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Health technology consulting

Medical device manufacturers need to subject their products to a clinical evaluation. A strong clinical strategy gives you a competitive edge by hastening the release of your device into the market and reinforcing distinctive claims with credible clinical evidence. For example, in the EU, a new medical device's CE marking process must include Clinical Evaluation as a crucial step. In some parts of Africa, pilot testing of all health tech innovations and approval from the Ministry of Health is required. Healthcare systems must assess the safety and efficacy of developing healthcare technology as it comes into sharper focus to fully utilize new technologies for improved treatment and lower costs. In assessing new medical technology, it's critical to find the correct balance between efficacy and effectiveness. We support health innovations aiming to improve access to health information and services in resource-limited settings.

The clinical evaluation of medical devices serves the following objectives:

  • To show that the clinical benefit of your medical device is provided to a sufficient extent.

  • Ensures your medical device doesn’t have any unintended or unwanted adverse effects.

  • Evidence-based claims strengthen the validity and acceptability of your device.

Are you a medical device startup or scaleup innovating for health information and services, with an impact affinity to underserved communities? Here is what DPM can do for you:

  • Strategy writing and consultation

  • Clinical evaluation implementation (project management)

  • Strategy audit and reporting

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Laparoscopy for emerging markets-LORESA

(Ongoing)

Projects

Managing director of LORESA

Improving access to gasless laparoscopy in low-resource settings using a mechanical retractor (RAIS)

Kangaroo care for premature newborns- Babymoon Care

(2021-ongoing)

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Development and implementation of the clinical strategy for their compact baby carriers.

Project management of their clinical validation project in Tanzania

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