The open technical questions I have not answered yet

Everything else I publish states what the record supports. This states what it does not. Eleven questions across the three technologies are genuinely open — some because the work has not been done, some because it has been done and not published, and some because the answer may turn out to be unwelcome. Each is written as a question rather than left for a diligence team to find.

Why publish this at all

Two reasons, and neither is modesty.

The first is that every one of these questions will be asked eventually, by a licensee’s engineers or a reviewer or a regulator, and the answer they get should be mine rather than a guess. A gap someone else finds costs more than a gap you declared.

The second is that the strength of a claim is set by the weakest thing standing behind it. Publishing the open questions is what makes the closed ones worth something: if I will tell you what I cannot show, you have a reason to believe me about what I can.

On the medical device

The device is regulated as a Class A medical device in India, is manufactured within an ISO 13485:2016 quality system, and measured 1.3 µA of leakage current against a 10 µA limit in IEC 60601-1 testing at a NABL-accredited laboratory. Those are electrical-safety and quality-system facts. None of them is a clinical fact.

  1. There is no published randomised controlled trial, so the efficacy question is unanswered. Not answered unfavourably — unanswered. Any statement about clinical benefit is at present a hypothesis.
  2. The proposed mechanism is proposed, not demonstrated in humans for this device. The underlying physiology of transmembrane potential is well established in the independent literature. What has not been shown is that this device, at its recited parameter ranges, moves that physiology in a person in a way that matters clinically.
  3. Which of the recited parameters actually does the work is unknown. A claim defines a legal boundary; it does not identify which variable within that boundary is the active one. A dose-response study would answer this and has not been done.
  4. The comparison against TENS has not been made experimentally. They are separate modalities and results do not transfer between them — which is why I never cite TENS evidence in support of the device. The head-to-head study a sceptical reviewer would ask for first does not exist.
  5. There is no long-term safety follow-up. Bench electrical safety is established. Safety over years of repeated use in a population is a different, longitudinal question and no such dataset has been published.

On the Hybrid Power Pack

The architecture pairs an electric double-layer capacitor bank with a battery so that transient current is absorbed by the capacitor rather than the cells. The physics of that is not in dispute. The engineering questions that decide whether it is worth building are another matter.

  1. The cycle-life benefit has been measured, but not across the range of duty cycles that would settle it. The pack has been cycle-tested at CIRT and environmentally tested at DRDO R&DE(E). Those are test reports, not certifications, and a test report answers the question its protocol asked. How the benefit scales across real duty cycles is open.
  2. The cost question is not settled and it is the one that decides adoption. A capacitor bank adds bill-of-materials cost, volume and mass in exchange for cell life. Whether that trade is favourable depends on the cell chemistry, the duty cycle and the replacement economics of the application. I do not have a general answer, and I am suspicious of anyone who offers one.
  3. Optimal sizing of the capacitor buffer remains an open design problem. I have published the first-order method I use, which is a starting point rather than an optimum. A proper treatment would be a control problem over a statistical load profile, and I have not solved it.
  4. Thermal behaviour of the combined pack over a full service life has not been characterised. Environmental testing establishes that a pack survives defined conditions. It does not establish how the thermal profile of the two storage elements interacts as both age, at different rates, in the same enclosure.

On OMNIA Drive

  1. It has not been built and run at scale, and nothing I publish should be read as saying it has. The architecture is granted in India, the United States and Japan; outside those three the family is substantially lapsed, stated plainly on the patent register rather than left out. A granted claim is a legal position, not a product. There is no independent third-party evaluation of OMNIA Drive anywhere.

And one that applies to all three

  1. Almost all of the evidence is first-party. The patents are examined by offices, the licence is issued by a regulator, the test reports come from independent laboratories and one review is indexed in PubMed via PMC. Those are real external checks. But no independent research group has replicated any of this work, and no peer-reviewed publication by an unconnected author evaluates any of the three technologies. That is the largest single gap in the record, and it is not one I can close by publishing more myself.

How this list will change

A question comes off it only when it is answered and the answer is published with its source — not when it becomes inconvenient. If an answer turns out to be unfavourable, it will be published as an unfavourable answer and the claim that depended on it will be withdrawn everywhere. Anyone conducting diligence is welcome to work from this list; if a question that should be on it is missing, that is an omission rather than a decision, and I would rather be told.

Originally published at https://hemant-rohera.vercel.app/open-questions.html — this is a copy for readers of this blog. The canonical version, with structured data, is on the hub.

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