June is the month of many university graduations. In the spirit of continuous education, we asked our writers to identify medical device project tips they’ve learned from on the job experience. Here are 11 solid tips that will help you commercialize your medical device.
Beware of unrealistic timelines. Novices love to have things on the market in a year. It sounds good, but in general, medical devices never get on the market in a year. Skip the enticing artificial deadlines and create a realistic plan with the help of experienced experts.
Avoid gaps in projects. First time entrepreneurs often request us to rush and build a prototype in eight weeks, but they forget it will take 3 months after the prototype is completed to raise their next round of funding. The biggest impact to overall timing is not whether you can shave a week or two off of development, but avoiding funding gaps that often impact availability of keeping your original resources as they are likely engaged in other projects. Plan your project and financing in clear stages.
Use a single project manager for both the entrepreneur and contractor’s team. Often things are hectic in entrepreneurial and start-up companies. Identify client and contractor activities and critical actions that impact the project schedule. Consider using your contractor’s project manager to help manage these activities in both organizations. This can improve critical timelines and overall costs.
Exchange innovations and regulatory requirements right at the beginning. Medtech entrepreneurs know their stuff really well and medical device engineers know the regulatory and device requirements. Share information with the whole team as soon as possible so the course of development will not need to change course. This will deliver the cheapest, fastest timeline for medical device projects.
Market research and product strategy are important. It’s a great idea, but what’s the market potential? Be sure to stop and figure out if the market is viable. For example an injection molded device is going to be expensive. Are physicians willing to pay for it?
UX (User Experience) can be improved by adapting to current clinical workflow. Sometimes standard ergonomic design rules should take a back seat to existing clinical use practices. A user Interface (UI) following design convention was originally located on the right side. However, the clinician entrepreneur created a wireframe of his ideal UI on the opposite side. Why? Because it fit the current work flow better. Psychological comfort with current workflow outweighed standard design for this device.
Don’t underestimate the importance of documentation and regulations. Medtech entrepreneurs who don’t understand the extensive documentation requirements for medical devices are often surprised and at a disadvantage. “I have a device. I made it. Here it is! I want to submit it.” When asked if they have a DHF (Design History File), their reply is, “No. We don’t have a design.” Not understanding this integral part of medical device commercialization will cost time and money.
Understand the impact of regulatory work and regulatory classification of your device. The device class and regulations drive which kind of data is needed and how much money will be needed to get that data. When developing a device, always determine what class it will be. That will answer questions like “Will it require clinical studies?” You may think your device is something simple and straightforward, but in fact, it may not be. In your business model make sure to include the time, cost and cash needed to cover the regulatory requirements.
Consider joint clinical trials that can work for multiple countries. A solid regulatory strategy can save money on testing. Run trials that will apply for all of the countries where you plan to launch product. You can save a lot if you take time to look into your strategy and plan in advance.
Medical devices are not clinicians. This is the key risk/regulatory challenge. It is not intuitive because the clinician knows their field very well. They can do something, but the device can’t. Often a device cannot receive approval for applications and procedures that clinicians perform in routine practice. A clinician might be able to nick your teeth occasionally to get the job done efficiently, but if you make a drill that nicks teeth occasionally, it will never get regulatory approval. Experienced medtech entrepreneurs understand this, but first time clinician entrepreneurs are often surprised at the importance of risk mitigation.
Similarly, a device may be designed to work perfectly, but be used incorrectly in the work environment and cause damage. For example, an operating room device works perfect and is designed to be located at the head of the OR table is duck taped to the bottom because the OR team feels it will work better for them in that location. They get away with it and think it is fine, but in reality you can never design a device, include a roll of duct tape and say, “Here you go, use it wherever you need.”
Use field studies and user interviews. When participants ask if they can use a device in a certain way because that’s how they currently do it. Explain why it can’t be done and describe the regulations. If they respond, “Ok, well I can do whatever I want in my OR, acknowledge there are two lines of thinking. Then find a way to make a device that meets both the regulatory needs and user requirements.
We hope our writers’ on the job tips help you commercialize your medical device projects. Please share any that we may have missed, or contact us to set up a free project consultation.
Astero StarFish is the attributed author of StarFish Medical team blogs. We value teamwork and collaborate on all of our medical device development projects.