Request for Information - Hearing Aid

Department of Veterans Affairs National Acquisition Center Commodities and Services Acquisition Service 555 Corporate Circle Golden, CO 80401 The Department of Veteran Affairs, National Acquisition Office (NAC), Commodities, Services, and Acquisition Services (CSAS) in conjunction with Veteran Health Administration (VHA), Prosthetic Sensory Aid Services (PSAS), is issuing a Request for Information and Sources Sought Announcement for the GSA Best in Class program Hearing Aids. The sole purpose of this announcement is for market research purposes and does not constitute a Request for Quote (RFQ)/Invitation for Bid (IFB)/Request for Proposal (RFP). This notice does not commit the U.S. Government to contract for any supply or service. Furthermore, the U.S. Government is not seeking quotes, bids or proposals at this time and will not accept unsolicited proposals in response to this notice. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Submittals will not be returned to the responder. A central tenet of acquisition reform is to significantly improve the quality of market research by conducting a market and industry survey. One of the main benefits of solid market research is to materially improve the government s understanding of the current state of the marketplace, including commercial/government best practices, industry capabilities, innovative delivery approaches, commercial market service levels, and performance strategies and measures. NAICS: 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing PSC: 6515. For upcoming recompete for Department of Veteran Affairs, GSA Best In Class, Hearing Aid program, a special emphasis of the market research is being placed on market/industry infrastructure, practices and product availability. We are interested how the market is addressing the United States Made in America, Buy American Act and Trade Agreement Acts, and how they have impacted resources and or market share. We are also interested in identifying performance criteria that differentiate between and among high-quality firms in this field. We believe this information will dramatically improve the quality of the forthcoming acquisition, including the solicitation and resulting contract. I do want to emphasize that this RFI and any subsequent requests are solely for market research and are not competitions. The information obtained from the sessions will be used to improve the government s knowledge of private industry s capabilities. No evaluation of participating parties will occur and your participation in these RFI s is not a promise of future business with Department of Veteran Affairs. No contract will be awarded from these requests. We ask that industry and or interested parties respond to Attachment 1 -Question for Industry. Electronic/emailed responses are due no later than April 24, 2023. Responding parties should take additional precautionary measures to prevent proprietary information from disclosure by marking the documentation being submitted with labeling sensitivities such as confidential and proprietary. Information provided in response to this RFI and future RFI s that is marked as proprietary will be handled accordingly. Please submit the information to contact@example.gov, contact@example.gov and contact@example.gov. A joint meeting with representatives from the Department of Veteran Affairs and industry is tentatively being schedule in June 2023 at the Denver Logistic Center located in Golden, Colorado. A separate announcement and industry day invitation will be sent to interested parties. If you are an interested parties please RSVP with contact@example.gov and contact@example.gov and contact@example.gov. Final Arrangements for industry meetings with the Department of Veteran Affairs will be announced through an Industry Day announcement posted to Contract Opportunities as well as invitations sent to those who have RSVP. Attachment 1 - Questions for the Hearing Aid Industry Responding parties should take additional precautionary measures to prevent proprietary information from disclosure by marking the documentation being submitted with labeling sensitivities such as confidential and proprietary. Information provided in response to this Request for Information (RFI) and future RFIs that is marked as proprietary will be handled accordingly. 1. Please explain your company s position in the marketplace? Please explain your parent subsidiary relationship with respect to the Hearing Aid Industry. Do you subcontract? If so, explain the nature of these subcontracts? To what extent are you currently subcontracting with small business and at what percentages? In the Hearing Aid Industry, are you considered a Contract Manufacturer, Manufacturer, Distributor, Foreign Exporter, or Repackager/ Relabeler? How many individuals do you currently employ? What is your Socio-Economic Indicator if defined as a Small Business? Are your registered and certified through Small Business Administration as a Women-Owned Small Business, 8(a) Small Business, Service-Disabled Veteran-Owned Small Business, Veteran-Owned Small Business or Historically Underutilized Business Zone Business? Of the sellers, what is your market share? Do you see the industry shrinking or growing? Is the number of buyers and suppliers scarce or plentiful? What is the downstream effect? What do you see the other buyers doing in their buying practices? Does your supply exceed demand or vice versa? What influences does the United States Federal Government as a buyer have on supply and demand? What are the current economic trends that have an impact on the products and/or services, including the use of raw materials or major components? What is the future projection of the sources of raw materials to support sustainment of production by your company? How do the federal governments sustainability requirements impact products and/or services? Are there insolvency issues among sellers and suppliers? Is there litigation pending that affects the broad market or key sellers? Is the industry regulated? If so at what levels? 