It is an exciting time to be in the medical device product development industry. With medical device technology evolving so rapidly, the sky is the limit provided one’s character has the ability and resilience needed to find the right resources to help build a medical device on time, on budget and then bring it to market.
We have worked on a number of medical devices for startups and small businesses and in that time learned a great deal about building a medical device with limited resources. Here are 5 helpful tips to consider when your team is ready to take on the challenge.
1) You Don’t Know What You Don’t Know
The statement seems obvious but to effectively bring a medical device to market on time and on budget, the learning curve is steep and you don’t want to learn what you don’t know on a tight time frame with limited funds.
Our advice: Look for help early in the game to help sidestep the pitfalls and deal breakers of medical device product development. Even if it’s just to make relationship for use at another time, gather as much knowledge as you can to limit your exposure to costly surprises.
2) Regulatory Red Tape Can Be Avoided By Being Smart About It
Regulatory red tape can stop a project dead in its tracks. This can be a major problem at anytime in the medical device product development lifecycle and even worse, after.
Our advice: Work with medical device regulatory personal early on in the process to help steer the product development in the right direction from day one. This will help avoid costly mistakes.
3) Work with experienced partners that have trusted relationships
Finding out that your sourcing solution or engineering team isn’t capable of delivering what they said they could halfway through your budget and timeline is a bad place to be stuck.
Our advice: Do your homework. Dig into their portfolios and check references. Get specifics of what they have done on projects they use for examples. Ask a lot of questions and don’t be shy or afraid to hurt feelings, this is your time and money. You deserve to know everything that you can.
4) Documentation, Documentation and More Documentation
Communication is key especially when dealing medical device product development. Along with the usual challenges of product development comes the added challenge of meeting regulatory standards both domestically and abroad.
Our advice: Document everything, keep a strict revision history to documents and hold individuals accountable for documenting procedures, agreements, and revisions.