Greg Halstead, Ms Email & Phone Number

• Experienced leadership with cross-functional communicative ability to gain consensus, convey complex ideas & information, and establish pathways to drive projects to a successful completion. Proven executive track.
• Specializing in product manufacturing efforts through design, testing, refinement and ramp in regulated industries.
• Conducting both product design & development efforts along with market research & analysis.
• Building project plans and budgets while outlining requirements for compliance to design and industry standards, including: ISO 10993, 13485 and 14971; FDA CDRH; EU MDR for Class II & III medical devices.
• Developing IP strategy and reviewing/editing filings for USPTO patent applications.
• Assisting with the development of funding strategies in the Medical Device industries through Venture Capitalist and Angel sources.

El Dorado Hills, CA, US

Program management for a 510(k) Class II device to include: system design; testing; and production transfer.

Design transfer and manufacturing ramp-up for clinical and commercial use of pharmacologic products.

Tampa, Florida, US

Patent drafting for USPTO filings.

Sewickley, PA, US

Logistical and operational guidance & support for manufacturing facilities.Navigation of regulated industries and completion of testing & validations.

San Francisco, US

San Diego, CA, US

Facilitated design transfers, document reviews and production ramp with associated testing for pilot production.Restructured and equipped test labs areas for completion of V&V for Regulatory filings for Insulin Dispense. Data collection and analysis was paramount to IFU & 510(k) application.

Class III medical device for spinal disc injections. Used to bulk up the disc to alleviate pressure on the nerve.Completing segue to volume production in support of Clinical Studies and CE MDR Certifications.Establishing manufacturing documentation and technology transfers.Conducting test protocols and associated V&V reporting. Working with contract.

• Pre-revenue direct to consumer product lineup for visual wellness.Leveraging background in ophthamology, working to design, develop and launch novel devices for improved visualization.
• Conducting consumer testing based on prototype designs.
• Completing design-for-manufacturing and working with contract manufacturers & designers for early product release & commercialization. (to include packaging, fulfillment, scalability)
• Establishing testing protocols: for both product design and consumer use conditions.
• Strategic direction for fund raising and product launch strategy.

Modiin, Israel, IL

We were developing the US market for a vision wellness using neuro-stimulation. With a CPT III code approved for amblyopia and USFDA 510(k) clearance, program introductions and awareness were initiated.Initiated marketing & commercialization efforts, CPT coding physician programs & worked to establish a sales division for US operations.

• We started a medical-device start-up for intravascular imaging using existing technologies applied in a novel manner. From Corporate Strategy, Funding Roadshows, Market research, Device Design & Development: it was a.
• Outlined development programs, milestones and timelines for device fabrication. Organized suppliers & vendors for production transfer and ramp.
• Conducted several group pitch sessions and additional individual and corporate meetings. Presented to private equity, venture and corporate investment communities for seed-round funding. Currently negotiating with.

Sunnyvale, CA, US

• Employee #1 at a Medical Device start-up for Class II/IIa balloon microcatheters; leveraged engineering, research, business, clinical and regulatory skills & experiences to expedite product introductions in the.
• Generated 80% adoption with a therapeutic paradigm shift from palliative to curative care by merging 2 technologies into a new life-saving catheter design.
• Conducted animal-based research to help prove fundamental design mechanism of action and mimic use in clinical practice.
• Wrote and obtained two FDA Clearances with Traditional 510(k) filings.
• Submitted 8 patents for catheter design and development from review of laboratory and manufacturing processes, strengthening portfolio for acquisition.MANUFACTURING AND OPERATIONS
• Validated the product transfer from the initial 10-20 R&D units/mo to >500 production units/mo by refining design for manufacturing, establishing processes, and writing manufacturing instruction sets with associated.

• Home Owners Association for our local community.
• Established tax exemption status for Federal and California filings.
• Assess and established budgets for the community.
• Was the primary lead for contact, support, guidance for people within the community. Ensured home and/or city questions were answers and provided assistance where needed on home maintenance or community events.

