Kiran SM Here is an example from my earlier experience in aerospace. If an aeroplane were to be manufactured now for the first time, the purpose of the PoC would be: 1.) to demonstrate that Bernoulli's principle can be applied to make aeroplanes fly safely ; 2.) to show that aeroplanes can indeed be manufactured ; 3.) to educate stakeholders like the people funding the project how aeroplanes would look like. For medical devices, any new idea for a product or a significant modification of an existing one may require a PoC.

Julie Omohundro Kiran, thanks for sharing your experience in aerospace, which is probably applicable here, too. Just to clarify, I wasn't looking for the specific objectives a PoC might have (eg, demonstrate Bernoulli's), but why do a PoC, rather than just forge ahead without one. Your point 3 (to educate shareholders) is an example of this.

Julie Omohundro To put it another way, what exactly does PoC contribute to the design and development of a product? Is it just a security blanket? A prop for a pitch? Or does it have a more tangible/technical contribution?

Proof of concept also help the stake holders involved in risk analysis and usability assessment to look at potential failure modes, hazardous scenarios, worst case use scenarios in a more comprehensive way...PoC also help mitigate design risks if any, before getting into the full product design mode.

G M Butcher The POC experimentally demonstrates the idea/new design/etc. can work. It is a pre-development stage activity, and therefore excluded from regulatory control. The POC is done when there is a 'new' application of an existing engineering or scientific principle. So one proves the 'new device' operates within the constraints of that principle.
The next step after that is to show that the product can be manufactured by creating a prototype and applying manufacturing engineering principles. Then development starts based on that initial design attempt, and when the decision to make/market a device is made, along with the usual beginning development phase activity.
While any of these can and should be used afterwards for business purposes, that is not the first intent of a POC exercise.

For medical device NPI @new product initiative is normal process after I released several new products in global manufactories.

Oftentimes a PoC is crucial when presenting a new, disruptive technology or product. Especially when coming from R&D where the work is likely to be less management directed and more investigative. It can be key in conveying a new idea to stakeholders that will decide whether or not to further fund the development.
It can also be extremely valuable in getting early feedback from potential end users.

Alberto Paduanelli PoC is really more for manufacturer than regulators

PoC is so that you don't waste money on something that is not going to work (functionally) or there's no market for. It's really a financial safety measure. You can typically create a PoC that is 60% operational with 10% of the cost.

It also helps to scale the challenge. In the realm of energy-based devices the power required for a specific tissue effect is often unknown even to an order of magnitude. So the PoC (through physical or virtual prototyping) helps to bring a first order understanding to the undertaking.

Agree with Sagar, Butcher & Alberto. FDA do not ask for test results performed in ‘investigation’ of P.O.Cs. As Sagar said, having a proto handy gives better understanding of hazard analysis. Even KOLs can help here. Marketing with a toy in hand can say if it can be sold. Most importantly for R&D, we can find out what is lagging in design perspective, before we propose it further to sponsors and potential customers. As basic design principles say, with design still on board, impact of change is least. There are many ways now, to check the design, for example virtual reality, to demonstrate concept rather than manufacturing it.

Proof of concept is just for the business or investors to gain confidence in the final result. Many times the science does not need a proof of concept. The real reason a proof of concept occurs lately is to gain traction and secure funding and support.

Agreed Julie - let's forge ahead without POC. Now let me just check those Theranos shares....

Roger Cepeda, JD, MBA, RAC I would say it's to retire risk. Whether you are deciding whether to invest in a patent, invest in a company, or invest in market research, people with previous experience will rattle off the potential problems, and no level of enthusiasm or faith can address that. You need data, and a prototype is a milestone in that process. The point where you need PoC is when you can see a roadblock that is looking for evidence, albeit early stage info.

PoC has a number of benefits. In our experience at MD Invent Solutions, one of the most important of these is opening the eyes of all the stakeholders as to what the product is and how it works. Over the years it has been surprising how much understanding is often lacking prior to the PoC being put in everyone’s hands and how much is gained with the tangible PoC. It’s an invaluable step in the process.

Running a randomized controlled clinical trial is expensive and time consuming. Having a proof of concept, or small pilot, lowers the risk and manages expectations.

Often to build confidence to commit development resources (against other projects), to de-risk and better understand the challenges and likelihood of market, technical and economic success and can the project be delivered within a given time frame. Fundamentally moving from unknowns to knowns, reducing guesswork!

https://www.fda.gov/ForPatients/Approvals/Devices/ucm405378.htm

Kyle Nevala Oh, Julie, what a great question!
Am I reading into this too much, or did you say, 'Outside the Industry Investors'. So, now I see 2 parts to this conversation:
1) investors = ROI
2) stage gate and investor progress milestone timelines
#1 is easy: where's the money, Jerry?!?
#2 now deals with what type of regulatory pathway the device is taking.

Simple, competitive, market saturating, me to product? What's the purpose of doing a POC? Everything can be done virtually and, with an experienced team, go straight to market with approval.
I would assume an investor dipping their toes in the pool for the first time wouldn't want to dive into the deep end having a more secure (or lower risk) experience. The next one, who knows, right?

PMA. Again, depends on product life cycle. Some very established products: PMA path. Again, experienced team, virtual development to human trials. Purpose of a POC for this scenario? IP verification?

PMA pathway for a newer concept?

IDE pathway?

