SBRI Healthcare: NHS England competition for Phase 2 contracts These Guidance Notes are designed to help you complete your application. Phase 2 is intended to expand on the technical feasibility testing of Phase 1, funding a further 12 months of development work to substantially progress projects towards commercialisation. A total contract amount of 1 million (incl. VAT) is available to cover costs associated with product development, market research, user testing, workshops and clinical validation, although as each project is individual there are no absolute requirements for the types of activities that we expect a Phase 2 application to include. However, it is important to keep in mind the time lines, especially for pieces of work involving clinical testing and validation, and be certain to make sure each work package has appropriate milestones/end points for the end of Phase 2 to demonstrate the project s progress. Please note that only one Phase 2 application can be submitted to apply f or further support for an awarded Phase 1 project. Phase 2 applications need to continue to meet the same needs as described in the competition brief under which your project s was awarded a Phase 1 contract. Application Process All applications will be treated in confidence. The application process for the SBRI Healthcare competition is managed via the SBRI Healthcare portal, which is available from the SBRI Healthcare website at www.sbrihealthcare.co.uk by clicking on the Log In link located at the top of the page, or by going directly to: https://colab-sbri.fluidreview.com/. Phase 2 application forms are presented in the portal as a specific group of tasks available from the same folder as a company s successful Phase 1 application, and become available to applicants at the beginning of the second quarter of Phase 1 projects. Completed applications should be submitted electronically through the SBRI Healthcare portal. Failure to use the application form and follow this Guidance could result in the removal of an application from the assessment process. Using the portal 1. Click on the Log In link on the SBRI Healthcare website You will need to use the SBRI Healthcare portal login that was set up for the Phase 1 application, please contact sbrienquiries@hee.co.uk, or ring 01223 928 040 if you require a password reminder. 2. Go to the Submissions page in your account and select the project that has been awarded Phase 1 funding, and that is now eligible to progress to a Phase 2 contract. Once the Phase 2 application forms have been released by the SBRI Healthcare team, they will appear as a set of seven tasks under the SBRI Phase 2 heading. Please note that completion of all tasks is required before applicants can submit their application via the Phase 2 Declaration task.
Starting an application Individual tasks will be shown as complete on the task index page once all mandatory questions have been answered. Questions where answers are outstanding are indicated to applicants when either the Save Progress or Check Form buttons, located at the bottom of a task s page, is pressed. Revisiting an unsubmitted application Applicants can save an incomplete task to revisit and complete at a later time by clicking on the Save Progress button and using the links at the top of the page to navigate away, or close down the browser. Entered content will be saved even if mandatory questions have not been answered. If an applicant revisits a multi-page task, such as the Phase 2 Application form, then an applicant will be taken to the last visited page. 3. Phase 2 Additional Material Task This task enables applicants to upload a file to supports their Phase 2 application. Inclusion of a Gantt chart in this file is highly recommended, and remaining space can be used to include graphs, photographs, graphics, external references. Please note however that this single attachment must be limited to the equivalent of 4 A4 pages. Attachments exceeding this limit will not be considered by the SBRI Healthcare panel. Upon uploading of an attachment, the portal will open and display the contents of the file, to allow applicants to verify that it has been successfully uploaded. Please note however that this viewer will display documents at a relatively low resolution; Phase 2 assessors are encouraged to download submitted images to ensure they are viewed correctly. Once an attachment is uploaded, it can be replaced by uploading a new file. Note that only one file can be uploaded using this task. 4. Phase 2 Finance Sheet Task The SBRI Healthcare team will provide all projects with a template Excel workbook that provides a framework for submitting a Phase 2 project budget. Please do not edit the format of this workbook and upload it to the portal as an.xslx file. 5. Invite other team members to help with your application The portal allows multiple people to complete tasks within your workspace at the same time. You can give other people access to your workspace by using the Add Member link, available from the Submission Tasks index page. Team members can be given different access levels to the application. 6. Ensure you have completed all tasks before trying to submit your application You can check the tasks you still have to complete by looking on the Submission Tasks index page 7. Submit your application The deadline for your Phase 2 applications will be 14 working days after the end date of the Phase 1 contract. SBRI Healthcare Phase2 Guidance 2
