Summary: Many physicians do not recognize the complex process involved in turning an idea into a commercially viable medical device.
More than certainly constructing a prototype and trying to promote it, this complicated process calls for a deep knowledge of engineering, commercial enterprise, felony law, and regulatory necessities.
During their careers, it is not uncommon for physicians to experience many “eureka moments,” where they feel that they have simply located the next multimillion-dollar invention. But the road to success in entrepreneurship from what started out as a simple idea can be pretty difficult.
Unfortunately, what many physicians do not recognize is that the path to commercialization of their medical tool concept is oftentimes long, arduous, and expensive and requires a popular knowledge of business, law, engineering, and regulatory ideas. This article will study the vital steps to turning a concept into a marketable product.
The first step of product development calls for the evaluation of the concept. Once the idea for a brand new scientific device is shaped, or even a prototype is built, it is important to research its viability. Several elements are crucial to the achievement of a brand new clinical tool idea, ranging from creating a financially sustainable enterprise model to obtaining intellectual property rights to defend your idea. Inventors ought to consider their solutions in 4 key areas of product development.
Key Questions for Physician Inventors
Market Assessment
- What is the hassle your tool is attempting to resolve? Does this trouble create an unmet clinical device need in the market, and if not, why might clinicians use your tool over others already in the marketplace?
- What is the size of the market for your medical device? How many strategies are executed nationally and globally for which this device may be used?
- Who are the users of your tool, and could it be adopted by means of those potential users? What is the feasible market penetration of this device?
- Who is the closest competitor? What chances of the marketplace do they manipulate?
Business Model
- Can this device be evolved and manufactured at an affordable fee to allow aggressive pricing (engineering)?
- Are there any identified early adopters (key opinion leaders) who may want to perform beta testing on the device and end up as the early champions?
- How are you able to promote and distribute this tool (through unbiased sales distributors, hiring your personal income pressure, or partnering with a clinical device agency whose contemporary gadgets are synergistic with your tool)?
- What are the financial terms you prefer if you license the device to a clinical tool organization compared with launching a startup enterprise to commercialize the tool?
- What is the business model in case you launch a startup corporation to increase, manufacture, market, sell, and distribute this device? Who will fund the company (friends and a circle of relatives vs. angel investors or institutional traders)? Who will control the business enterprise on a daily basis (the control team)?
Product Pricing and Reimbursement Strategy
- What is the value of competing devices?
- Who could be the patron? Hospitals, outpatient clinics, pharmacies?
- Are codes currently available for repayment?
- How are selections made by way of your goal market concerning shopping?
- Are fee caps presently in the region?
- How will the device be sold? Reusable/one-time purchase, absolutely disposable, base unit with consumables?
Engineering
- Does the tool use technology that is currently available, or will the next generation want to be advanced?
- What are the engineering demands to broaden and manufacture this device?
- Does the tool use off-the-shelf components, or do additives need to be manufactured in particular for it? Can it be synthesized with biocompatible substances?
- Do you have the functionality to design, develop, and manufacture this tool in conformance with appropriate U.S. Food and Drug Administration and international legal standards? Physician inventors additionally want to recall to what elegance their gadgets will be assigned. Classification will determine the regulatory necessities for FDA approval to promote it within the United States. The purpose of FDA approval is to decide whether a tool can be used appropriately and efficaciously in step with its intended indication. Therefore, the scientific tool category is chance-primarily based and depends on the degree of difficulty in imparting a reasonable warranty of the tool’s protection and effectiveness. 1-three
- Class I: These gadgets pose a low to moderate risk of damage, are commonly easy in design, generally challenge widespread controls with a few exceptions, and makeup 47 percent of U.S. medical gadgets. Many Class I gadgets are exempt from premarket notification 510(k) requirements.
- Class II: These gadgets are more complex, pose mild to excessive danger, and are consequently subject to both fashionable and special controls, making up 43 percent of all U.S. medical gadgets. Special controls include performance standards of the device, post-market surveillance, unique labeling requirements, and pre-market record requirements. Many Class II gadgets require premarket notification, or 510(k) clearance before they can be advertised in the United States.