Oakland, New Jersey, US

• Newly formed medical laser division (post acquisition) of a large corporate entity with products in optics & materials, construction, agriculture and medical devices. Over 5000 employees with over 60 subsidiaries..
• Managed R&D efforts within Research, Software, Development, Product Support/Manufacturing Engineering for global commercialization of Class IV Laser systems for Class II/IIa medical devices.
• Established global strategies for product introductions based on Sales, Marketing, Compliance and Regulatory schedules.
• Delivered on-time project to meet corporate sales objectives.
• Developed design processes inclusive of time tracking, project costing and manufacturing efforts.
• Managed patent efforts and work with legal teams for regional applications, divisional and/or continuing applications.

Oakland, New Jersey, US

• Directing engineering efforts based on market trends. Development of global marketing strategies and managed sales channels within Europe, Central/South America, Asia and Canada.
• Developed product and R&D strategies for new product initiatives and product revisions.
• Re-launched product portfolios with added public relations efforts to speed acceptance in publications and podium time at key conferences.
• Performed corporate branding to re-identify product branding and association with Topcon.
• Designed and conducted live and web-based training sessions for product introductions with sales personnel and physician development for clinical utility.
• Developing sales channels by adding distributors in key countries. Working with corporate Regulatory, distributors and foreign government standards to register medical products for importation and sale.

Mountain View, California, US

• Directed marketing and engineering efforts for ophthalmic, otolaryngolic and veterinary business units, inclusive of product portfolio, corporate strategy, new product development and sales strategies.
• Directed R&D new product initiatives from concept through launch, based on sales, market and clinical needs.
• Completed and managed design criteria for the launch of 3 capital equipment devices for both office and operating room use. Used new technology to drive adoption with new clinical capability, establishing key.
• Responsible for design and development strategies for over 20 consumable instruments launched into surgical markets for operating room use.
• Developed physician relationships to leverage public relations efforts in order to maximize clinical presence on the podium and presentation circuits.
• Managed P&L for both disposable and capital equipment product lines across multiple markets.

US

• Led product introduction efforts to build market acceptance and structured sales, customer and clinical training programs to facilitate a standard of care for instrument utility.
• Conducted post-market clinical surveillance to gauge efficacy data with reports and presentations to both executive staff and board of directors.
• Integrated AdvaMed guidelines into corporate policy and procedure.
• Outlined product improvements and future iterations of current designs based on market need and product performance in situ with clinical data.
• Formed relationships with KOLs to further understand market dynamics to aid in product introductions and adoption.

Yokne'am Ilit, Tsafon, IL

• Introduced new equipment and alternate means of medical therapy and implemented programs to establish a standard of care working with the medical community, public relations and clinical education programs.
• Lead product planning strategies and design groups to launch a series of capital equipment medical systems. Targeted introductions to United States, Japan, China, India and European territories differed by market needs.
• Wrote business plans to justify and hire marketing professionals for ophthalmic product lines to further support corporate sales initiatives.
• Developed KOL relations and introduced new public relations programs to increase publications, podium presence and general awareness of clinical use throughout the ophthalmic community.
• Organized and conducted periodic training programs for internal sales and clinical groups as well as external physician audiences.
• Directed $60M division though corporate reorganization and aligned R&D efforts on new product introductions to prioritize

US

• Leveraged a multi-disciplinary background, advanced from engineering responsibilities to business and marketing for clinical and physician applications. Accomplishments
• Core team member for new product design, development and introductions. Responsible for evaluation and testing of emerging technologies for incorporating into product portfolios.
• Managed engineering and clinical teams for project-based product introductions
• Led R&D projects from design though manufacturing. One such successful and timely completion resulted in $6.5M in additional recognized revenue for the quarter.
• Responsible for conducting training programs and knowledge transfer directed toward internal groups (sales, marketing, clinical training and physician medical monitors).
• Designed and conducted experiments and developed processes to improve response times for FDA PMA applications, from product explanations to clinical data assessment.

US

Master Of Science - Ms, Biomedical Engineering

Bachelor Of Science - Bs, Biomedical Engineering

Marketing Strategy