Only the owner of an application is able to submit it to the competition via the portal. The owner of the application will receive an email confirming their application has been successfully submitted. Please note that Final Phase 1 Progress Reports and Finance spreadsheets need to be submitted to the portal at the same time as the Phase 2 application, as all documents will be required by the interviewing panel. Guidance for completing your application Guidance on the individual sections of the application form is provided in the following sections: Phase 2 Application Summary Proposal Title (max word limit: 10) Please provide a short, descriptive title for the project that would be suitable for publication Project duration Phase 2 projects are a maximum of 12 months duration. Total Contract Cost ( s) Proposed projects can request a maximum total cost of 1,000,000 inclusive of VAT. Abstract for publication Please provide a brief, public facing description of the project. Should your project be successful, this information will be made public (via press releases and other marketing activities) once the award is confirmed. We reserve the right to amend the description before publication if necessary, but will consult you about any changes. Contact Details Please provide the lead applicant s name and contact details. This will be the information used by SBRI Healthcare to contact you regarding this application. Lead applicants are expected, before submitting applications, to have discussed their proposals with their own company or any other body whose co-operation will be required in the conduct of the project. By submitting the application the lead applicant must confirming that the information given in this application is complete and that they will be actively engaged in this project and responsible for its overall management and agree to administer the award if made. Phase 2 Company Details Please provide updated information on the lead organisation in these fields. Phase 2 Application Form The Phase 2 Application Form task is split over 4 pages. When completing this task, to progress to the next page using the Check Form & Next Page button, the portal will require each mandatory field to be appropriately answered. Applicants can however, navigate to later pages by using the Page 1, Page 2, Page 3 and Page 4 links available at the top of each page. Outcomes from your SBRI Healthcare Phase 1 project (maximum 900 words) SBRI Healthcare Phase2 Guidance 3
Please provide a summary of the outcomes from your Phase 1 project, and how they support and manage any risk relating to the development work for Phase 2. Please include details of steps you have taken to verify the demand and need for your solution with clinicians, potential end -users and commissioners (as appropriate). While assessors will have the project s Phase 1 Final report available to them, it is advised that applicants should included in this section an explanation in layman s terms the key factors of the project, what was accomplished in Phase 1, how this was achieved, how you have engaged clinical and end-user partners, and why Phase 2 is now relevant. Summary of expected outcomes from Phase 2 (maximum 700 words) Clearly describe the new product or service that would be available at the end of Phase 2. Please also specify the milestone or outcome that would mark the end of Phase 2. Technical Summary (maximum 900 words) Please describe: Technical background from Phase 1 Key deliverables for Phase 2 Technical challenges for Phase 2 Plans to address technical challenges for Phase 2 Technical detail of the project should be provided here. Describe the work completed in Phase 1 and the work to be done in Phase 2, with deliverables broken down into stages and key milestones. Indicate how the project will overcome the challenges of development. Current State of the Art and Intellectual Property (maximum 900 words) Since Phase 1 the landscape may have changed. You may have developed new IP and others may have filed their own. Please describe here all relevant competing IP, and related products, that may influence the success of your project. Clearly detail the ownership of background IP, any relationships that must be upheld to secure future access and why, with this IP, your product is better than the competition. Cost effectiveness is an important factor to consider in regards to comparisons with the competition. Describe any other existing third party Intellectual Property (IP) not owned exclusively by the applicant, and its significance to your freedom to operate. Describe the proposed advance on the current state of the art. Explain why this product will be more effective than other products currently on the market. In case there are no comparable products, what would be the advantage over the current standard of clinical care? Specify any background IP on which your project relies and confirm that you have secured access to this IP for both the completion of the project and its commercial use in the UK. Do not forget to include all relevant patent application and/or granted patent numbers. Project Plan and Deliverables (maximum 1350 words) Please provide a detailed description of the proposed Phase 2 project, supplemented by the table below. This section should identify milestones and timings. If you wish to do so, applicants can add a separate file for the Gantt chart (using the instructions for attaching documents in the guidance above). A maximum of 20 milestones can be used to describe SBRI Healthcare Phase2 Guidance 4