- Class III: These devices are high-danger and normally maintain or guide life, are implantable, or pose an unreasonable danger of infection or harm. They make up the remaining 10 percent of scientific devices. Such devices require premarket approval before advertising and marketing inside the United States, which ought to reveal legitimate scientific proof from medical trials that the tool is safe and effective for its intended use and layout.
The most important segment of developing a scientific device is the preliminary evaluation of the concept. By thinking about commercial enterprise, regulatory, and highbrow asset problems, you may be better equipped to solve the subsequent question: Is my clinical device concept feasible?
Whether the solution is “yes” or “no,” you will save money and time by now not pursuing a terrible tool concept and streamlining your intellectual property, commercial enterprise, and regulatory strategies as you flow ahead with growing your tool.
Turning an idea into a marketable product
Physicians play an important role in the clinical device innovation process, supplying tacit knowledge, technical know-how, and clinical stories and opinions that form the motivation and recommended requirements for new scientific gadgets. Yet, many physicians fail to undertake the right steps to ensure their ideas are protected and that suitable steps are taken to gain fulfillment.
Intellectual Property Strategy
An appropriate intellectual property strategy, despite the fact that typically a prolonged and steeply-priced system is critical while commercializing a tool to ensure that the device does not encroach on a formerly granted patent even as it provides the proper to exclude others from making and promoting it.
Despite common notions, a U.S. patent does not now supply the inventor with the right to make his or her tool, but alternatively, the right to exclude others from doing so. This approach begins with surveying previously granted patents, as well as the scientific literature, for any “earlier art” that would be used to disqualify your patent software. An earlier artwork seeks may additionally be perceived as so-called blocking IP, which may require a license agreement if you want to practice your invention.
For a patent to be granted, the device ought to be beneficial (software), new (novel), and nonobvious (to a person having everyday talent in the area of the invention). The term of a U.S. patent grant is 20 years from the date of filing of a non-provisional patent software. Four
A provisional patent is quite less expensive, does not require the filer to determine the claims of the patent, and establishes an early filing date with a 12-month priority benefit. For the simplest 12 months, a non-provisional utility patent needs to be filed before the provisional one expires.
In 2013, the United States transitioned from “first to invent” to “first to file.” Thus, if two inventors concurrently invent the same device, the U.S. Patent and Trademark Office will determine precedence based totally on the submitting dates in place of the date of the invention. 1, four Such intricacies of patent regulation call for that an inventor to employ patent lawyers to manage the drafting, submitting, and prosecution of the patent.
Research and Discovery Phase (Non-Regulated)
Upon determining whether your medical device idea is possible, the next step is to transition into the studies and discovery section, which is considered “non-regulated” as the design and testing of the device do not want to be managed under a satisfactory system per the FDA’s Code of Federal Regulations and global regulations. 2
This phase includes the introduction of a multidisciplinary group, design, prototyping, proof-of-concept testing, and iterative redecoration. It is likewise critical to display your finances with intent at some stage in this phase due to the fact that fees can escalate quickly.
Affording a big design crew is often tough for most health practitioner-inventors, so one ought to decide whether to rent the respective participants, use a medical tool engineering business enterprise, or rent a consultant to manage this method. Research is required to decide the pros and cons of each. A crew ought to be composed of individuals with know-how in, at minimum, the following regions:
- engineering and layout.
- human-factors engineering and usability.
- Business, finance, and accounting.
- Clinical and medical know-how within the medical field is meant for this use.
- Regulatory affairs and fine assurance
- Intellectual property and commercial enterprise law
In constructing the team, compare your personal talents so that you can hire partners that fill any understanding gaps. Many skilled medical tool experts will lend their know-how in exchange for an equity stake in your challenge. The era underlying your device will determine the level of know-how wanted within the group.
If you’ve got a complicated product, together with a Class II combination product that includes a mechanical design and drug shipping device, the engineering and medical knowledge wished can be one-of-a-kind from that wished for an easy Class I tool. 2
Design and prototyping
During the R&D segment, the focal point needs to be on prototype features and not always aesthetics (the layout and performance traits could be refined later). A computer-aided layout software program can provide lots of techniques for building a prototype. It is important to identify the maximum appropriate prototyping approach for the undertaking due to the fact that price and capability can range significantly depending on the method, as visible in Table 1. Five
Table 1: Comparison of prototyping methods
Proof-of-Concept and Iterative Redesign
Proof-of-idea checking out of the prototype is used to decide that the tool can be characterized as designed. This generally begins the use of benchtop engineering tests. For instance, if a tool is designed to clamp an artery without inflicting damage, the POC trying it out may consist of clamping a simulated vessel containing a strain transducer more than once to show that most strains did not attain the threshold for vessel harm.
