Introduction

All companies have milestones. From founding to exit, milestones signify key events--like the first few dollars in a corporate bank account, the year a company goes public, or the first people hired by a founder. But for companies operating in regulated industries like the medical technology sector, milestones play a more significant role in the life of the organization--without hitting certain milestones, there's a chance the company won't ever make it.

What Is Considered A Medical Device?

The medical device industry is a regulated industry with various categories of device types, so there are strict parameters globally around what's considered a medical device. Each nation has slightly different standards for how they regulate medical devices sold in their country, and the following guidance is from the FDA, the body regulating medical devices in the United States:

Per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is:

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

(A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).

If a product meets the above criteria, before a company can start collecting revenue from any product sales, there are a number of steps that company must take before putting it on the market.

The Milestone Framework for a Medical Device Company

In the development of a new medical device, most milestones revolve around the phases of design and development, with additional milestones falling between these various phases. Some items in the following list may differ by device classification and device type, especially with the emergence of SaMD (Software as A Medical Device):

• • Formal business entity filing
  • Market analysis
  • Map out financial requirements
  • Fund raising (seed funding round or grant writing, if applicable)
  • Learn about regulatory and clinical requirements

• • Build project plan and timeline
  • Prototype analysis, build, and iteration
  • Intellectual property filing
  • Fund raising (first funding round or grant writing, if applicable)
  • Clinical Trials or Pre-clinical trials
  • Identify reimbursement strategy
  • Identify initial regulatory strategy

• • Patent review
  • Confirming the right device was built for the intended customer use
  • Hire additional employees
  • Fund raising (additional funding round or grant writing, if applicable)
  • Regulatory submission (to the FDA or notified body depending on market)
  • Clinical validation

• • Product branding
  • Develop market launch plan
  • Final patent review
  • Develop sales plan
  • Regulatory clearance (by the FDA or notified body depending on market)
  • Finalize reimbursement strategy

• • Clinician training
  • Sales development
  • Post market surveillance
  • Quality audits
  • Design iteration

What Milestones Mean for Vendors Selling to A Medtech Company

A medical device company has different needs at each phase in their lifecycle. Vendors who recognize the need and understand the context surrounding the significant milestones in startup medtech companies sign more closed won deals and put less guess-work into value propositions. The following list represents an example scope of products and programs that could be helpful to startup medtech companies at each significant milestone:

Phase 1 - Ideation and Risk Analysis

• • Joining an incubator or accelerator program
  • Resources or courses on fundraising and grant writing
  • Clinical or Regulatory consulting for mapping our their journey to market
  • Book-keeping software or accounting services

• • Project management software
  • (QMS) Quality management system - this is a requirement for regulatory clearance
  • Intellectual property consulting or legal support
  • Clinical trial management software or hiring a (CRO) contract research organization
  • CAD software for physical product design
  • Software development for software as medical device products
  • Website design services

• • Contract manufacturing - for physical products
  • Consulting for final regulatory submission
  • Consulting for an ISO 13485 certification
  • A quality management system if they don't already have one
  • Internal training management solution

• • If not handled by the company, a solution for outsourcing sales
  • Branding, marketing, and reimbursement consulting support

• • Consulting for scaling or positioning for acquisition
  • HR software for managing employees

How to Find Significant Milestones for Medical Device Companies

Each milestone bears unique significance for a medical device company. If you're a vendor selling into the medtech sector and trying to identify the right timing to deliver particular products, timing is everything.

Zapyrus is the only sales enablement tool designed to notify vendors of the significant milestones for emerging and growing medical device companies across the globe. From funding announcements to clinical trial reports and various other milestones and data, Zapyrus helps vendors connect to the right team at the right time.

Let us know what you think.

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