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Q: What do you mean by medical device?
A: Believe it or not, everything from a simple bandage to a surgical robot is considered a medical device. For a formal definition, check out the FDA or ISO websites. The short answer: they are the tools, equipment, supplies or even software that are used to diagnose, monitor or treat a patient. In some countries, medical devices come with strict regulations and bureaucratic approval processes. Elsewhere, there is very little oversight and it is up to the company to maintain high quality standards and safe practices. MorseCode Medical builds medical devices to our internal standards, which meet or exceed regulatory requirements. Q: What does MCM do?
A: MorseCode Medical specializes in the commercialization of medical devices designed for global health environments (DfG), especially low resource settings. We help doctors and nurses find the tools they need to be successful from procurement to clinical use to service & repair. MCM doesn't stop at prototyping. A great design is a good start, but medical devices need to be reliable and manufacturable at a low enough cost to integrate into the local ecosystem. This is accomplished through experienced engineers collaborating with clinicians and supply chain partners to create elegant and efficient designs that get the job done without all the bells & whistles driving up the price. Then rigorous evaluation per international standards ensures quality you can trust. We also establish in-country manufacturing to provide jobs and reduce supply chain risk within the ecosystem. Next is the sales and distribution, which often requires a very different approach in emerging markets. Finally, post-market surveillance, service and repair including training local biomeds. We take a full lifecycle approach which is not only better for the health system, but builds human capacity. Q: What is DfG?
A: Design for Global Health Environments (DFG) means quality products that can handle power surges, rolling black-outs, lack of climate control, intermittent internet connection and other environmental concerns not typically accounted for. They are products that optimize for ease of service and repair, supply chain access to spare parts and minimize dependence on disposables. If most of the products on the market today are meeting your needs, DfG is not for you. If you find yourself frustrated that the products you have access to can't handle the conditions you work in or rely on parts you can't get, DfG might be the answer. Q: What do you consider a "low resource environment"? A: Essentially, it is a situation in which medical providers are practicing medicine without all the necessary tools that are commercially available due to cost or performance constraints, lack of trained personnel, or supply chain challenges. Many of these environments will also require DfG devices, but low resource environments can be found anywhere, including climate-controlled environments in countries with established infrastructure. Think of a free clinic or a rural office only staffed part-time. MorseCode Medical devices can be useful to any low resource environment, but MCM prioritizes supporting healthcare professionals in LMICs where most patients live at Rosling level 1 or 2. You sound great, but I'm not in a low resource environment.
Can you still help? No problem. We'd be happy to help. Find us at M&M Consulting where we assist US start-ups and medium businesses in commericalizing and optimizing their designs for manufacturability. |