2. What are the significant components of the products and or services? Has your company identified warning signs that disruptions can occur in the supply of raw materials? From where do you source your supplies for the manufacture of the hearing aid products? from where do you source the raw materials or components?What companies provide the raw materials and/or major components, and what is the market share for each company? How many suppliers exist in the raw material or component supply chain? Are there any United States suppliers? What risks are inherent to the supply of raw materials? Is there any supply chain constraints VA needs to be aware of including any environmental as well infrastructure constraints? How has your company changed, if at all, it s manufacturing processes to address the current administration s priority of U.S. made products? Can your supply chain support a large-scale implementation (i.e., greater than 8,000,000 concurrent patient users nationwide)? 3. What is the company s philosophy and technology focus? What is the next iteration of product lines and services? Where do you see the industry in the next 5 to 10 years? How quickly is this industry changing? Explain the science and philosophy behind your proprietary fitting algorithms. How are they derived? What does the company spend annually on product R&D? Are those costs reduced because of exclusive access to information developed from specific research institutions? 4. With the emerging technology changes, please explain the following future of: How do you envision the use of AI/machine learning in future product design, fitting and function? Connectivity of wireless technologies? Interactions with other devices? Battery options and future changes, including any charging options. Programming advancements? (i.e., Self- Fitting) Other features being considered? (i.e., Steps, Heart Rate) Remote programming capability? Considerations for ear scanning? What is being done to improve microphone resistance to the effects of moisture? 5. What is your FDA registration status for 2023? What is your FDA Registration Number? What is your FDA Product Code? 6. What are your current product lines? What are the Hearing Aid Earmold options? Are the products battery-operated, rechargeable, or a hybrid option? If rechargeable, what ancillary items should be considered? Can the hearing aid be recycled? What is the fitting range? What are the Signal Processing Strategies? Describe the Wireless/Bluetooth Connectivity: 1. Is it between hearing aids? 2. Is it between hearing aids and wireless accessories? 3. Is it between hearing aids and other technology? 4. What is the Bluetooth Low Energy capability for the product? 5. Connectivity of wireless technologies? 6. Interactions with other devices? 7. Remote programming capability? 8. Is there a Telecoil component to the device? 9. What is the universal programming compatibility? 10. Are there any smart phone applications or web applications? 11. What is the lifespan of the device? 12. What is the country of origin of the device? 13. What is the manufacturing facilities ISO certification and standard? 14. Can your product be branded or white labeled? 15. What options can you provide for dual sensory impaired patients? (Example: High Contrast Casing, Tactile Assistance) i. Is this something you have already done for other health care customers? If so, how? 7. What is the company s commercial practices? Explain and identify what is a priced component and a no cost component.What is provided as a package with the hearing aid (i.e., what is included)? What are your commercial standard delivery time frames? What are your current shipping rates? What is the expected future shipping rate? What is the commercial standard practice for trial periods? What is the commercial standard warranty for the products? What is the commercial standard for loss and damage? What is the definition of damage beyond repair? 8. What type of education do you offer to VA clinical staff? What customer service do you provide for clinical staff and patients? What are the methods of contact? What are the hours of operation? What types of programming for device support is offered? i. Are there remote programming opportunities? 10. Please explain the IT data technical components associated with your products. Who controls the device? What type of data is collected or accessed? i. Does this data include health information? ii. Is the health information de-identified under HIPAA Privacy Rule of Safe Harbor or Expert? iii. Does the device collect and store data? How does your solution transmit data and what kind of connectedness is required? i. Is the data that is transmitted HIPAA-compliant? Is the data or information collected or accessed have Personally Identifiable Information (PII) on patients? i. What type of PII is included (Social Security Number, Address or other)? Do you consider the data collected to be your company s intellectual property? i. What aspects of the technology considered intellectual property? Is there an associated app for your devices? Do all of your devices include an app? 11. Can your company provide manuals and other materials in accordance with the Rehabilitation Act Amendments of 1998, Section 508 compliance? 12. If you are a current awardee for the Veteran Affairs Hearing Aid contract, are there any recommendations for changes within the contract? Please explain reasoning for the change. Are there any reporting requirements you would like to see in the new contracts? Is the language of the contract in any way exclusionary to other technology available in your commercial portfolios today, or in any way inhibitory to anticipated technological advancements in the near future? Is doing business under the provisions of the current contract burdensome in ways that you view to be unnecessary or counterproductive? Is there potential to reduce costs to the federal government if such unnecessary or counterproductive requirements are revised or eliminated? 13. Vendors will be required to utilize ANSI X.12 EDI (Electronic Data Interchange) transaction sets for exchange of purchase orders/amendments and invoices with VA. Please describe your existing or planned capabilities for use of the X.12 EDI standard. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Submittals will not be returned to the responder.