To integrate medical device manufactures, providers, and related institutions to develop strategies and foster synergies that will enhance the business environment in the areas where clusters members conduct their operations. In order to accomplish the mission and objectives, the activities of the Cluster has been divided into 4 working groups: the Regulatory and Compliance team, Benchmark team, Education team and the Supply Chain team.
During 2007 the Medical Devices Cluster (MDC) went through a rebirth under the leadership of Miguel Centeno (Roche). Participation has increase significantly and more than fifteen companies, government agencies and suppliers have joined the Cluster.
Key Objectives
The MD cluster must facilitate the MD companies in PR to identify common goals, needs/concerns and requirements to make them more competitive in the short term and in the long term. Should integrate the academia, government and MD companies to have an integrated Strategic plan to help the MD cluster strengthen the people's skills and capabilities for future changing technologies.
The MD cluster must foster links and alliances with other associations, industrial groups, government agencies that will enhance our business operations in Puerto Rico. Should also enable and promote best, cost efficient and reliable/quality Supply chain in the Island on raw material and services.
Key Accomplishments by MD Cluster
Benchmark Team
A total of six Benchmark site visits completed. These are:
•Stryker – Lean Manufacturing
•Essilor – Power Energy Reduction
•Roche – Technical-Social Approach vs. Business Results
•Medtronic – 5 S program and Product Development Program
•ST. Jude Medical – CAPA system
•Steris – 5 S program
Regulatory & Compliance Team
Three major events have been held with the FDA Agency in Puerto Rico for the last two years;
•Regulatory Compliance Trends in the MD Industry
•Proper Use & Validation of Excel Spreadsheets in an FDA Regulated Environment
The Regulatory and Compliance Committee of the Medical Devices Cluster hosted its first "Medical Devices Industry and FDA Leadership Forum". The event took place at the Normandie hotel, on April 23, 2009. The activity attracted over 75 participants from 20 MD companies, FDA personnel, and other idustry suppliers and service providers. The main objective of the forum was to have in one place at the same time representatives of the medical devices industry in the island and identify areas of mutual collaboration. Miguel Centeno – General Manager of Roche and President of the Medical Devices Cluster welcomed the participants and summarized the MD Cluster various initiatives. Javier Vázquez, Esq., PRIDCO Executive Director, talked about PRIDCO's efforts towards the sector. According to Vázquez Medical Devices is the stronghest sector in the LifeSciences industry in Puerto Rico at this moment, with 13 out of 16 new PRIDCO promotions coming from the MD sector. Norma Mejía, Edwards Life Science General Manager and PRTEC's Board of Directors Presidnet, presented the industry challenges that Puerto Rico face. Nidia Acevedo, Esq., leader of the Regulatory and Compliance Team of the MD Cluster, moderated the forum. The three main areas of focus were: FDA approach to new medical devices approval and product transfers, recurring quality and regulatory compliance issues, and domestic vs. international inspection programs.
Over fifteen companies were participating in the FDA events. We have achieved excellent relationship and communication channels with the local FDA agency.
Supply Chain Team
The team is responsible for compiling information on the supply chain area. The committee has worked with PRIDCO in developing a supply chain survey, that can be access through PRIDCO's webpage. First MD Supply Chain Summit was held with over 150 people and more than 20 participating companies. Purchaisng Best practices activity was held in CooperVision to share ways to save money thru P cards, services consolidation, expenses controls, etc.
Enlace 2009 – First Encounter of Buyers and Suppliers
On June 12, 2009 the Medical Device Cluster, had their activity Enlace 2009: First Encounter of Buyers and Suppliers at the Señorial Convention Center in Ponce. The objectives was to bring together buyers from the Medical Device Industry with suppliers from different areas to exchange information, and explore business opportunities. To accomplish that goal one to one meetings were arranged in advance between Medical companies buyers and the various suppliers in attendance. The activity also included a presentation of Law 73 and its implications to supply chain by: Amaya Iraolagoitia Esq., Roxana Cruz Esq., Mr. Edgardo Arroyo and Mrs. Marilú Ortiz, and a seconf presentation: "PRIDCO's plans and strategies for the Biological Sciences Industries with focus in Medical Device's" ny Javier Vázquez, Esq., PRIDCO Executive Director. A total of 100 participants were in attendence with more than 30 suppliers and 15 MD companies represented. Initial feedback from the participants in the activity was excellent, with some suppliers obtaining positive response to the one to one exchange. Matching of MD companies needs with key suppliers were achieved as well a Government Incentives Program were shared to improve our competitiveness.
Education & Training Team
The MD Cluster in collaboration with the Polythehnic University submitted and were awarded a grant from the Department of Labor Occupational Development and Human Resources Council (CDORH). The curriculim included six areas:
•Business Writing and Presentation Skills •Computers Skills
•Quality Improvement Program •Fundamentals of Automation
•Project Management •Problem Solving Techniques