Case Studies: research & development
Co-Creation: Patient Initiated Product Development
Claudia and Ilona Brandt are twin sisters. They are SMA (spinal muscular atrophy) patients and founders of the SMArty-Symposium in Germany. Through their disease, they regularly observe unmet needs and optimization potentials for their medical aids and other treatment and care related technologies. Their continuous experiments and discussions about improvements started as early as the age of around twelve years. At that time, Ilona and Claudia Brandt tried to solve their daily problems through simple actions, like e.g. moving their wheelchair in a sloping position on the boardwalk to shift emphasis and reduce pressure and pain.
They started to think about a high sensitivity control platform for the seat regardless the wheelchair model. This led to first sketches and outlines and numerous contacts with wheelchair manufacturers. However, finding a partner was quite difficult. Finally, they started to co-develop with one of their former civilian service helper at their school, who now owns a company for standing systems and mobility solutions. In close cooperation they overcame all challenges and co-created a seat-tilting platform which can be adapted to any wheelchair. The product was introduced to the markets at REHACARE, Düsseldorf, in September 2018 and is now available to patients!
If you are interested to see COSEAT®in full action, please click here.
Gravity is one of the major problems for people with less muscle power or paralysis and causes several issues, which should be taken into account during the development of a wheelchair. This means, when using a wheelchair, the inability of movement of its user needs to be addressed to avoid discomforts and medical risks, like
- Pressure points on the body and higher risk for decubitus resulted by limited or even non-existing movements
- Impaired respiration and pinched nerves caused by unnatural sitting positions due to continuous slumping down of the body
- Circulatory problems due to missing micro positioning of the body
- Body shifting through unevenness, e.g. hands can be removed from control panels like emergency stop
- General discomforts like unpractical sitting position during serving of meals and drinks
Obviously, Claudia and Ilona Brandt have known these issues and risks since many years. They used to face them by simple actions like positioning the wheelchair on an uphill or moving the wheelchair in a sloping position on the boardwalk to shift emphasis and reduce pressure and pain. Besides the significant risk to roll over, these actions are limited to the surrounding environment and thus not possible in buildings or during transportation, e.g. in busses or trains. Resulting pain and respiratory issues are very stressful and strongly constrain quality of life.
The search of the right development partner, who was willing to really listen, understand their needs and ideas for resolution, and recognizing the potential for many more users was the biggest challenge for the twin sisters Brandt. Besides high interest, technical expertise and motivation the partner was required to allocate sufficient resources in regards of investment and man-power over a complex, time-consuming and expensive development process. Such a partner is difficult to find. Thus, what a herculean-task for industry outsiders, even more so for people with severe disabilities like Ilona and Claudia!
Also, during the development process further challenges appeared. It turned out to be highly challenging to achieve all objectives without an unacceptable increase of cost and the size of the wheelchair. The final wheelchair still had to be price-competitive in a highly competitive environment. Furthermore, increasing regulatory requirements had to be adhered to and added to time, resources and cost planned.
Another main challenge was communication about the development progress and the need for adaptations. Since their mobility is limited, physical meetings and usability tests with Ilona and Claudia were rare and difficult to organize. Communication by phone and video calls helped but matching calendar slots of a full-time working SMA patient with a medical aids company’s day is challenging. Slots had to be found during the sisters’ free time out of work less the time needed for care and assistance. Setting the priorities right for the most efficient subjects for co-creation was complex though.
The focus was the development of a wheelchair with electronically adjustable joints to relief the body through shift of emphasis and automatic swiveling.
Further features should help to solve medical issues and fulfill preferences for the maximum benefit of the wheelchair user. Besides a continuous electronic seat tilting in all directions, settings needed to be controllable by the users themselves, even with limited residual muscle functions.
Over the years Claudia and Iona Brandt observed many launches of innovative wheelchairs, but none of them met all their medical needs. Back in 2010 Claudia and Ilona Brandt decided to become active and contacted several wheelchair manufacturers to discuss an experimental pilot project. Finally, they found great enthusiasm with a friend, who had been one of their care assistants during his civil service many years ago. Today he has his own company for standing systems and mobility solutions like wheelchairs. They shared the vision of creating highly innovative technology many immobilized patients can significantly benefit from.
The company committed the required time and money to realize the co-creation project. The company owner took an active part in the project himself. The twin sisters’ idea needed to be designed from the scratch. Different approaches for smooth, continuous and non-abrupt-stopping motions were thought through and tested until the final solution of a 4-motor mechatronic was found. Different specialists communicated directly and frequently with especially Claudia Brandt. For the field tests starting in 2014 Claudia needed her own wheelchair to be combined with the novel seating platform. This required a complex application process for cost coverage with her German health insurance who finally agreed. Claudia and Ilona Brandt were integrated in numerous meetings, feedback loops and interim tests during development. They visited the production and got to know all project members face-to-face. Every exchange with the sisters led to important conclusions regarding confirmation or necessary changes and adaptations to the product features. In 2017 Claudia Brandt received the first marketed COSEAT®on her new wheelchair. During the field test in 2017, several smaller and bigger issues were discovered and solved successfully.
The final technology COSEAT®was presented at the REHACARE, Düsseldorf, in September 2018 and is now available to patients, please click here!
What went well
After the initial contact through Claudia and Ilona Brandt, the company demonstrated high motivation, stamina and integrated the twin sisters in a most appropriate way. The company did not only take the chance of a patient-initiated innovative development, they also ensured a successful integration of the patient view during the entire project. The team showed an extraordinary appreciation for the value of the patient/user perspective. The numerous exchanges resulted in significant changes, improvements and -where necessary- mutually acceptable compromises in the interest of users, which would have hardly been identified without the direct involvement of the sisters.
What can be improved?
