Mark Howansky Email & Phone Number

Waltham, Massachusetts, Us

Responsible for building and managing a team responsible for all activities related to the development and launch of combination products (device constituent) and continuing commercial supply of medical device components and drug delivery systems. Partner with device technology firms to execute human factors design, development, and commercialization activities required to achieve Health Authority approvals. Lead all post-approval lifecycle management activities to maintain patient supply.

Lawrence Township, Nj, Us

• Managed team developing the device constituents of combination products for drug delivery and associated technologies, supporting both the pipeline of new drugs and lifecycle management of established brands by delivering against agreed upon Target Product Profiles (TPPs).• Collaborated with stakeholders to gather patient needs, determine portfolio requirements, perform options analyses, develop project plans with associated timelines and budgets, navigate governance structures. • Led first-in-class combination product oncology treatment program incorporating mechanical and digital elements through successful regulatory filings and recently-completed first patient treatment.• Oversaw multi-million dollar “home grown” innovation programs developing drug-delivery device solutions to address unmet user needs, with over ten patent applications filed to date.• Managed Human Factors Engineering (HFE) group responsible for all formative and summative studies.• Conducted technical assessments of commercially available drug-delivery device platforms.• Identified, onboarded and managed critical external partners including device component suppliers.

Lawrence Township, Nj, Us

• Built device development capabilities by driving projects, improving infrastructure and growing talent. Committed to the professional development of project team members, direct reports and interns/rotations.• Led cross-functional team responsible for all device constituent development and documentation supporting regulatory filings of novel combination product intended for at-home treatment. Provided inspirational management starting from project definition through regulatory approval and commercial transfer.• Managed human factors engineering sub-group responsible for formative and summative studies for all device development programs. Identified and on-boarded new human factors vendors with increased capabilities.• Oversaw multiple device innovation programs including cross-functional team members with both internal and external resources, resulting in ten filed patent applications.• Collaborated with Global Procurement and Legal to manage RFP process, resulting in multiple development contracts with total value >$10 million. • Organized technical assessments of high-volume drug delivery platforms. Created custom screening tools and tracking dashboard. Coordinated all steps from initial identification and non-confidential discussions, CDA execution, internal team formation, SOW definition, contracting, project management and reporting.• Supported Business Development and Drug Delivery Alliance Team as SME for due diligence efforts.• Designed and executed ergonomic study to inform design of manual syringe injection systems, which was published in award-winning scientific poster.• Developed and implemented system to measure in-line pressures during intra-tumoral drug delivery during clinical trials.• Improved department and company capabilities by embracing collaborative innovation mindset and integrating new tools and methods, such as: Agile project management, brainstorming techniques, and rapid prototyping.

• Led device development of combination products for the intervention of atherosclerotic diseases (minimally-invasive balloon-based drug delivery).• Generated complete design history files (DHF), including engineering inputs, design outputs (product specifications), design verification and validation, and risk analyses.• Designed and executed in-vivo and in-vitro testing to meet both existing standards and custom requirements.• Supplied support documentation to gain approval for successful 50 patient FIM clinical trial.• Developed IFU and educational materials and organized doctor training sessions. • Identified, selected and managed vendors responsible for various aspects of catheter manufacturing, including: balloon blowing, laser drilling, injection molding, machining, assembly and sterilization.• Oversaw operations to manufacture and supply devices to ten clinical study sites in four European countries.• Defined company strategy as part of leadership team.• Staffed and resourced Engineering department in start-up environment.• Managed project budgets and schedules with transparency to management board.• Implemented custom Design Control system, per FDA 21 CFR 820.30.

