Exclusive interview with product development expert and newest member of the Advisory Board: Addie Harris.
Utrecht, October 6, 2022 – The Advisory Board of MRIguidance recently welcomed Addie Harris, a leading product development expert in Robotics and Augmented Reality devices and software for orthopaedic surgical applications within MedTech.
Ms. Harris holds a degree in Mechanical Engineering with focus on Robotics from Tufts University and has a background working on foundational, disruptive products in a variety of start-ups, both in medical and non-medical industries. Most recently, she created and led the team that developed Johnson & Johnson’s VELYS Surgical Robotic System for Total Knee Arthroplasty.
In an exclusive interview, Ms. Harris explains her reasons for joining the Advisory Board of MRIguidance, discusses the next steps for the company within the US market and the future of BoneMRI.
We know that any radiation exposure increases cancer risk. The ability to avoid radiation is greatly desired. The additional benefits of gaining a soft tissue standard MR image make this technology advantageous.
You are the newest member of MRIguidance’s Advisory Board. What motivated you to join?
I was introduced to the technology by Dr. Poelstra, and was intrigued by the reduced/eliminated radiation for spine and bone based surgery.
You have a background in robotics and augmented reality for orthopaedic surgical planning. Do you see a way BoneMRI could relate/be integrated to these topics?
Robotics and AR in orthopaedic surgical planning requires an accurate image of the patient’s anatomy, which is how it piqued my interest.
With your expertise as product developer of medical devices you are aware of the stages and challenges a product has to go through. Could you name the ones you foresee for BoneMRI?
BoneMRI has made it through some of the major product development challenges, such as FDA clearance and CE Mark. These two major hurdles legally open the door to the biggest WW markets, and indicate that MRIguidance has the capability to take engineering and scientific concepts and develop them into a safe and effective medical technology.
The next phase is expanding indications, resulting in further regulatory clearances, and integrating BoneMRI into surgical solutions that need the bone image.
Do you think the US market is prepared for a product like BoneMRI? Why?
Absolutely, yes. Current standard of practice requires a radiation based image for all orthopaedic procedures. Not all require the heavy radiation and 3D imaging of a CT scan, but an X-Ray is always the first step. We know that any radiation exposure increases cancer risk. The ability to avoid radiation is greatly desired. The additional benefits of gaining a soft tissue standard MR image, make this technology advantageous.
What is the biggest challenge you see for BoneMRI in the US market?
The challenge is sales and support and partnering with the big strategic players. The big players will open the door for sales, and also provide the needed in the field support.
BoneMRI could become the benchmark for low radiation or even no radiation surgical planning and navigation.
Is it relevant/important to the US market to have a radiation-free imaging solution? Why?
It is a very relevant addition for the US market. Surgeons and radiologists themselves have concerns about professional exposure to radiation, which speaks to the overall concern in the medical field. Imaging is an important diagnostic and surgical tool. Bony images have always required radiation, and the ability to get this same information without the radiation changes benefit risk exercise. The next step will be easier access to MRI devices, expanding indications for use, and reimbursement models.
How will the FDA embrace solutions like BoneMRI? Do you think they understand the advantages of such an innovation?
Like other newer software-based technologies, the FDA will need to expand their understanding and consider how they evaluate the safety and efficacy of the device. The FDA’s commitment is evident in the working groups they have in many of these areas.
How should such a solution be rolled-out in the US market? Do you think people will need training or can it easily be adopted by end-users?
It’s not so much that staff need training, as the hospitals and imaging centres require training on new devices and protocols. The mark of a robust training program is using several modalities that meet the market’s needs and insure competition and confident use of the product. These training methods may include modalities, such as self-study, virtual, in person on site and in person offsite, in order to meet each product user where they can best learn the material.
Do you see BoneMRI playing a big role in the future of medical imaging?
Although there are more imaging options, BoneMRI could become the benchmark for low radiation or even no radiation surgical planning and navigation. As mentioned, there is a lot of work to be done in terms of market entry and commercialisation, but I foresee a bright future for BoneMRI in the CAS space!