Week 5: Implementing and Implants

The Importance of Implementation

With the Medical Device Industry gravitating towards innovation, optimization and branching out into emerging markets, it is essential as engineers to understand the implementation of a product. We often get caught up in the R&D aspect of engineering, but in reality, about 80% of the time invested in a product is spent on the back-end in manufacturing, regulation and marketing. The GMI students spent the week working with professionals from various companies (Hologic, Allergan, Moog) at Establishment Lab’s facility to understand the implementation process through ‘project-based learning’. This practical approach in using a modern product as a template for analysis would help us get a real-world feel for how the current process in the MedTech industry works.

 

Choosing our Product

The course required that we split into groups and choose a product that is relatively new, moderately complex and discloses enough information for us to pursue. After some deliberation amongst our group, we settled on analyzing Medtronic’s Activa PC, which is a neurostimulator used to treat illnesses such as Parkinson’s, tremors, OCD and depression. Deep Brain Stimulation is a field that is emerging and piquing the interest of various medical device companies, and for this reason, this product seemed like an interesting case-study.

Medtronic’s Activa PC Neurostimulator

Intellectual Property Search 

The first step in assessing our product required us to analyze the IP landscape of Deep Brain Stimulation technologies. Being that research is relatively new in this field, there were some relevant patents that could pose a risk to furthering developing the Activa product-line. With many patents still active, we deemed that the product had a relatively high IP risk. One patent that proved especially interesting was the Brio IPG patent by St. Jude (now Abbott). This product is a direct competitor with the Activa, and so we needed to develop a strategy that could help theoretically put Medtronic’s device in a leveraged position when it comes to integrating future technologies to their product-line. An offensive-blocking strategy is what we deemed would best fit this specific product. With Medtronic being a larger company, they have both the resources and capital to buy-out smaller competitors and also put research into future integration possibilities. This would increase the hold Medtronic has in this market.

 

Manufacturing Process & Material Costs

 DBS implantation can cost upwards of $30,000. Being a Class III medical device, we knew that there would be higher material costs associated with the procedure. We decomposed the main components of the device into the following:

  • Impulse Generator (Battery, Electronics)
  • Titanium Housing
  • Polyurethane-coated Leads
  • Platinum-Iridium Electrodes
  • Extension Wires
  • Packaging & Labeling

While this list is not exhaustive, it provided a starting point in estimating what labor, burden and material costs would be for this product. Operating under certain assumptions, we estimated a total LBM cost of $4040.00. With Class III devices generally returning 70-80% margins on their product, the $4,000 estimation seemed appropriate.

From a product risk standpoint, our team brainstormed potential failure modes for the device and developed mitigation plans to account for higher risks. These potential problems and their mitigations plans are listed below:

  • Short-circuiting of the Device : Voltage-limiting
  • Incorrect Electrical Impulse Generation: Signal Calibration after Manufacturing
  • Battery Failure : Warning System for Low-Battery
  • Displacement of Leads and Electrodes : Use of Better Adhesive Techniques

With the device being an implantable, there is already inherent risk in regards to infection and improper surgical implantation, however to mitigate the problems above, the solutions needed to be adequate enough to be deemed acceptable by review.

There are ways to optimize the material costs of the product. We proposed three specific ways in which this could be accomplished:

  1. Look for opportunities to reduce device size (i.e. battery size)
  2. Look for alternate bio-compatible material
  3. Develop an application-based programmer

Not only would this decrease overall material costs, these solutions could potentially expedite the manufacturing process by a significant amount.

 

Regulatory & Clinical Strategy

As aforementioned, being a Class III device, a premarket approval (PMA) would be the most viable option in getting regulatory approval from the FDA. Although this pathway requires more resources invested (i.e. clinical trials), being such a novel device would allow innovation and trail-blazing in DBS technology. Our predicate devices would be the legacy Activa model as well as the Brio IPG.

In regards for the clinical trial that would be necessary for the Activa, a randomized controlled-blinded study (for both the patient and outcome assessor) would be most appropriate. The patient could press a button that would or would not stimulate the GPi/STN of the brain (for Parkinson’s in this case) in this clinical trial. The outcome assessor would also be blinded to prevent any bias in data collection. The primary endpoint in this study would be to see improvement in UPDRS testing. The UPDRS scale rates the severity of Parkinson’s in a patient, and measures parameters such as motor function, speech, and posture on a 0-5 scale (with 5 being the poorest performance). A secondary endpoint would be a behavioral evaluation both before and after stimulation to ensure no unwanted behavioral changes occur. 

Sales & Marketing

An essential question to ask before marketing a product is asking ‘who are our stakeholders’? By understanding the target demographic of a product, a tailored sales and marketing strategy can be implemented very effectively. In our case, we identified the key stakeholders to be:

  • Doctors
  • Patients
  • Family of Patients
  • Payers (Government, Insurance)

A value disposition analysis of the product helped us better define the particular sales strategy we wanted to pursue. From this, we determined that a ‘Direct-to-Consumer’ approach would provide the best return on investment being that the device has a higher cost and higher efficacy comparatively to the medical device market. Lastly for the marketing strategy, mediums such as television, magazines, publications and the Internet can all be used to advertise the product and it’s immense potential. Also providing free training to doctors could also encourage the use of Medtronic’s device over competitor’s.

Firsthand Experience

After spending a week learning about the various aspects of implementation, we were graciously offered a tour of Establishment Lab’s manufacturing process of silicone breast implants. Before we could enter the clean room, we had to suit up, wash our hands and understand the protocol of what is allowed. It was in this moment that I felt the most germaphobic  I had ever felt in my life. But, I was truly encouraged as to the measures the company took in ensuring that their product was high-quality.

A silicone implant made by Establishment Labs

What I’ve Learned

This approach of project-based learning helped me realize several aspects of engineering that are not necessarily the most glamorous, but are definitely the most integral in getting a product to market. As Engineers, it is an obligatory duty to continuously be improving and becoming more efficient and as a Medical Device Engineer, the duty is all the more necessary. Every improvement has the potential to improve the lives of many. As I prepare to Intern at Boston Scientific, I hope that I can translate what I have learned in the past week and make a positive impact!

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