Situation / Task

This preclinical stage venture-funded startup company was designing and testing its prototype intra-luminal tissue ablation device. In the early stages of their technology development, expensive, large animal studies were the only way to test the performance of candidate device designs. I was asked to design and build a laboratory setup that could replace most of the large animal studies with a tissue-equivalent ablation phantom, instrumented to measure device performance.

Action

I designed, built, and tested a very sensitive laboratory apparatus, which included a tissue-equivalent ablation phantom, to measure the ablation power of their prototypes.

Result

The company used this apparatus for approximately 2 years to rapidly test prototypes and design changes, prior to the design freeze and an application to FDA for a first-in-human study.

Situation / Task

The client had just licensed intellectual property from a university hospital for an implantable neuro device and had raised seed funding for their medical device startup company. They partnered with an engineering design firm to create design concepts, select the most promising designs to prototype and demonstrate early technical feasibility. The client was disappointed with the slow pace of progress, was not sure about the quality of the work, and started to question if they selected the right design firm. I was tasked with performing an evaluation of the design firm and its progress to date.

Action

As part of this work, I performed an onsite visit to the design firm which included a full design review and audit of the work to date and interviews of the key technical contributors.

Result

During my review, I found the design concepts to be very abstract and challenging to manufacture and implement in practice. The large design firm was not giving the client the focused attention that the project required. On my recommendation, the client terminated the development contract. In the meantime, I was able to find a more suitable design firm that met their needs with whom they are still successfully working now 7 years later.

Situation / Task

This venture-funded client had licensed university technology and was developing a device-biologic combination product to filter pathogens from the bloodstream. While the company leadership included world leaders in the field of infectious diseases, they lacked expertise in the development of clinical medical devices. My task was to lead the device design, engineering, testing, and manufacturing to produce combination devices that could be used in a clinical study.

Action

This was a multi-year project which at times required full-time effort. The client was an entirely virtual enterprise. In my capacity, I developed the design history file, led and coordinated a number of external contract design, testing, manufacturing, packaging, and sterilization vendors as well as quality, regulatory and clinical consultants.

Result

GMP-compliant biologic-device combination products were produced on schedule and the client received FDA IDE approval for a first-in-human study that has since been completed.

Situation / Task

This venture-funded medical device startup licensed brain cooling technology from the Massachusetts General Hospital to treat stroke. They needed to develop a preclinical device to test during a large animal safety study and complete product development for a first-in-human study.

Action

This was a multi-year project and I served on the company’s Scientific Advisory Board. In this capacity, I consulted on device design, bench-top testing, animal testing, FDA submissions, and clinical studies.

Result

The company developed a clinical device, obtained FDA IDE approval, and completed its clinical study.

Situation / Task

The client law firm was defending a surgeon in a malpractice case. The plaintiff argued that, in the use of a medical device, the surgeon did not follow the manufacturer’s instructions and this caused the patient to suffer a serious adverse event. I was hired as an expert witness for the defense to verify that the physician followed proper procedures.

Action

For this client, I reviewed the surgeon’s operative notes and the patient records. With these and the medical device instructions for use, I was able to verify that indeed the defendant followed proper procedures. In addition, at my request, the defense subpoenaed tissue samples taken from the patient. I was able to send these to a pathologist with whom I had worked with in the past, and he concluded that the serious adverse event was most likely due to an anatomical anomaly present in the patient before treatment. These findings were represented in my expert witness report and described during my depositions.

Result

The parties settled out of court.

Situation / Task

Hologic required an expert witness for their ongoing patent litigation with Minerva Surgical related to uterine ablation. Hologic sued Minerva Surgical for patent infringement in federal court based on patents that Hologic acquired from NovaCept. Minerva then petitioned USPTO Patent Board to perform an Inter-partes Review of the validity of the Hologic patents. Since the Minerva Surgical founders and leadership team were also the original inventors of the NovaCept patents, this called into legal question whether one could sell a patent and later try to invalidate that same patent.

Action

This was a multi-year consulting engagement working with Hologic and their attorneys Arnold & Porter. The totality of the legal proceedings covered several Inter-partes reviews at the Patent Board of the USPTO and litigation in US Federal Court.

• Hologic, Inc. v. Minerva Surgical, Inc., No. 15-1031-SLR (US District Court, District of Delaware, Apr. 24, 2017)
• Minerva Surgical, Inc. et al. v. Hologic, Inc., IPR2016-00680, IPR2016-00685, IPR2016-00868
• Hologic, Inc. v. Minerva Surgical, Inc., No. 2018-1550 (US Court of Appeals for the Federal Circuit, Apr. 19, 2019)
• Minerva Surgical, Inc. v. Hologic, Inc., No. 20-440 (US Supreme Court, Apr 21, 2021)

For the client, I reviewed the opposition’s briefs, strategized with the legal team, wrote several expert reports, and was deposed.

Result

This case became one of the most significant patent law cases in the medical device field of late. Hologic eventually won the case before the US Supreme Court with a vote of 5-4.

Situation / Task

A healthcare investment firm needed help with diligence on a pre-IPO medical device company before it would consider a significant investment. The target company had just completed its pivotal clinical study and received FDA approval. They were raising money to fund their commercial launch and the investment firm wanted to know the risks associated with the commercialization of the company’s products and the revenue potential.

Action

For this project, I reviewed the target company’s confidential commercial strategy plan, reimbursement landscape, clinical trial data, and publicly available sources on the competitive landscape. I developed a multi-year estimate of the company’s likely future revenue. My analysis was summarized in a report and presented live to the investment committee.

Result

The investment firm invested over $40 million in the target company and a successful IPO followed.

Situation / Task

A venture capital firm was considering an investment in a startup developing a gene therapy, delivered via a custom medical device. This VC firm had significant prior experience in the gene therapy field and already had an existing stable of biologics consultants to perform diligence on the gene therapy, but they did not have significant medical device experience. I was hired to lead the medical device portion of the diligence for this potential investment.

Action

For this assignment, I reviewed the company’s device design history file, its patent estate, and its preclinical data, I interviewed the company’s management team and wrote a diligence report which I presented to the investment committee.

Result

The venture capital firm elected to not invest in this opportunity.

Situation / Task

This publicly-traded investment firm wanted to incubate a medical device company in the dermatology space. I was hired as a consulting “Entrepreneur-in-Residence” and interim CEO of the new startup.

Action

In this role, I identified the intellectual property to license, engaged the IP owners, negotiated license agreements, solicited proposals from product design firms and market research firms, recruited members of a scientific advisory board, and prepared the presentation for the investment committee.

Result

The investment committee approved the seed funding of $1 million to start this company, however, soon after, the investment firm divested all its life science assets and did not pursue this opportunity.