If the prototype no longer bypasses checking out, a second round of layout and prototyping may be wanted. The technique of revising the prototype design in reaction to test effects is referred to as iterative redesign. It is continually more effective to invest money in layout and functional modifications in an advanced manner due to the fact that making changes later can be substantially more expensive.
The iterative remodel technique can provide records to define the general traits of the device so as to later end up with the design and overall performance specifications inside the regulated phase of design and improvement. These specs will then guide the improvement and trying out of methods, and substantiate the claims in your device for regulatory approval. With a practical prototype, the end of the R&D segment has occurred, allowing one to determine the viability of tool commercialization.
Defining Design and Performance
If you’ve got determined to continue with the commercialization of your tool, you should subsequently enter a process strictly ruled with the aid of a nice management system (QMS), which is a framework of policies and tactics for the way the merchandise is advanced and synthetic.
This device is regulated under good manufacturing practices (GMP) as specified by FDA 21 CFR Part 820 and ISO 13485. 6 The best control gadget is used to guide the whole tool development method, resulting in the generation of a design history file. The DHF is a compilation of all design, testing, and production information associated with the very last product.
A regulatory agency inclusive of the FDA can then audit the DHF and the associated facilities that helped develop and manufacture the device to ensure that the product is safe and powerful for use in step with the tool’s overall performance claims and regulatory necessities.
Design control files are generated to specify each characteristic the device will perform and the corresponding engineering specifications for that feature (i.e., “the device will traumatically draw close a vessel” and “the maximum compressive force shall not exceed 10 newtons.”)
These specifications are regularly changed at some point in the improvement procedure, but the adjustments ought to be nicely completed and documented according to a QMS for later evaluation with the aid of regulatory agencies.
For instance, if a preliminary engineering specification states that the most pressure of a surgical clamp is 10 newtons but the pressure requirement is modified to 5 newtons, trying out must be accomplished and documented to illustrate that the brand-new device layout does not exceed the new 5-newton specification.
This sort of mechanical and useful overall performance testing (verification testing) is a critical part of the improvement of nearly every scientific tool to illustrate that the tool meets layout specs. However, trying out the verification does not show that the device meets the user’s requirements. Validation testing is used for that cause. You can consider the 2 styles of testing in this manner: verification, where the tool meets layout specifications, and validation, where the tool meets personal needs.
Other sorts of testing that can be required include usability engineering and human elements engineering (UE/HFE), non-clinical trying out, and clinical checking out. UE/HFE is not a brand-new field, but it has become more and more important for FDA approval of medical device applications.The intention of trying out usability is to recognize how people interact with technology and to perceive capacity use-error styles that can harm customers or sufferers.
A use blunder is defined via several global requirements as “an act or omission of an act that results in a distinctive clinical tool reaction than meant by the manufacturerUsability testing is a methodical way to assess how well a medical tool works for the people who use it, the tool-human interaction, and the overall context in which it is used. 7
Non-medical tool testing is governed through suitable laboratory practices (GLP), as detailed by the FDA in Chapter 21 of the Code of Federal Regulations, Part 58 (21 CFR 50.8), in addition to different international requirements. 8 The term “non-scientific” or “preclinical” refers to testing that is done on non-human take a look at subjects. In addition to the FDA regulations, the use of non-human subjects in scientific tool testing is likewise established upon guidelines and overseen by numerous countrywide and local agencies.
Clinical testing of a scientific tool is regulated by the FDA via desirable clinical practices as described in diverse components of 21 CFR and worldwide guidelines. 2 Testing related to human topics is generally reserved for new and potentially risky clinical gadgets.
Before a scientific device can undergo scientific testing, an investigational tool exemption can be required via the FDA, depending on whether the device is considered a non-extensive or extensive hazard tool. Regardless, all clinical studies require institutional assessment board approval prior to initiation. Nine
FDA Application Type and Testing
Depending on the sort of tool, the FDA software will range, as will the amount of required testing. Table 2 lists the related guidelines, FDA programs, and device magnificence associated with the varieties of checking out.