My thoughts seem to converge on a more educational approach with the investors for the product's approval pathway and need for a POC.

POC, absolutely in some cases.
POC not needed in others.
Though a prototype is always fun to develop and play with.

Patent offices sometimes (rare) may require some evidence that the technology that is attempting to be patented actually works. Otherwise, they may hold an invention as not being patentable subject matter or non functional.

Julie Omohundro Many very helpful and informative answers here!

I will explain that I asked the question because I was doing some thinking around proof of concept and design controls, realized that this was a question I wasn't sure I knew the answer to, and decided it would be a good one to put to this group. Clearly I was right about that!

Ingrid's link leads to an FDA page that describes POC as a document. I must say, I've never thought of POC as a document. I've never seen a POC document, but perhaps that's not something Regulatory would see. Regardless, I wouldn't think of the document as the POC, but as a document that describes the POC.

What about the rest of you? Do you think of POC as a document? Do you normally expect a document to be associated (if not necessarily equated) with POC? Or is it sometimes enough just to see it in action and all parties are satisfied and so no reason to document it?

John Gillespy Lots of great perspectives. For new devices I visualize 2 proofs of concept--the first demonstrates it works as intended ("device POC"), and the second shows the market is interested ("sales POC").

Andy Carter One critical aspect of medical device product development under an FDA compliant design control system is defining the start point. Nothing prior to the start is undertaken under design control, but after all is, and all is submittable to, and reviewable by, the agency. Prior to the start of product development you are doing a research project, deciding for example which one of four different polymer chemistry approaches is expected to yield required performance, or showing in a small animal study that the device does work. You do not want to do your research under design control for lots of reasons. Having a documented Feasibility Report is a good entry point into design control particularly if you have a stage gate system as part of your management. One other point to consider is that the product itself is in effect a document - The Device Master Record is what defines the product and how to make it - in effect a pile of paper - or whatever the electronic equivalent is.

For me it has always worked more as a proof of feasibility. Feasibility of the users to use it as conceived and highlighting gaps in understanding along the way, also the market feasibility of users willing to put money into it. It is a two way value highlighting process for both the users and the company.

Gregory W. If there is not a proof of concept completed the entire discussion ends. Without out it all one has is a dream... It all starts with a confirmed POC. [This was ONE reason the Theranos story was so intriguing and disturbing]. How the device functions in "Real World" (next) applications sets the flow chart to market retry, pricing strategies, training metrics, enterprise value etc... This has been especially true in the value based environment. In the GPO contracting conversation unless real value is demonstrated applicant will not be successful.

There are different types of PoC's. One type seeks to show clinical efficacy while another seeks to show why a device that is known to work can/should be adopted within an organization.

If clinical efficacy has been proven, then there is still no guarantee that a device will be adopted, particularly within a hospital or IDN. In this case, a PoC must show how the device fits into the organization's business model, considering factors such as reimbursement, physician relationships with competing devices, and resistance to change.

If the PoC is in a hosptial or IDN, then it generally will have to be driven by a strong internal champion who can get it through a Value Analysis Committee that often is seeking to reduce the number of vendors, and save money. If the PoC is outside a hospital or IDN (e.g., a free standing clinic or physician owned medical practice) then it will be important to demonstrate things such as profitability, patient throughput and patient satisfaction.

Travis "Grizzly" Jacobs What is the exit criteria for proof of concept? NASA and the DOD use a technology readiness level chart (TRL). This can be applied to product development and medical devices. I would revise this a bit to include heavier simulation use up front in the earlier TRL levels but they save concept applies

Experiment the medical device and gather data to analyze and improve.

PoC is attempt to demonstrate that I understood the user needs.

PoC is early "validation" that I'm designing the correct product.

Julie Omohundro Much thanks to everyone for all of the thoughtful responses. My take-away is that there is more than one type of PoC, because of often a new product idea rests on more than one concept. That suggests to me that the first step is to identify the concepts on which your product idea is based, and then determine what is needed to prove each concept to the satisfaction of investors.

(Or, speaking of Theranos, perhaps to your own satisfaction, as you may have a far better understanding of both the concepts and what constitutes proof thereof than investors.)

I think lessons learned in efforts to prove the concept, and the availability of a working prototype as a result of the proof, are happy side effects of the proving and offer their own considerable benefits, but that these are not the reasons to prove.

All of the responses provide great insight into PoC. To me, it means that the potential product feasibility has reached a maturation point that it meets the User Need and that the technology required to develop the product has demonstrated performance sufficient to move forward into product development.

Caitlin Morse, PMP Julie O. - I would argue that POC is not unique to medical devices, but sometimes goes by other names. I'm curious what the alternative is. If you are going to "skip" the POC, what are your clients proposing to do instead?

Julie Omohundro Caitlin, I agree, I think PoC applies to the development of any type of product.

As for many of my clients, they tend to have the opposite problem. As someone else in this group once put it, "They think they are nearly done, when they haven't even started." Once they've completed PoC, they think they've completed product development and are ready to submit a 510(k).

From my point-of-view PoC is often also about the notion that the most difficult development- and design tasks should be done first. That is often the case with implementing new technology into new products. So that is a important step, going from a concept based on a new technology into a product that can actually be produced. During that step you will normally run into (design) problems that nobody predicted for which you will need solutions before the project continues.
Disasters are waiting to happen when you separate technology development/PoC from the rest of the product development.