SOURCES SOUGHT
R -- FDA Business Process Improvement
- Notice Date
- 5/30/2012
- Notice Type
- Sources Sought
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-BPI-2012-0001
- Archive Date
- 6/20/2012
- Point of Contact
- Elvis R. Colbert, Phone: 3018276791
- E-Mail Address
-
elvis.colbert@fda.hhs.gov
(elvis.colbert@fda.hhs.gov)
- Small Business Set-Aside
- Competitive 8(a)
- Description
- REQUEST FOR INFORMATION BUSINESS PROCESS IMPROVEMENTS TO ENHANCE MEDICAL DEVICE SOFTWARE PRE- AND POST-MARKET REVIEW PRACTICES FOOD AND DRUG ADMINISTRATION (FDA) DESCRIPTION: This is a Request For Information (RFI) being released pursuant to the Federal Acquisition Regulations (FAR) Part 10 Market Research. This is NOT a Request For Proposal, and nothing shall be construed herein or through the RFI process to commit or obligate the government to further action as a result of the RFI. In addition, contractors responding to this RFI shall bear all risks and expenses of any resources used to provide the requested information. The information collected through the process is considered to be market research as described by FAR 2.101 and in accordance with FAR 10.002. Background and Description of Requirement: The Unites States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), is responsible for regulating firms that manufacture, repackage, re-label, and import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions. CDRH recognizes that increased uses of software in medical devices, software as medical devices and software used as a tool in producing devices (medical device software) is creating the need, for FDA to systematically reevaluate our existing pre- and post-market software review practices, to develop and implement, a plan that will enhance the way CDRH currently oversees medical device software. The goal of this effort is to use process improvement methods and tools to assess current CDRH software review practices with the goal of facilitating the development of innovative products, providing adequate patient protections, and enabling and promoting best practices for the review medical device software. To do so, CDRH needs to understand the current status and trends, including external best practices, in medical device software review practices. An external and internal assessment that highlights best practices for medical device software is required to enhance existing pre- and post-market software review practices to promote innovative technologies and provide a predictable regulatory environment that meets the needs of the medical device industry. Specifically, CDRH seeks to understand current practices used in the medical device industry; compare best practices for software with those used by similar high risk industries; and understand the current strengths and weakness of FDA's programs (business processes) related to reasonably assuring safety and effectiveness of software used for healthcare. 1. Objective The objective of this contract is an assessment of current software best practices for medical device software. Medical device software is defined as software used in devices, software used as devices, and software used as a tool in the production of medical device. Assessment of software practices includes assessment of engineering, quality control and quality assurance practices used in the planning, design, development, deployment, maintenance of medical device software. Specifically, we are interested in the exploring the following primary objectives: 1. Perform an External Evaluation of Current Software Practices in the Medical Device Industry as compared to other parallel industries and academia. * Assessment of current software practices, including strengths, challenges, and opportunities applicable to the medical device industry. * Evaluation and identification of medical device industry best software practices for medical devices. * Assessment of current software practices for other parallel industries that use or make high risk and complex software products (e.g. aviation, finance, and nuclear), including but not limited to practices used to independently assure safety of software. *Evaluation and identification of other parallel industries (e.g. aviation, finance, and nuclear) best software practices used in high risk and complex software products, including but not limited to practices used to independently assure safety of software. *Evaluation and identification of emerging software practices from academia. 2. Perform an Internal Evaluation of CDRH's Current Medical Device Software Regulatory Practices. *Assessment of current software review practices, including strengths, challenges, and opportunities, to include assessment of "people" (e.g. bench strength, skill sets, and organizational structure), "processes", and information technology infrastructure. *Evaluation, identification and drill down on current review processes, significant challenges, including root cause analysis of roadblocks and inefficiencies. (e.g. include perspectives from CDRH staff that include Office of Compliance (OC), Office of Communication, Education, and Radiation Programs (OCER), Office of Device Evaluation (ODE), Office of Surveillance and Biometrics (OSB), Office of In Vitro Diagnostic Device *Evaluation and Safety (OIVD), Office of the Center Director (OCD), Office of Science and Engineering Laboratories (OSEL), and field inspection staff at Office of Regulatory Affairs (ORA). *Evaluation and identification of improvement opportunities that will help assure the safety and effectiveness of software used in devices, software used as devices, and software used as a tool in producing devices 3. Perform an in-depth current state analysis of the external and internal evaluations of medical device software review practices to determine best-practices and develop a set of recommendations for existing pre- and post-market software review practices that will improve the way the Center currently reviews software. * Analysis of gaps, process roadblocks, inefficiencies and opportunities in medical device software practices between medical device industry, academia and other parallel industries. * Identify and recommend improvements that lead to desirable state of medical device software processes that includes enabling an environment for medical device software that focuses on patient safety while promoting innovative medical device technology. * Analysis of gaps that indentifies improvement opportunities for CDRH in the areas that include "people" (e.g. bench strength, skill sets, and organizational structure), process, and information technology infrastructure that will enable effective oversight of medical device software. Respondents to this RFI shall provide the following information: a) Firm's capability statement: Contractor background summary including, contractor name, DUNS, point of contact information, email, phone and 8(a) certification documentation, and any GSA and/or NASA schedule number, if applicable. b) Past Performance- Provide a list of previous contracts where Employee Assistance Programs and other related support services were provided. Provide customer/Government Agency contact information where these services were provided including: contact name and organization, telephone number, and email address. c) Facility clearance information d) Any certifications for providing conference support as listed above. RFI Response Guidelines and Procedures: Responses to the information requested are limited to five (5) pages, not including cover and table of contents. All responses shall be submitted to Elvis R. Colbert, via email at Elvis.Colbert@fda.hhs.gov no later than 12:00pm on Tuesday June 5, 2012. No capability statements will be considered after this date and time. Please note that no telephone calls will be accepted. * PLEASE BE INFORMED THAT THIS IS AN 8(a) REQUIREMENT UNDER NAICS CODE 541611(ADMINISTRATIVE MANAGEMENT AND GENERAL MANAGEMENT CONSULTING SERVICES). ** Any contractor that responds to this RFI that has not provided 8(a) certification information will not be considered.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-BPI-2012-0001/listing.html)
- Place of Performance
- Address: WO66 RM5456, 10903 New Hampshire, silver spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02761551-W 20120601/120531000047-ae95a19696943fb4f5ccc413b74cbea1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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