I compiled the guide below along with The diaTribe Foundation’s Ava Runge and Adam Brown based on our experiences as patients engaging in the product development world. This is an evolving document, and we would love for others to share additional “best practices” that could be included in our guide. Read on below and please email us to share your thoughts and submit your ideas!

Best Practices for Manufacturers to Engage People with Chronic Diseases

Patient-centered design is critical to a product’s success, both in benefiting patients and in contributing to a thriving marketplace. While a number of drug and device manufacturers have engaged patients in meaningful ways over the last decade, others have found it challenging to effectively engage patients throughout the product lifecycle. At The diaTribe Foundation, we believe this process can be improved through thoughtful, deliberate engagement, careful planning, and rigorous, relentless follow-up. A conscientious approach to soliciting patient feedback is needed, and given the heterogeneity of our patient population in diabetes, as well as in many other therapeutic areas, this is much easier said than done. To that end, we have drafted a list of best practices for engaging patients in early stage R&D, product development and design, and quality assessment, drawing on our own experiences both as patients and as writers about the marketplace. While we approach this list from a diabetes-centered perspective, similar strategies may also be applied to products for other diseases.  We hope this list can help manufacturers successfully use patient feedback and opinions to develop and hone their products and to have a greater opportunity for successful use and ability to help patients access innovation.

1. Ask people with diabetes to share their problems and use this information to drive product design. What do patients most need their therapies to address? What problems do they have with their current therapies and technologies? Products will have a greater chance of success, in our view, if they are built to solve a fundamental problem or address gaps. Adding novel features is also of interest but for many patients may be secondary to resolving issues that help patients manage their disease each day.
2. Be conscientious of patients’ time and finances.  When involving patients in a focus group or other market research meetings, structure the time carefully and let patients know as much as possible about your expectations – consider asking their advice even on this section of the planning! Be intentional about your questions, solicit input in a way that will be useful to your organization, and have a plan for incorporating the feedback into your R&D pipeline and in communicating to patients how this has been done or why it hasn’t. Communicating this plan to patients will be so appreciated and can help enable valuable iteration. Use the time to learn from patients; as a result, they will learn benefits of your products but ideally that would be secondary.
3. In addition, recognize that focus group participants may be taking a day off of work in order to help you and this will be easier for some than others. Most organizations automatically compensate patients for their time but we stress the importance of this because it is not always done. Strive to get a diverse group of patients (ethnic, socio-economic, linguistic, gender, etc.) Although it may not always be the case, assume that they will be giving up pay for their efforts if they are not reimbursed. It goes without saying that patients should have travel expenses covered 100%, including convenient transportation to the airport if needed, parking, healthy food throughout the day, and comfortable air travel that allows them to easily work on flights if needed (even small things like asking  for their preferences on seats and for frequent flier numbers is often very appreciated to reduce hassle at their end). Arrange pickups for them at the airports each way or make it easy for them to give you receipts for taxis/cars. In addition to paying for their time, or instead of, if you do not have the budget, consider offering a small donation for their favorite nonprofit.
4. Ask patients to share the tradeoffs they are willing to accept for a given outcome. This will help you assess your product: what is it adding to patients’ lives, and what is it asking of people? Sometimes the balance goes in the wrong direction with new products, and this can create additional burdens for patients. Of course, the balance will vary from person to person, sometimes dramatically. Work to understand “population” views by gathering broad groups and testing assumptions gleaned from focus groups in larger groups where possible.
5. Focus groups, advisory boards, and social media summits should reflect the diversity of the intended user population – depending on the group, this may be particularly important. Invite this full spectrum for feedback. Optimizing this will vary depending on the situation; in many areas, this will work best if you can engage patients through different channels (e.g., not everyone is on social media or can take time off work to fly across the country for a focus group), and choosing a wider mix than the typical “influencer” crowd.
6. Solicit patient feedback earlier and more often. Drug and device development optimally starts with patients early and is sustained well after the product has been launched. Patient feedback should inform the fundamental purpose of the product. When you invite patients to interact with scientific or medical KOLS, it will help if you express excitement to others that will be there that the patients will be joining you, and make sure the KOLs have the patient bios ahead of time and vice versa (see below). Ask for examples of the patient’s work ahead of time and ask if it would be appropriate to share it.
7. Prepare patients well. Inform them well in advance who will be there from your organization, what roles they have, and what will be discussed. Educate them beforehand so they can all start on the same page. Introductions are key – do research and introduce them properly with respect (not just reading from a page) and engage them, asking questions, listening, pausing. Figure out ahead of time how to pronounce names.
8. Arrange for patients to have some time to interact socially with leaders and with each other. Give bios ahead of time as well as contact information (ask permission of course as ask patients to use this information judiciously). 
9. Use passive data collection to increase the volume of patient input. Use artificial intelligence and other tools to mine content on social media and product reviews and use it to inform product design.
10. Watch patients use products in a real-world setting. Where appropriate, visit people in their homes, invite them to dinner, or try to stop by their work. Watch how they use their current tools to check their blood glucose, administer injections, take oral medications, and use other products or technology. Where is the pain point? Maybe they have a hard time opening the package containing the infusion set, zipping close their BGM case, or stopping their current activity to treat their hypoglycemia. Patients have learned to live with many of these challenges and may not even be aware that they are areas for improvement.
11. Make focus groups and clinical trials easy to join. Advertise opportunities for patient engagement widely through diverse channels, and offer them in locations throughout the country. Make inclusion criteria and participation information clear (crystal clear!), and offer to pay all expenses at minimum. Tell people about the opportunity well in advance – several month at minimum. 
12. Learn from consumer product manufacturers, particularly technology companies (Google, Facebook, Apple). How do these companies develop their products? The world is moving faster and faster; perfect devices are hard to create and might take way too long! Great products often develop over many generations; rarely are they that way at launch. Run small experiments, learn, change the design, and repeat. Iterate relentlessly.
13. Talk to family members. Family members of people with diabetes may notice things that patients have learned to accept: in diabetes, CGM alarms throughout the night, emotional rollercoasters after out-of-range blood sugars, irregular eating patterns, etc. Many family members are eager to offer feedback to support their loved ones, and their unique perspective on living with diabetes can be a valuable resource for improving products.
14. Look to lead users for inspiration – but not too much. What are people with diabetes already doing to solve their problems? For example, the Nightscout DIY diabetes patient community hacked into commercial CGM devices, just because they wanted to remotely monitor their children’s glucose values. This eventually helped influence other movement in the field (e.g., the FDA approved remote monitoring products and down-regulate the device’s risk category – most believe this was a positive influence!). Patient innovators can offer a window into patients’ greatest priorities in terms of product improvement. However, it is also important to keep in mind that these lead users are not representative of the total population – they may be willing to accept tradeoffs in risks, treatment burden, cost, etc., which the majority of patients are not. 
15. Show patients you are using feedback. Thank them, keep up with them regularly, host period conference calls, follow up, ask if you can help patients with anything.
16. Gather feedback about the ways in which you have interacted, respond thoughtfully, and iterate. Repeat.
17. What else!
18. We are eager to expand and refine - send feedback to [email protected], [email protected], and/or [email protected].