The coordination of timelines and expectations demand an extra effort in collaborations like this one.
Based on the experience with a technology failure during one of the field tests a 24/7 emergency concept should be standard to avoid any complications.
Considerations and recommendations
This success story impressively demonstrates the potential of patient driven innovation and co-creation for the industry. It also is an example for how co-creation with patients in product development can lead to a much better product. Globally there are lots of good examples for patients or their relatives and caregivers coming up with solutions for their own issues. They need companies with a vision to help turning these ideas into products.
Examples for highly innovative patient entrepreneurs can be found at e.g. Lyfebulb’s Innovation Challenge, the cure mission of French AFM-Telethon or glancing through the stories of organisations like the Swiss Foundation Marisa Sophie or US based Amicus Therapeutics.
In the end it was due to Ilona and Claudia who relentlessly worked on finding the right partner to start product development happen which now can help many patients. However, the limitations for patients with innovative ideas for how to resolve issues are obvious and it should not be only with them to look for partners.
Companies who know the patient community of a certain therapeutic field of interest well and interact early with its major protagonists, will have a chance to identify those innovative minds and ideas and can actively help to make things happen.
Therefore, companies which are willing to develop innovative products in collaboration with patients should actively communicate this and establish appropriate search and collaboration processes accordingly.
Help us improve this guidebook
Considerations for Implementing Expert Patient/Patient Group Input
Recommended Contributors :
- Program leaders
- Patient liaisons
- Sponsor representatives
- Clinical investigators
- Research team
- Trial site staff
- Expert patient(s)/Patient Group representatives
Communicating with Patients throughout the Program
- How does the phase of drug/biologic/device development process covered by this program impact communication with patients?
- What translation and/or cultural adaptions?
- Wat language will be used to communicate with and about the patients?
- Are research questions and procedures culturally sensitive and appropriate?
- How will patients be referred to (e.g. “subject” vs. “patient” vs. “participant”)?
- What is the communication plan for patients throughout the program?
- Message content
- Delivery mechanisms
- Feedback mechanisms
- What feedback mechanisms and processes are in place for the patients to comment on sites, investigators, and the study participant experience?
- What role will social media play in the communications?
- How is social media defined?
- What restrictions should there be, if any?
- How can social media be used to advantage (e.g. for trial recruitment, to educate patients)?
- What limits should be placed on use of social media, if any? Why?
- How will those limits be communicated and enforced?
- What methods will be used to interact with patients and other stakeholders?
- Focus groups
- Inclusion on advisory councils
- Inclusion in meetings with researchers
- What data/information can and will be shared with the patients and when?
- Aggregate (de-identified)
- What are the restrictions (propieratry and regulatory) constraining the release of data?
- How do we ensure that this information is shared in patient-friendly language? How will that be determined/monitored?
Communication Handbook for Clinical Trials.
Guidance for Biomedical HIV Prevention Trials, p 37-38: “Stakeholder education plan.”
Preparing a collaboration
Defining the interaction
Patients, patient representatives and industry should take responsibility to ensure interactions are meaningful by clearly defined processes and actions, progressed to timelines. In addition, all participants should be prepared for the interaction.
Prior to each interaction, agree mutually on (where applicable):
- The objective of project involving patients and/or areas of common interest to establish agreed structured interaction, providing all parties with necessary protection with regards to independence, privacy, confidentiality and expectations (see section 11. written agreement)
- The type of input and mandate of the involved person
- The tools and methods of interaction, e.g. types and frequency of meetings, ground rules, conflict resolution, evaluation
- Desired patient / patient partner organisation to foster long-term working partnerships, with independence ensured (in scope)
- The profile of the type of patient/s or patient representatives/s to be involved and their number
- How activity outputs will be used and ownership of outputs
- How and when the patient/s involved will be informed of outcomes
- Contractual terms and conditions including consent and compensation (see section 11, written agreement).
- Other elements according to the specific project
Preparing a collaboration
The four key principles for collaboration:
1. Clarity of Purpose
Each party should be clear about the reason for and the planned outcome of the collaboration – and the ultimate benefit for patients
Each party should act and be seen to act honestly and with integrity at all times
Each party should maintain their independence
Each party should be open and honest about the purpose of the collaboration and be able to account publicly for the associated activities and any exchanges of funding
Using this guide: a checklist
- Has there been a frank discussion about the purpose and expected benefits of the collaboration, and any risks, addressing all the issues in this guide?
- Are the objectives and planned outcomes of the collaboration specified?
- Are the roles of each partner and reporting mechanisms specified?
- Has a written agreement or contract been put in place, which sets out how each party will adhere to the four key principles?
- Is there a named senior individual accountable for managing and maintaining the relationship and monitoring adherence to the four key principles?
- Is information about the collaboration published on the company and charity websites?
- Can each party confidently explain the collaboration in public?
There are many ways to identify patients to be involved in an interaction. The main routs are through:
- existing patient organisations
- EUPATI or similar project
- advertising opportunities for patient participation
- existing relationships with healthcare providers, hospitals and researchers and other agencies
- unsolicited requests previously made by interested parties
- existing advisory boards / groups (e.g. EFPIA Think Tank, Patients and Consumers Working Party at the EMA)
- this party agencies
Defining role patients
Although you may not have selected the expert patients or patient groups (EP/PGs) yet, outlining their roles and responsibilities at this stage helps to define your needs. Keep in mind that EP/PG roles may vary at different of the program or may evolve in response to new requirements. Once selected, discuss the roles with your EP/PGs to clarify what they can contribute based on their unique expertise and experience and avoid misunderstandings at the outset, e.g., if they’re expecting to have a partnership role but you’ve designed reactor role (see Types of Patient Roles chart below).
|Trial or study participant