Greg Halstead, Ms Email and Phone Number
Medical Device Design & Development | Product Commercialization | Engineering & Operations Executive | Manufacturing Ramp | NPI | Entrepreneur at
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EMED Technologies Corporation
Greg Halstead, Ms's Location
Carlsbad, California, United States, United States
Greg Halstead, Ms's Contact Details
Greg Halstead, Ms work email
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Greg Halstead, Ms personal email
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Greg Halstead, Ms phone numbers
About Greg Halstead, Ms
✉️ gregdhalstead+LI@gmail.com ☎︎ +1-760-593-4403I'm a strategic and engaging Engineering & Operations Executive with focus and insight on product introductions (0-1 / from concept through launch). Please reach out - happy to connect!DIVERSE BACKGROUNDWith multidisciplinary work experience in science, engineering, clinical research, quality/regulatory assurance, and business, I leverage key insights to bring groups together and guide product strategy efforts while working with customers to better drive development and testing.MY EXPERTISE INCLUDES🎯 Design, Development & Regulations: Technical and Business leadership demonstrated with >15 medical device family introductions (concept through launch).🎯 Operations: Quality Systems, Manufacturing transfer and ramp. Launched 15 products (concept through launch) as capital equipment, disposables and instrumentation from both Marketing & Engineering capacities. 🎯 Corporate Strategy: Participated with 6 corporate M&A efforts with both acquisition and sales; including perspectives from engineering, operation, marketing and regulatory.🎯 Start-up & Large-companies: Leadership experience in organizations from 1 to over 5000 people; growing teams and organizing consensus among cross-functional groups.🎯 Patent & IP Strategy: Inventor on 5 patents (plus pending); managed IP Strategy. Submitted over 2-dozen patents by architecting corporate programs to reward patent filings. CAREER PATHWAY & BACKGROUNDI started as an engineer working in a laboratory setting and soon moved to applications work in the field. This permitted travel with sales and marketing groups, meeting physicians and working with nurses and clinical trainers. Once having a taste of field operations, I joined marketing, gaining business acumen. Eventually I transitioned back to Engineering with Operational roles to manage both R&D and Manufacturing groups. Responsibilities for Operations included greater emphasis on Quality and Regulatory requirements.I bring a unique perspective from many disciplines, essentially functioning as a translator between groups: engineering; sales; physicians; marketing; clinical; and regulatory are all fluent to me.
Greg Halstead, Ms's Current Company Details
Emed Technologies Corporation
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Medical Device Design & Development | Product Commercialization | Engineering & Operations Executive | Manufacturing Ramp | NPI | Entrepreneur
Greg Halstead, Ms Work Experience Details
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Operations And Engineering Executive, Medical Device ConsultantEngineering & Operations Executive 2020 - PresentExperienced 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 record specializing in product introductions.• 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.• Networking with designers, manufacturers, assemblers, supplier and vendors.I look forward to speaking with you!
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System Engineering / AdvisorEmed Technologies Corporation 2024 - PresentEl Dorado Hills, Ca, UsProgram management for a 510(k) Class II device to include: system design; testing; and production transfer.
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Sr Director, ManufacturingPropedix Inc 2024 - PresentDesign transfer and manufacturing ramp-up for clinical and commercial use of pharmacologic products. -
Patent WriterMenlo Park Patents 2022 - PresentTampa, Florida, UsPatent drafting for USPTO filings. -
Subject Matter Expert - Operations & ManufacturingTenzing 2021 - PresentSewickley, Pa, UsLogistical and operational guidance & support for manufacturing facilities.Navigation of regulated industries and completion of testing & validations. -
Ai Trainer - Biomedical EngineeringOutlier 2023 - 2024San Francisco, Us -
Director Of Product DevelopmentModular Medical, Inc. 2023 - 2023San Diego, Ca, UsFacilitated 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. -
Vp Of Engineering And Product DevelopmentSpineovations, Inc. 2022 - 2023Class 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 manufacturing to manufacture devices for clinical studies. -
Vice President, Strategy & Product DevelopmentNearsight 2021 - 2023Pre-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. -
Manager, UsaRevitalvision 2021 - 2022Modiin, Israel, IlWe 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. -
Chief Operating Officer | Co-Founder | EntrepreneurOptimint 2020 - 2022We 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 core example of wearing many hat and juggling everything as required.• 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 Investors and Corporate partners regarding funding opportunity.