New Brunswick, Nj, Us

• Conducted detailed technology assessments for over 20 acquisition and investment targets across 4 different business units (women’s health, aesthetic medicine, ENT, and wound closure) to help drive go/no-go decisions. • Created technology landscapes to help identify potential growth opportunities in various clinical spaces including sleep apnea, female sterilization, abnormal uterine bleeding, uterine fibroids, laparoscopic hysterectomy, fecal incontinence and laparoscopic suturing.• Partnered with strategic marketing and R&D decision-makers to establish business development priorities, which led to more effective allocation of resources.• Negotiated four IP license agreements, enabling internal product development teams to access innovative technologies for male incontinence, female incontinence, pelvic organ prolapse and breast augmentation.• Crafted out-license agreement to generate potential revenue stream from latent patent.• Improved process for screening external product idea submissions, leading to shorter assessment times, more accurate tracking, more reliable archiving and higher yields (screened over 300 ideas).• Revamped department intranet site, creating a clear, organized, comprehensive online resource of critical forms, procedures and processes.• Trained R&D, Medical Affairs, Marketing, and Sales partners on New Business Development process, enabling more effective collaboration.

New Brunswick, Nj, Us

• Observed over 40 procedures as part of customer-focused field immersion, which uncovered unmet global user needs.• Led targeted innovation sessions using custom-developed techniques, which ultimately provided new product concepts for R&D.• Built proof-of-concept prototypes and conducted IP landscape analyses as part of viability test of lead designs.

New Brunswick, Nj, Us

• Managed a cross-functional team, while also serving as the lead designer for a mesh fastener instrument (PROFIX) which was patented, launched 12/05 and featured in a Design News magazine article (10/9/06).• Designed and developed new dispensing tips for a syringe-based flowable hemostat (SURGIFLO FlexTip and Endoscopic Applicator), both launched 8/06 and generated sales of $30MM/yr.• Provided key design contributions and was named on patent for flagship pelvic floor repair system (PROLIFT), which was launched 3/05, won 2006 MDEA award, and generated sales greater than $55MM/yr.• Designed novel vessel cutting device and deployment handle for precision anastomotic device system, and was named on two resulting patent applications.• Developed artificial urethral sphincter as part of urodynamic measurement system project (MONITORR), which was used for development and field training.• Managed junior-level engineers, enabling them to expand their skills while making tangible contributions.• Led team to identify and implement mechanical engineering best practices across company.• Performed technical due diligence to support New Business Development opportunity assessments.• Co-chaired 2005 R&D Conference, providing training and networking opportunities for over 300 Ethicon R&D associates.

Kalamazoo, Mi, Us

• Designed and developed innovative four instrument systems for joint replacement surgeries (Accolade-TMZF and Accolade-C Hip, Solar Shoulder, Trident Cup) based on user requirement derived from consultant surgeons. All products became category leaders.• Trained sales force and surgeons on product offerings, increasing their proper usage.• Collaborated with marketing as part of a unique organizational structure to co-manage all aspects of the product pipeline, spanning from identifying new product opportunities through mature product support.• Led task force that integrated the two legacy CAD systems post-merger, which reduced costs and standardized all design and documentation.

• Coordinated design work and testing required to launch transformational cardiac assist device, named on two issued patents. • Led team of designers, draftsmen and technicians to design the cuff implant component of a first-in-class cardiac assist device. • Managed relationships with contract suppliers of critical components in order to meet cost, time and quality requirements. • Built company's engineering infrastructure (CAD, drafting, and documentation systems) enabling robust mechanical design to take place, but in a cost-effective manner. • Identified rapid machining and prototyping vendors, which compressed development cycle times. • Presented project updates to leadership team, scientific advisory board, and current/potential investors to ensure that all company stakeholders were properly educated.

Minneapolis, Mn, Us

• Designed a disposable axial blood pump intended to replace traditional heart bypass machine, thereby reducing costs while improving clinical outcomes. Named on two resulting patents.• Developed a novel CAD/CAM process that enabled the design and manufacture of complex shapes for the pump impeller component.• Analyzed holding force of vascular clips to ensure that surgical device met design requirements. Data was also presented at the American Heart Association Scientific Session (11/95).

Minneapolis, Mn, Us

• Set-up production lines and trained assembly workers for five vascular surgery instruments, which were all successfully transferred to large-scale manufacturing.

Greenville, South Carolina, Us

• Conducted in-country primary market research of Ukrainian aerosol valve industry, providing critical information to American company looking to enter market.

Ba, Engineering Sciences

Mba, Dual Major: Management And Information Systems

High School Diploma, General Studies

Master Of Business Administration - Mba

Master Of Business Administration - Mba