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Medical Device Innovation Course

Course numbers: MIME 4920

Description: Undergraduate and graduate students from colleges of Business, Engineering, Law, and Medicine can take this research-based course. The students will need to apply and get admitted to the course prior to the registration.
 
The applicants should have interest in medical device innovation and exploring commercialization potential. The students will work in groups. The goal for each group of students is to work on the testing and meeting standards for a medical device following the lean launch pad methodology. The project involves applied learning and meeting with healthcare professionals. The applicants can count the experience as an independent study, technical elective, research hours, or towards required co-op hours. The course requires spending a minimum of 200 hours during the semester.

Lectures: Every week the students will receive lectures from experts in the related fields.

Application: Applicants should send a resume to mohammad.elahinia@utoledo.edu.

Medical Devices

At the Nitinol Commercialization Accelerator we have conceptulized, designed, fabricated, tested, and translated for commercialized a series of medical devices based on the use of Nitinol. We have publications on these devices. Please contact us if you need further information.

Active Pacing Wire

Ankle Foot Orthosis

Intr-VAD Ventricular Assistive Device

Intervertebral Disk Replacement

Minimally Invasive Thrombectomy Device

Organ Positioner

Patient Specific Implants

Pedicel Screw

 

Medical Device Innovation

In addition to the technical ‘know-how’ and the necessary capital investment, the success of a medical device company in bringing innovation to the market hinges on the following studies and assessments. In collaboration between colleges of medicine, engineering and business, we offer a comprehensive approach to companies and innovators:

  1. Patent strategy: the issues include the following assessments: protection possibility, the countries were protection is needed, breadth and depth of patent strategy, blocking patents and possibility of infringement, freedom of practicing the patent, and working around existing intellectual property.
  2. Market analysis: particular attention should be paid to overall prevalence of the device under development, overall incidence, and the size of market. c. Competitor analysis: history is the major consideration to evaluate the success and failure of other companies in developing similar devices. Alternative therapies should also be considered. Also the competitor landscape and timing should be evaluated.
  3. Customer evaluation: for the success of a new device it should be noted that the physicians’ main concerns are: betters outcome, decreased procedure and follow up time, and safety. While patients share similar concerns along with issues such as pain and side effects. Health care providers’ interests are similar along with the cost of the device.
  4. Regulatory pathway evaluation: this is a major defining step in the fate of any new device development as it significantly changes time and cost of the development. Devices fall in three classes according to the FDA with two regulatory submissions processes. For the 510k process, the evaluation time is more than 90 days while for the PMA process this time id more than 180 days.
  5. Reimbursement and coding analysis: appropriate coding or lack of coding influences value of the device. It should be noted that anticipated high cost of device may not meet code, the ICD-international classification of diseases as well as procedure or diagnostic codes affect the reimbursement.
  6. Financial projection: market penetration of a new device is major factor in the financial health projection of a start up company. Every innovative device will have a limited time to enter and penetrate the market in competition with the exiting and the newer technologies that will appear.
  7. Strength, weakness, opportunity, and threats analysis: these series of analysis summarizes and is partly based on the results of the previous analysis.

The medical device evaluation collaboration provides these analyses for medical device companies, faculty, and entrepreneurs in a cost-effective way. University scientists, physicians, engineers with new ideas for an innovation or a process are the main clients of the lab. The laboratory also provides rapid prototypical and testing services as part of the evaluation process.