second shaft, upon the second shaft engaging the first shaft.
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Serially-connectable drug modules for combinatorial drug delivery device
Filed WO2019217845A1
A combinatorial drug delivery device is provided for delivering a predetermined selection of drug components, each of the drug components being contained in a drug vial. The device includes a plurality of modules, wherein each of the modules includes: a body having an interior volume formed to accommodate a drug vial; a cannula protruding into the interior volume, the cannula terminating at a free end, first and second openings being formed in the free end with first and second lumens extending…
A combinatorial drug delivery device is provided for delivering a predetermined selection of drug components, each of the drug components being contained in a drug vial. The device includes a plurality of modules, wherein each of the modules includes: a body having an interior volume formed to accommodate a drug vial; a cannula protruding into the interior volume, the cannula terminating at a free end, first and second openings being formed in the free end with first and second lumens extending therefrom and through the cannula; a socket located on an exterior portion of the body; a first passageway extending between, and in communication with, the socket and the first lumen; a boss protruding from an exterior portion of the body; and, a second passageway extending from, and in communication with the second lumen, the second passageway extending through the boss to terminate at an exit opening formed therein.
Languages
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Ukrainian
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Spanish
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Organizations
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Harvard Varsity Club
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- Present -
American Society of Mechanical Engineers (ASME)
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Recommendations received
12 people have recommended Mark
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Today, my favorite ophthalmologist, Lauren Ciulla, MD, an ophthalmology resident at The University of Chicago, presented at The Women in…
Today, my favorite ophthalmologist, Lauren Ciulla, MD, an ophthalmology resident at The University of Chicago, presented at The Women in…
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I just completed my first day with an Intraocular lens, a technology I've worked with since my grad school days in 1977. Thanks to Dr. Stephen…
I just completed my first day with an Intraocular lens, a technology I've worked with since my grad school days in 1977. Thanks to Dr. Stephen…
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We moved earlier this month to a beautiful new office down the hall! The serene views of the Charles River are perfect for the summer, as are…
We moved earlier this month to a beautiful new office down the hall! The serene views of the Charles River are perfect for the summer, as are…
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Please see new Global Business Process Owner role for Devices at GSK, and share with your networks. Thank you! https://lnkd.in/eeNdD7yq
Please see new Global Business Process Owner role for Devices at GSK, and share with your networks. Thank you! https://lnkd.in/eeNdD7yq
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I decided NOT to pass the bar. Instead, after I finished taking the bar exam, I stopped off for a well deserved Jameson’s Irish Whiskey. Hopefully,…
I decided NOT to pass the bar. Instead, after I finished taking the bar exam, I stopped off for a well deserved Jameson’s Irish Whiskey. Hopefully,…
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Yesterday, we had the pleasure of hosting NSF REU BioSMART students from the New Jersey Institute of Technology - https://lnkd.in/eNPX4b6x at the…
Yesterday, we had the pleasure of hosting NSF REU BioSMART students from the New Jersey Institute of Technology - https://lnkd.in/eNPX4b6x at the…
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I'm hiring an Associate Director of Device Development and Manufacturing. Apply here: https://lnkd.in/ecMmUH4t
I'm hiring an Associate Director of Device Development and Manufacturing. Apply here: https://lnkd.in/ecMmUH4t
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Pharma Partnering Summit is delighted to introduce Pat Albert Fetaya, Head, US Business Development at Servier Pharmaceuticals as a Panelist at…
Pharma Partnering Summit is delighted to introduce Pat Albert Fetaya, Head, US Business Development at Servier Pharmaceuticals as a Panelist at…
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Excited to join the board of Jishu Tech Hub A couple of weeks ago, while on a trip to Lagos, Nigeria, I spent some time at the headquarters of the…
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