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Engineering & Operations Executive | Product Design & Development, Regulatory & ManufacturingEmbolx, Inc. 2014 - 2020Sunnyvale, Ca, UsEmployee #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 regulated medical industry. Responsible for corporate operations, engineering, manufacturing, regulatory and quality groups. Reported to CEO.MEDICAL DEVICE DESIGN & DEVELOPMENT• 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 testing and training. • Established contracts and agreement for contract manufacturing and/or development facilities.• Organized corporate workflow from finished goods to distribution and shipping.CORPORATE COMPLIANCE | REGULATORY AND QUALITY SYSTEMS• From scratch, created a document control and Quality system for FDA clearance, Canadian CMDCAS and CE Certification to EN/ISO 13485 & 14971. • Transitioned certifications for ISO 13485:2016 along with gap analysis and project outlines to transition from EU MDD to MDR.• Maintained corporate compliance in all functional areas, such as: R&D Documentation & Calibration; Sterilization; Bioburden; FDA/CE Audits. -
PresidentFerndale Glen Maintenance Association 2004 - 2019Home 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.
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Research & Development Director | Product Planning, Testing, Manufacturing TransfersTopcon Medical 2011 - 2014Oakland, New Jersey, UsNewly 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. Reported to division Chief Executive Officer; managed team of 18 people.ACCOMPLISHMENTS• 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.• Organized cross-functional teams for global coordination of both Research and Development programs.RESPONSIBILITIES• Organized R&D functions to cover full range of activity for concept-through-launch efforts. • Established program road-maps, design scope, release schedules and project accounting with structured integration with corporate commitments. • Ensured compliance to ISO 13485, 14971, 60601 and IEC 62304 for development and testing to support global certifications and product introductions.• Constructed Regulatory strategies for FDA 510(k) submissions for medical devices. Oversaw global product introductions through Regulatory submissions, including among others: Japan (MHLW); China (CFDA); Brazil (ANVISA) and Russian agencies. • Managed patent portfolio and functioning as technical advisor on project/program impact in regards to patent infringement. -
Sales And Marketing Director | Distributor Management, Marketing Strategy, Product Launch, VocTopcon Medical 2011 - 2012Oakland, New Jersey, UsDirecting 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.
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Global Marketing Director | Product Planning & Launch, Voc, Up/Downstream StrategyIridex 2006 - 2010Mountain View, California, UsDirected 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 differentiators.• 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.• Lead cross-functional teams on Merger and Acquisition programs to find revenue and business growth opportunities. Evaluated new and emerging technologies • Committee member for patent applications and reviews. -
Sr Marketing ManagerBacchus Vascular 2005 - 2006UsLed 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. -
Global Marketing ManagerLumenis 2002 - 2005Yokne'Am Ilit, Tsafon, IlIntroduced 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 and sales channels.• 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 -
Sr Biomedical EngineerVisx 1998 - 2002UsLeveraged 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.• Led programs from concept through manufacturing for global market introductions. The complexity of the product and products included both diagnostic and therapeutic system working independently and in conjunction with one another. -
Marketing ManagerVisx 1998 - 2002Us
Greg Halstead, Ms Skills
Medical Devices
Capital Equipment
Product Launch
Biomedical Engineering
Fda
Market Development
Product Development
Cross Functional Team Leadership
Commercialization
R&d
Hardware Diagnostics
Marketing
Design Control
Iso 13485
Start Ups
Sales
Global Marketing
Medical Imaging
Product Management
Sales Operations
Surgical Instruments
Healthcare
Surgery
Medical Device R&d
Electronics
Clinical Research
Clinical Trials
Competitive Analysis
Hospitals
Strategy
Life Sciences
Surgeons
Ophthalmology
V&v
Lifesciences
Design Of Experiments
Cardiology
Laser
Medical Diagnostics
Disposables
Greg Halstead, Ms Education Details
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Marquette UniversityBiomedical Engineering -
Marquette UniversityBiomedical Engineering
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Columbia Business SchoolMarketing Strategy
Frequently Asked Questions about Greg Halstead, Ms
What company does Greg Halstead, Ms work for?
Greg Halstead, Ms works for Emed Technologies Corporation
What is Greg Halstead, Ms's role at the current company?
Greg Halstead, Ms's current role is Medical Device Design & Development | Product Commercialization | Engineering & Operations Executive | Manufacturing Ramp | NPI | Entrepreneur.
What is Greg Halstead, Ms's email address?
Greg Halstead, Ms's email address is gh****@****ons.com
What is Greg Halstead, Ms's direct phone number?
Greg Halstead, Ms's direct phone number is +140880*****
What schools did Greg Halstead, Ms attend?
Greg Halstead, Ms attended Marquette University, Marquette University, Columbia Business School.
What skills is Greg Halstead, Ms known for?
Greg Halstead, Ms has skills like Medical Devices, Capital Equipment, Product Launch, Biomedical Engineering, Fda, Market Development, Product Development, Cross Functional Team Leadership, Commercialization, R&d, Hardware Diagnostics, Marketing.
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