Medical devices have the rewarding power to save patients’ lives, but the journey to get the device to market can be long, frustrating and difficult, especially if you have not gone through this process before. To guide you through this process, finding the most qualified design & development partner/company, who can provide an experienced project manager (PM), will help you understand and walk you through the full scope of the project, including setting a realistic timeline, estimating costs and predicting risks. It’s highly encouraged that you work closely with a company and PM who specializes in your device as they will be able to provide invaluable knowledge and expertise that will ultimately save you precious time and money.
Before even setting out to find a development partner, you need to define your project goals, including defining your endpoint and then setting midpoints of how to achieve this, how you are going to raise funding or if you already have enough, how will you appropriately budget this funding and defining the issue the device is setting out to solve. Make a checklist to estimate the cost in between each milestone to give yourself a proper assessment of the total overall cost to determine how much funding is needed. If you have not done this before and are not sure how or where to start, interview a number of potential partners and consult with their PMs. A PM is like a housing contractor – they will help you manage your project to ensure your project is completed to the highest standard as they are also putting their reputation on the line.
To find the best PM for you, research multiple different potential companies, reach out to past and current customers to get their satisfaction and meet with your top few PM choices. Research should include reading through their blog posts and case studies to determine how they are positioning themselves as a company – are they talking about only the great things they did, or are they positioning themselves towards an informational stance and advising you to watch out for companies that will take your money and deliver a poor product. A company with more years of experience is more likely to know how to help you achieve your goals due to their extensive years of experience in the field. To determine how truthful a company is, especially in their case studies, look for specifics about the products they’ve built, the company who was the customer and if the device is still on the market today; if the device is still being sold, the owner’s name is public domain, so the PM should have no issue with Intellectual Property (IP) and citing the device they helped prototype, develop or manufacture. It’s vital that you trust the company that you ultimately choose since you will be entrusting them to deliver you a product without wasting resources. When you have a chance to meet with the company, either via a phone call, video conference or in-person, gauge how transparent they are, and therefore how transparent they will be during the project timeline. They will give you an estimate of their costs, but you will need to determine the value of their services and what you are getting for your money; keep in mind the cheapest is not always the best option as most likely you will have to go back and fix errors later if they rush through to conserve costs.
If you chose the right partner company and PM, they will provide expert insight into each phase of your device. They will help you set a realistic timeline depending on your project and help you to understand the full scope, such as the timeline, costs and risks. A relationship with a PM can sometimes require compromises and while they must listen to what your hopes are for the device, you also have to be reasonable about what you can achieve given your constraints. Since you should have already contacted multiple potential partner companies, you should not be too surprised to hear if a company is not able to achieve everything you wanted, often times because of the budget; if you spoke to reasonable, truthful companies, you should have heard this multiple times by now though. The right partner company and PM will do their best to ensure your device is ready on time and within budget, so spending a little more money to receive guidance will eventually save you resources. And the more efficiently and more on budget you get your device to market, the more lives it will help save, which is ultimately what medical devices are all about.