Hans Mische Email & Phone Number

Minneapolis, Mn, Us

London, London, Gb

International consultant with significant real-world Medical Device and Life Sciences industry experience in these areas:Business Development & Strategy Product Development - Medical Devices, In Vitro Diagnostics, PharmaPoint of Care Testing platforms and procedures - COVID-19, pathogen detectionRegulatory- Strategy, Operations, Compliance, MDR, IVDRGrowth StrategiesSupply Chain - Procurement, DigitalOperating Strategy - Cost, Quality, and Performance Improvement CybersecuritySustainabilityFood SafetyAccount ManagementAlliance ManagementSales Marketinghttps://www.paconsulting.com/industries/life-sciences

International consultant with significant real-world for Medical Device and Life Sciences industry experience in these areas:- Business Development & Strategy- Upstream Marketing- Product Development- Medical Devices- In Vitro Diagnostics IVD- Manufacturing Strategies- Regulatory; EU MDR, IVDR- Program and Project Management- Business Process Improvement- Corporate Account Management- Sales Marketing - Data Analytics, AI, - Board member of start-ups- Advisor to international business development groups- Investment & Intellectual Property Due Diligence- Active engagements with entities in US, Europe, China, India, South America, Australia

Noida, Uttar Pradesh, In

• Lead EU IVDR MDR remediation efforts of Molecular & Microbiology diagnostics portfolio - Point of Care, in vitro diagnostics, clinical laboratory systems• Established and managed cross-functional teams in 10 domestic and international locations - +300 cross functional team members across 4 business units• Lead inter-company training activities and pilot programs• Lead the development of remediation procedures, processes, and templates • Guided cross-corporate collaborations and standardization• Initiated clinical evaluation strategies and test protocols • Managed multiple international business and regulatory consulting groups and advisors

Hyderabad, Ts, In

- Business development and strategy for Medical Device and Life Science - Engineering, Product Development and Manufacturing services.- Provided collaborative business leadership to internal and client teams for engineering and manufacturing services, sales and marketing positioning, product development and business strategies. - Results include developing and expanding partnerships with top-tier must-win clients, winning and maintaining multiple $XM accounts, and identifying investments culminating in significant returns. - Facilitated development of EMS Healthcare business strategies in conjunction with top-tier consulting firm. - New Business Development, Account Development, Technology development, Capability Gap Analysis, - Merger & Acquisition, Investment identification. - Molecular diagnostics, IVD, POC diagnostics- Patient monitoring, Surgical instrumentation- Product Development, Manufacturing, Sourcing, - Diagnostic Imaging, HPLC, Laboratory Equipment- IOT, Predictive Analytics- Staff Training, Team Building.

Patented mechanical device-based technologies for the treatment of atrial fibrillation, cardiac arrhythmia and hypertension (High Blood Pressure).

Us

MechanoPlasty(tm) - Patented percutaneous mechanical device technology for Vertebral Compression Fractures with distinct fixation benefits and reduced complications compared to kyphoplasty and vertebroplasty. Additionally, the mechanical fixation technology platform has applications for multiple Fixation indications such as Spine, Long Bone, Small Bone and Trauma, as well as ENT and Sinusitis and Craniomaxillofacial(CMF).www.orthoplexus.com

Novel patented device neuromodulation technology for the treatment of systemic neurologic disorders, obesity, movement disorders(Parkinson's, epilepsy)depression, cardiac arrhythmias, pain and hypertension.Electroceuticals Mechanoceuticals Mechanoelectroceuticalswww.neuromedx.com

Identification, assessment, and management of product development opportunities - Point-of-Care (POC) testing, In Vitro Diagnostics IVD, High-Throughput Screening, DNA Sample Preparation. Manage partnerships & collaborations, channel partner development, negotiate acquisitions, licenses & distribution agreements, generate product development strategies. Responsibilities included strategic IP portfolio growth and legal affairs. Program and project management. Upstream marketing and account management.Life Science and Biotech focus - molecular analytics, laboratory automation, clinical diagnostics, pathogen detection, genomic analysis, food safety.Founding member of Minnesota Food Protection Association. CADMIM Industry board representative - Microfluidics Life Science Consortium - Industry/Academia

Catheter technology - Thrombectomy, stroke therapy, distal protection/emboli retrieval, angiography, stent delivery and ancillary devices.

Medical electronics equipment - contract design, development and manufacturing • Product development and manufacturing of OEM customer’s medical and clinical diagnostic products• Collaborated on Business Development, Sales/Marketing and benchmarking activities.• Led technical reviews, presentations and proposals for prospective customers.• Coordinated design reviews and sourcing strategies to reduce COGs/manufacturing costs by up to 80%.• Strategized and coordinated product transition activities with Manufacturing and R&D engineering groups.• Participated in due diligence, strategic planning, technical reviews, and manufacturing transition activities of a $40 million product line acquisition from a major OEM.

Urologic devices, stents, prostate BPH and cancer therapies, implants, prosthetics, surgical devices, drug delivery, RF ablation, cryotherapy, business development and acquisitions, IP portfolio development, strategies and due diligence, product manufacturing transitions, pre-clinical evaluations, clinical studies, upstream marketing

St Louis, Missouri, Us

• Directed multi-functional and multi-location product development teams in the development of magnetically controlled catheters and surgical tools.• Upstream marketing activities Identified viable new Cardiovascular and Neurosurgical applications for the company’s magnetic navigation system.• Coordinated market analysis, VOC, competitive analysis and business plan development.• Identified and recruited leading KOL physicians and researchers for domestic and international programs.• Developed presentations and proposals for key customers, corporate partners, and investors.• Organized the development of pre-clinical and clinical studies.

Marlborough, Ma, Us

• Managed cross-functional development activities of the company’s high priority coronary stent program.that generated international and domestic regulatory approvals and revenues exceeding $2 billion/year.• Relocated to Israel to coordinate international development activities with strategic partner.• Participated in market analysis and business strategy, and product requirement development.• Coordinated activities between multiple international sites, companies, and personnel.• Participated in the development and coordination of multiple clinical studies.• Hands-on engagement in the development and transfer of manufacturing processes to international facilities. • Managed multiple successful cross-functional project teams of high profile product development projects - R&D, Clinical, Regulatory, and Manufacturing• Project leadership in Vascular Closure Systems, Atherectomy Devices, Stents, biodegradeable stents, thrombectomy

Chaska, Minnesota, Us

• Managed multiple R&D and product development projects focused on novel medical devices.• Invented and developed multiple devices: Drug Delivery Devices, Thrombolysis Systems, Guidewires.• Received 510(k) approvals on three drug delivery products.• Coordinated and participated in pre-clinical studies and KOL evaluations.• Recruited and established medical and research advisory board.• Developed manufacturing processes.

Bachelor, Physics/Ee

Engineering, Electrical, Electronics And Communications Engineering