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Commercializing an Emerging Medical Technology: Not for the Faint of Heart

Updated: Mar 10, 2022

You are 12 weeks behind schedule and $2 million over budget, with no definitive solution in sight. Your development team has started to live in their cubicles, ingesting caffeine intravenously and neglecting any sort of personal hygiene. Some of them have even started to build small hovels under their desks using office supplies. The investors have moved from requesting status reports quarterly to weekly to hourly. Next week you will expect them to start monitoring the development team with web cams and wireless vital sign monitors.

One of the perks of your management role that they neglected to mention on the application is that regardless of why, it's still your fault. This is much more than another development budget. This will affect everyone you work with and their families. If this program fails, everyone is going home: game over, thanks for playing, do not collect $200 when you pass "Go."

You ask yourself, "What did the other companies do when they hit this problem? Whose solution was the best?"

Well, those questions are great to ask, but they are moot points. This is an emerging technology - there is no one to copy. You are working with something that has never been done before, breaking new ground and in med tech you are going to save lives. Emerging medical technologies are unlike any other development program. They are harder, cost more money, take more time, and have a higher failure rate. The upside is that if you are successful, you will be very successful.

Your situation may not be as grim or dire as the one described. The key to managing a project like this is to keep the team focused on specific deliverables and moving down the path to completing the project. This will be difficult at best.

There are several suggestions that you can follow to make sure that you do not hit a stumbling block:

  • Tell the truth. Let the investors know what the story is and make sure the investors and development team are on the same page. If you have been glossing things over or twisting the truth, come clean now; it will help in the end. Take the lessons learned from examples like the Allergan breast implant or Medtronic insulin pump failures. If there are any uncertainties or unanswered questions, the employees will waste time gossiping among themselves.

  • Use every resource you have. Your employees and investors are resources to be used during any development process. Even the most illogical suggestion can be transformed into a groundbreaking development. Manage the team, but do not stifle creativity.

  • Take a step back and prioritize your challenges. Use a structured development technique which will include a task list. Assign each task to a resource along with an importance to them will make them both accounted for and achievable. Most people are overwhelmed when they think about all the issues and problems they must solve as a collective group. Make a list, identify the target, and attack that problem until it is solved. If it works for Microsoft, it will work for you.

If you are in the situation:

Get the help you need. If your team has reached its limits, replace them, or bring in an expert development team. Find a group with the required skills who will offset your team's shortcomings and make things happen. When the future of the company is on the line, it is no time to rely on people because they have “good intentions”. Bring out the big guns because you will pay now or later, make your choice.

Northeast Biomedical is a medical device product development and contract manufacturing company that works with companies at all stages of development. Our development process is ISO 13485:2016 certified. We have the ability to augment your efforts with our expertise to help you get your projects to the next stage in an efficient and timely manner.

We offer product development services including:

  • Electromechanical Instrumentation Design & Development

  • Product Development Services

  • Disposable Design & Development

  • Low Volume Contract Manufacturing

  • Ideation Workshop

  • Engineer on Call Service

We have a team of highly skilled engineers who specialize in the design and development of medical products and equipment.

We have worked on a variety of projects in the life sciences space including catheters, disposable devices, sensors, ultrasound integration, optical fiber and laser products, instrumentation, surgical tools, point of care products, podiatry devices, test fixtures, surgical robots, machine vision, and automation equipment. Our website has information about us and on our approach to projects.

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Great article Tim!

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