Clearly state how you would define success at each significant milestone in the project. Note that the milestones stated may be used as part of the contract if your application is successful. Please highlight any expected changes for Phase 2 from the project team that delivered Phase 1. Also identify the project manager, if different from the lead applicant. Please provide details of planned subcontracting agreements, and confirm if those agreements are already in place. Detail is important here. Explain with precision what it is that will be done in Phase 2, by whom and by when. Concise definitions of success for each milestone are also essential and these should be tangible deliverables. The whole plan should allow reviewers to easily understand what will be achieved and how you will know it has been successful. A mention of the milestone and/or deliverable that marks the end of Phase 2 is essential here. The table should serve as a summary of this information by highlighting the key milestones, the timelines and responsibility for their delivery and the tangible outcome which will signify successful completion of the milestone. A maximum of 20 milestones can be defined for the Phase 2 project. it Is advised that milestone dates should be aligned with the programme s quarterly interim reporting requirements, to assist in the description of the project s progress. Commercial and Health Economic Aspects of the Product (maximum 1350 words) Please describe how the product will be commercialised and the planned route to market (distribution, sales, etc.). Please include: A prediction of the target pricing and margins anticipated for this product A discussion the health economic benefits that this product could deliver for the NHS A brief review of the market size for this product in the NHS and beyond (EU, US, etc.), including growth rate of the market, main competitors and potential adoption issues A description of your plans for full commercial implementation including plans for internationalisation. An indication of whether additional funding will be required to commercialise the product. If so, describe the expected capital investment and the plans to raise this. Information gained from Phase 1 Health Economic reports may help here. Please show evidence of your understanding of the current market, entry points, and how you will position yourself within it to have widespread adoption (UK and otherwise). Are you more cost effective/efficacious and therefore more attractive, than the competition? Why will your solution be adopted and who will be paying? Plans for manufacturing (if applicable) (maximum 900 words) Outline the plan for manufacturing the product. If applicable, describe the current scale of manufacture and how easy it is to scale up the manufacturing process. Describe any issues that need to be resolved in order to have a reliable manufacturing process. Indicate whether the product will be manufactured in-house or will involve third party manufacturing. If this is the case, have third party manufacturers been identified? Please describe the quality systems and regulatory requirements which apply to the manufacture of the product. SBRI Healthcare Phase2 Guidance 5
Declaration Provide an anticipated cost of the final product Enter N/A in this field, if such information is not applicable to the project, however we expect that most projects funded will need to answer at least some of the aspects listed above. SBRI Healthcare accepts that third parties may be involved in manufacture, however include details on why an organisation was chosen and the agreements in place to secure their collaboration. Information on how teams will be able to work to scale and meet regulatory requirements is also important to include. Finances (maximum 900 words) Please provide the following: a summary of the costs for the contractor and any subcontractors a justification of the costs of each work package of Phase 2 a list of your project s Phase 2 staged milestones and the costs for delivering each one a proposed payment schedule for each quarter of Phase 2 Note: A separate financial spreadsheet template is provided to describe Phase 2 costs in detail. It is suggested that you complete the financial template offline before uploading to the portal (following the instructions on attaching documents above) and then use the space in this section to provide free text commentary to the spreadsheet. Development team for Phase 2 (maximum 900 words) Please provide a description of your project team, describing the expertise of each member relevant to this application, their role during Phase 2 and the proportion of their time they will be spending on the project. Additional information about the lead company (maximum 450 words) Please provide a brief summary of the key strategic objectives of your company over the next five years time, and whether there has been any change to the ownership status of the party that had a controlling interest in your company when it entered into the contract governing Phase 1. This is especially important if you have set up a new company during Phase 1. Details on future funding requirements, plans for expansion and ownership are particularly important to see here. In order for your application to be accepted you are required to gain approval from the relevant authorities within your company. These approvals are required to ensure that the costs submitted are agreed by the company as an accurate detailed estimate of the cost of undertaking the proposed project. Please complete the Declaration task on the Tasks tab. Lead applicants are expected, before submitting applications, to have discussed their proposals with their own company or any other body whose co-operation will be required in the conduct of the project. By completing the declaration you are confirming that the information given in this application is complete and that you are actively engaged in this project and responsible for its overall management and agree to administe r the award, if successful. For more information on the SBRI Healthcare programme please see www.sbrihealthcare.co.uk. Questions on the challenges and scope of this SBRI Healthcare competition should be addressed to Health Enterprise East via email to sbrienquiries@hee.co.uk. SBRI Healthcare Phase2 Guidance 6