Clinical translation and human validation of a novel intradermal microneedle drug delivery device - ON-1263

Project type: Research
Desired discipline(s): Biochemistry / Molecular biology, Life Sciences
Company: Maman Biomedical Inc.
Project Length: Flexible
Preferred start date: As soon as possible.
Language requirement: English
Location(s): Kingston, ON, Canada
No. of positions: 1
Desired education level: PhDPostdoctoral fellow
Open to applicants registered at an institution outside of Canada: No

About the company: 

Maman Biomedical is a Canadian pre-seed medical device company developing a needle-free drug delivery platform, initially targeting fertility care. Its first product, Maman Port, is a proprietary hollow microneedle device designed to enable the intradermal self-administration of existing injectable medications without drug reformulation. The company is advancing its technology through preclinical validation, manufacturing scale-up, and regulatory development toward first-in-human studies and commercialization.

Describe the project.: 

This project will support the clinical translation of Maman Port from a functional medical device prototype to a clinically validated drug delivery technology. The research will be conducted in collaboration with clinical and academic partners, with activities based at Maman Biomedical's proposed research space at Helix Labs within Providence Care in Kingston, Ontario.

The project will focus on establishing the safety, usability, and performance of hollow microneedle-mediated intradermal delivery, generating evidence to support device design verification, regulatory submissions, and subsequent clinical investigations.

Research activities will include:
1. Preclinical and device performance validation: Develop and execute experimental protocols evaluating skin penetration, device integrity, delivery performance, tissue response, and reproducibility. Support quality control and manufacturing process validation of research-stage devices.

2. Clinical study development: Design early-stage human feasibility and usability studies, including clinical protocols, outcome measures, participant eligibility criteria, and research ethics submissions.

3. Human factors and patient experience: Investigate device usability, administration success, procedural pain, patient acceptability, and user preference relative to conventional needle-based administration.

4. Clinical evidence generation: Coordinate approved clinical investigations with hospital and academic collaborators, including participant recruitment, data collection, statistical analysis, and interpretation of findings.

5. Scientific dissemination and regulatory translation: Prepare research manuscripts, conference abstracts, technical reports, and clinical evidence supporting future regulatory submissions and commercialization.

The project is expected to generate publishable research demonstrating the feasibility and patient-centered benefits of a novel intradermal drug delivery technology, while establishing the clinical research infrastructure required for subsequent therapeutic studies.

Required expertise/skills: 

We are seeking a PhD researcher or postdoctoral fellow with training in biomedical sciences, clinical research, biomedical engineering, pharmaceutical sciences, or a related discipline. The ideal candidate will have:
● Experience designing and conducting human-subject research, clinical feasibility studies, or medical device investigations.
● Familiarity with research ethics submissions, Good Clinical Practice (GCP), clinical research protocols, and participant recruitment.
● Experience with quantitative data collection, statistical analysis, and scientific publication.
● Knowledge of drug delivery, skin physiology, biomaterials, or medical device development is an asset.
● Strong scientific writing, independent problem-solving, and interdisciplinary collaboration skills.
The successful candidate will work at the intersection of clinical research, medical device innovation, and commercialization, contributing directly to the translation of a Canadian-developed technology into clinical practice.