Summary of Medical Device Testing Criteria in Table 2
Mechanical/Functional Testing
UE/HFE Testing
Non-Clinical Testing
Clinical Testing
Regulations
FDA 21 CFR 820, ISO 13485 (GMP)
ANSI, AAMI, and ISO Standards
FDA 21 CFR 58 (GLP)
FDA 21 CFR 812, 50, fifty-six, fifty-four, 820c
FDA Applications
Registration/Listing, 510(ok), PMA
510(k), PMA
510(okay), PMA
510(okay), PMA (IDE probable requirement)
Once the format records file has been completed, you’ll want to publish for regulatory clearance to the marketplace and sell your device. In America, a clinical tool needs to follow the CFR and be conventional with the help of the FDA, which requires proof that the device is stable and powerful earlier than it can be used.
In most other international locations, ISO standards are used for scientific device development. In Europe, a “CE” mark denotes conformance with the European Union’s Medical Devices Regulation concerning the tool, just like receiving FDA clearance in the United States.
An annual evaluation of 510(k) packages with the useful resource of the Emergo Group confirmed the commonplace duration of time to FDA clearance in 2016 had ended up being 191 days, with a 19 percent chance of device clearance in three months and a fifty-8 percent threat in six months. In 2014, 10 PMA projects required more time to be approved—about 262 days, according to the Regulatory Affairs Professionals Society.11 Although many packages are cleared at the primary submission, the FDA regularly submits letters of deficiency to candidates who’ve not provided sufficient information in their programs.
Once once more, investing in a tremendous institution with the wished know-how from the start, which incorporates regulatory and first-rate assurance, will help make certain your FDA software method is well-timed and fee-powerful.
Post-Market Surveillance
The very last segment of the medical tool lifecycle is publish-marketplace surveillance. The FDA calls for scientific device manufacturers to screen the safety and effectiveness of marketed gadgets and record those statistics to the employer. The FDA tracks both producers- and publicly referred to unfavorable occasions in the Manufacturer and User Facility Device Experience database. If enormous publishing-marketplace troubles are referred to, the producer can be required to preserve a tool in thought until there may be sufficient proof that those problems have been remediated. 12
Summary
Turning your clinical tool concept into a commercially possible product is a complex procedure that requires more than really building a strolling prototype and looking to promote it. The clinical device commercialization process calls for a deep understanding of engineering, business, prison, and regulatory necessities.
Because most physicians no longer have this information or interest, it’s miles greater important for clinical doctor-inventors to find a licensed crew with experience commercializing medical gadgets so that their devices can be added to the marketplace successfully at the same time as assembly all regulatory necessities.
Stuart Hart, MD, MBA, MS, FACOG, FACS, is senior director of world scientific affairs at Medtronic in Tampa, Florida. Mark Armstrong, MD, MSBE, is the accomplice scientific director for colorectal health and PACE curriculum supervisor at Medtronic in Tampa, Florida.
This article was first posted through the American Association for Physician Leadership in September 2016.
REFERENCES
- Food and Drug Administration. Overview of Device Regulation
- Food and Drug Administration. Medical Devices: Device Classification Panels
- Regulatory Affairs Professional Society.FDA Expects 2015 to See Record-High PMA Approval Rate
- According to the Regulatory Affairs Professionals Society, and the Food and Drug Administration. Device Post-Market MonitoringFood and Drug Administration. Learn if a scientific device has been cleared by using the FDA for marketing.
- S. Patent and Trademark Office. General Information Concerning Patents
- Mugan, J.Comparison of Prototyping Methods Good Manufacturing Practices for the Medical Device and Diagnostic Industries FDA Title 21 of the Federal Regulations, Part 820FDA Guidance Document: Usability and HFE
- Good Laboratory Practices (non-clinical testing) FDA Code of Federal Regulations, Title 21, Part fifty-8
- Food and Drug Administration.Information Sheet: Directions for Clinical Investigators, Sponsors, and IRBs: Common Questions About Medical DevicesEmergo Group. How long it takes America FDA to approve 510(k) submissions?
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