D EFINING T HE F UZZY F RONT E ND Connie L. Luthy Product Architect Medical Product Innovation

1. DEFININGTHEFUZZY FRONT END Connie L. Luthy Product Architect Medical Product Innovation Medical Product Innovation

2. What does a Strategist do? Asks questions Today’s Format: Ask questions Examples from my experience Medical Product Innovation

3. MPI Scope:Industry Clusters Medical Devices Drugs Diagnostics Suppliers to those industries Medical Product Innovation

4. MPIProduct Experience Indicationsanti-proliferation, anti-tumor, bone marrow ablation, wound healing, anti-infection, anti-inflammatory, systemic fungal infection, minimizing surgical trauma, IOP control, contact lens disinfection Therapeutic Agentsanti-neoplastic, radionuclides, platinum, anti-glaucoma (anti-hypertensive), anti-infective, anti-inflammatory, hormones, anti-oxidant, glutathione precursors, angiostatic steroids, growth factors Medical Devicesviscoelastic agents, collagen corneal shield, corneal storage media, absorbable sutures, implants, surgical instruments Diagnostic Agentsfluoroimmunoassays, imaging contrast agents, radiodiagnostic agents Medical Product Innovation

5. MPIProduct Experience Cont’d Dosage Formstopical--sterile preserved solution, suspension, ointment, gel, fiber, liposomeinjectible-- wet/wet two-part, wet/dry two-part, solution, liposome, microparticleimplantable--devices, gels, suturesdiagnostic--microspheres, surface modified liposomes Biomaterialshyaluronate, chondroitin, heparin, dermatan, collagen, modified collagens, alginate, fibrin clotting system, lysozyme, lactoferrin, enzymatic hypoiodite-generating system, enzymatic peroxide-generating system, monoclonal antibodies, phospholipids, lecithin, biotin, avidin, peptide tethers Synthetic Polymershigh MW polyamines, HPMC, PVA, modified hydrogels, carbopol films, modified PMMA, cyanoacrylates, modified nylons Research Productsgenome chip Medical Product Innovation

6. Invention IS NOT Innovation! “Innovation has occurred when a useful new-to-the-world product or process is available to the customer. Innovation is the result of a successful new product development process.” Medical Product Innovation

7. MPI’s Three Keys to Entrepreneurial Success Management Team Management Team Management Team “Get the people; get the money.” Guy KawasakiCEO, Garage Technology VenturesRules for Revolutionaries Medical Product Innovation

8. Business Scope Are you developing: A Product A Technology or discovering the Laws of Nature? Medical Product Innovation

9. Conclusion:Don’t Try This at Home! • Product Development IS NOT taught in school. • The only place it is effectively and efficiently taught is inside PROFITABLE companies in the SAME industry. • If you are not able to attract employees with appropriate experience, OUTSOURCE! Medical Product Innovation

10. Product Strategy Registration Strategy Management Team Complete Picture for MPD $ Well-designed products get funded, developed, approved and change lives! Medical Product Innovation

11. Please Visit Product Development & Management Association http://www.pdma.org Medical Product Innovation